OraSure Technologies, Inc. has completed its application to federal regulators seeking approval to sell its rapid HIV test over the counter. The company’s HIV test, OraQuick, is now available at hospitals, doctor’s offices, and other professional settings. The test can be used orally or though blood samples and yields results in about 20 minutes.

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OraSure Technologies, Inc., a market leader in rapid point-of-care infectious disease diagnostics and biological sample collection, stabilization and preparation products, announced today that it has submitted the final of three modules in its application to the U. S. Food and Drug Administration (FDA) for the approval of the Company's OraQuick® Rapid HIV-1/2 test for sale in the U.S. consumer or over-the-counter (OTC) market.

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A Bethlehem-based company is one step closer to selling over-the-counter HIV tests. OraSure Technologies, Inc., says it's submitted its final test results to the Food and Drug Administration for approval.

According to the Centers for Disease Control and Prevention, there are approximately 1.2 million people in the U.S. with HIV, and around 240,000 of those are unaware they have HIV, despite current HIV testing options.

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OraSure Technologies’ subsidiary, DNA Genotek, a provider of products for biological sample collection, stabilization and preparation, reported FDA clearance for DNA Genotek’s Oragene-Dx collection device. Oragene-Dx is a saliva DNA collection and stabilization device.

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DNA Genotek, a subsidiary of OraSure Technologies, Inc., received FDA clearance to market the Oragene Dx saliva DNA collection device. According to the company this is the first 510(k) approval for a DNA collection and stabilization device.

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OraSure Technologies, Inc. announced this week that the US Food and Drug Administration has granted it 510(k) clearance for its Oragene Dx collection device. Oragene Dx is the first and only saliva DNA collection and stabilization device to receive 510(k) clearance.

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DNA Genotek, a subsidiary of OraSure Technologies, Inc., received FDA 510(k) clearance Thursday for the Oragene-Dx collection device. That means doctors and clinics can use this device to provide patients a non-invasive way to collect DNA using saliva instead of a blood test.

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For many people few things are scarier than a trip to the dentist's chair. But Catrise Austin, New York City's dentist to the stars, says there is one thing that is definitely scarier than a visit to the dentist: not knowing your HIV status. So, since 2009, Austin has gone where few dentists have gone before, offering her clients free HIV testing with the OraQuick ADVANCE® rapid test. Austin is one of only two private dentists in New York City who offer the test through a program funded in part by the state Department of Health. The test includes a simple swab of the mouth and a 20-minute wait for results.

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Good news for doctor’s offices, outreach clinics and community-based organizations looking to use OraSure Technologies’ rapid test for hepatitis C virus (HCV): The test has been granted a CLIA waiver, meaning that its use is no longer limited to professionals who have received laboratory certification from the U.S. Department of Health and Human Services.

The OraQuick HCV test now can be used by more than 180,000 sites in the United States to test persons who are at risk for hepatitis C or have signs or symptoms of hepatitis.

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Health officials said Thursday they are recommending that any person living with HIV be offered AIDS drugs as soon as they are diagnosed with the virus, an aggressive move that has been shown to prolong life and stem the spread of the disease.

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OraSure Technologies’ rapid test for hepatitis C virus has been granted a CLIA waiver, meaning that its use is no longer limited to professionals who have received laboratory certification from the U.S. Department of Health and Human Services.

OraQuick’s assay is the first and only U.S. Food and Drug Administration (FDA)–approved rapid test to detect antibodies to HCV, which causes liver disease.

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OraSure Technologies, Inc. has received a federal waiver that expands access of its rapid hepatitis C test to include doctor’s offices, clinics and community-based organizations. OraSure estimates an additional 180,000 sites nationwide will be able to administer the test, which detects hepatitis C antibodies in about 20 minutes through the company’s OraQuick device.

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OraSure Technologies, Inc. announced that FDA has granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for its OraQuick HCV Rapid Antibody Test for use with fingerstick whole blood and venous whole blood specimens.

The OraQuick HCV Rapid Antibody Test is the first and only FDA-approved rapid test for the detection of antibodies to the hepatitis C virus (HCV).

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OraSure Technologies, Inc. received approval to sell its test for the hepatitis C virus to a wider range of clinics and doctors' offices in the United States, sending shares of the company up nearly 9 percent.

The company said on Tuesday the Food and Drug Administration expanded approval for the OraQuick HCV test, allowing more than 180,000 facilities to use it for detecting the serious liver disease in patients.

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OraSure Technologies, Inc. announces that the FDA has granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") for its OraQuick® HCV Rapid Antibody Test for use with fingerstick whole blood and venous whole blood specimens.

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OraSure Technologies, Inc. announced today that the U.S. Food and Drug Administration has granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") for its OraQuick® HCV Rapid Antibody Test for use with fingerstick whole blood and venous whole blood specimens. The OraQuick® HCV Rapid Antibody Test is the first and only FDA-approved rapid test for the detection of antibodies to the hepatitis C virus (“HCV”).

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The Food and Drug Administration has granted a waiver to OraSure Technologies, Inc. for its OraQuick HCV Rapid Antibody Test. This is the first and only FDA-approved rapid test for the detection of antibodies to the hepatiis C virus (HCV).

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Bethlehem-based OraSure Technologies, Inc. will now be able to offer its rapid Hepatitis C test to doctors' offices and clinics, dramatically expanding the market for the recently approved product. The rapid Hepatitis C diagnostic test — OraQuick HCV Rapid Antibody Test —uses finger-stick or venous blood samples to diagnose the liver disease in patients who are showing symptoms, providing results within 20 minutes. It has not been approved for use in pediatric patients.

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OraSure Technologies, Inc. has received a federal waiver that expands access of its rapid Hepatitis C test to include doctors offices, clinics and community-based organizations. OraSure estimates an additional 180,000 sites nationwide will be able to administer the test, which detects Hepatitis C antibodies in about 20 minutes through the company’s OraQuick device. The company makes a similar device to detect HIV.

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OraSure Technologies, Inc. announces that the Food and Drug Administration (FDA) has granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for its OraQuick® HCV Rapid Antibody Test for use with fingerstick whole blood and venous whole blood specimens.

“Today, more than 4 million Americans are infected with hepatitis C and the vast majority do not know it,” says Dr. Willis C. Maddrey, president of the Chronic Liver Disease Foundation. “Hepatitis C is a leading cause of chronic liver disease, cirrhosis and liver cancer. However, new therapies are now available that can effectively treat a high percentage of people with HCV infection, making expanded and accessible testing for HCV a critical step in fighting this epidemic.”

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Bayou Classic fans are being encouraged to take a free HIV test while in New Orleans for the annual football matchup between archrivals Southern University and Grambling State.

On game day, between 10 a.m. and 1 p.m., free HIV testing will be available outside the Superdome at the Louisiana STD/HIV Program Health Fair tent. According to the Department of Health and Hospitals, more blacks are infected with HIV than any other racial or ethnic group. Testing will consist of a quick, painless swab of the mouth, and results will be available in just 20 minutes.

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At one Department of Motor Vehicles' office in the nation's capital, motorists can get a driver's license, temporary tags and something wholly unrelated to the road: a free HIV test.

In a city with one of the highest percentages of residents living with HIV or AIDS, health officials have spent the last year test-driving the HIV screening program. Since the program began last October, more than 5,000 people have been tested at the DMV site and gotten results while they waited. Now, officials are expanding the program, offering testing for the first time at an office where Washington residents register for food stamps, Medicaid and other government assistance.

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When Virginia Commonwealth University’s first-year students arrived on campus this fall, they received a seemingly bizarre invitation—to “Spit for Science.” A team of researchers at VCU, which is based in Richmond, is looking into whether genes might predispose some individuals to struggle with drug and alcohol use, or emotional problems. To accomplish this, they asked students to take part in a confidential survey: first they had to fill out an online questionnaire about their moods, their behaviour and relationships, and then provide a saliva sample, which is rich in DNA. These samples were collected with a unique device created by DNA Genotek, an Ottawa-based company that corners the market on high-tech spittoons.

“Spit for Science” is just one example of the many ways this sampler is being used. DNA Genotek (which was acquired by Pennsylvania-based OraSure Technologies, Inc. in August) has thousands of clients around the world, according to Curry, and scientists are using the device to study everything from obesity to tropical disease.

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OraSure Technologies, Inc. has appointed a new board member experienced in selling consumer health care products who the Bethlehem company says will help OraSure's efforts to sell more products over-the-counter. The company named Gerald M. Ostrov, a former Johnson & Johnson executive, to its board of directors with an initial term expiring in 2013.

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OraSure Technologies, Inc. has appointed former Bausch & Lomb CEO Gerald Ostrov to its board directors, according to a news release today. His term expires in 2013. Ostrov led Bausch & Lomb from 2008 to 2010, restructuring the business after its sale to private equity investors. Before that, he worked at Johnson & Johnson, where he became group company chairman responsible for the pharmaceutical giant’s Worldwide Vision Care business for about eight years until retirement in 2006.

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This summer a pilot program was launched to raise awareness of the importance of testing for the hepatitis C virus (HCV). Step Up to the Plate Against Hepatitis C is a partnership between the American Liver Foundation (ALF), Merck, the Coalition on Positive Health Empowerment, and OraSure Technologies, Inc. to reach out to people during the great American pastime, baseball.

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In support of National Latino AIDS Awareness Day, The Latino Commission on AIDS and other NYC community groups launched a testing campaign called "Take the Train? Take the Test!", where free HIV testing was available on Wednesday at 25 different subway stations across New York City. News 12 Brooklyn filmed one of the subway stops, Marcy Ave, which was holding free OraQuick ADVANCE® HIV testing.

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In support of National Latino AIDS Awareness Day, a coalition of community groups banded together to fight AIDS and set up mobile testing stations near 25 subway stops on Wednesday. Testing took place in neighborhoods like Washington Heights, Manhattan. Organizers helped administer oral swabs, which brought back results in about 20 minutes.

"The Centers for Disease Control brought out the new statistics that say 20 percent of the new infection rate are among Latinos, so the virus is still prevalent in our community," said Melissa Ramirez of the Latino Commission on AIDS.

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"Toma el tren y hazte la prueba del VIH", es el llamado que distintas organizaciones sociales hicieron hoy desde las escalinatas de la alcaldía. Como parte de las actividades del Día Latino Nacional para la Concientización del Sida (NLAAD, por sus siglas en inglés), que se conmemora el 15 de octubre, hoy en 25 estaciones del tren subterráneo y repartido por los cinco condados a partir de las 12 del día y hasta las 6 de la tarde, los pasajeros se podrán realizar el test oral del VIH, de forma rápida, simple y sin dolor.

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¿Toma el tren? Hágase la prueba del VIH es la nueva campaña del Día Nacional Latino para la Concienciación del SIDA (NLAAD, por sus siglas en inglés). Con ella, se facilitará la prueba gratuita y sin dolor del virus del sida en 25 estaciones de los cinco condados durante el día de hoy, de las 12pm a las 6pm. Si desea saber en qué estaciones estarán presentes visite esta web http://www.nlaad.org/subway/

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National Latino AIDS Awareness Day is October 15th, and the Latino Commission on AIDS is offering free rapid oral fluid screenings on Wednesday as part of its efforts to get the word out. 'Get tested; Know Your Status' is the message from the Commission.

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DNA Genotek is throwing the doors open to researchers with "innovative and novel" ideas for the company's saliva collection projects. The OraSure Technologies, Inc. subsidiary, which is based in Ottawa, announced a grant program Tuesday with the winning research proposal receiving US$30,000 and up to 500 sample collection kits.

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OraSure Technologies, Inc. recently co-sponsored the "Step Up to The Plate Against Hepatitis C" initiative as part of a nationwide effort by Major League Baseball to bring attention to the causes and treatment of Hepatitis C at several ballparks throughout the country. Sponsored by Merck, the American Liver Foundation, Coalition of Positive Health Empowerment and OraSure, the program offers free hepatitis C testing and promotes education and support for the prevention, diagnosis and management of hepatitis C.

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Houston Astros manager Brad Mills discusses the "Step Up to The Plate Against Hepatitis C" campaign and testing initiative at Minute Maid Park. Mills speaks to the importance of getting screened for hepatitis C, saying, "we're trying to get the notice out to a lot of people and that's why we wanted to partner with OraSure, American Liver Foundation, Merck, and Coalition for Positive Health Empowerment because it's so important."

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Dr. Galati and Houston Astros manager, Brad Mills, discuss the "Step Up to The Plate Against Hepatitis C" initiative. Both spokespeople discuss hepatitis C and the importance of getting tested. "The testing is real easy and you can find out fairly soon, it only takes about 20 minutes to find out if you are affected," says Mills. Free screening was offered at Minute Maid Park.

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Houston Astros manager and spokesperson Brad Mills, and Dr. Galati, a hepatologist from the Liver Specialists of Texas, discuss the "Step Up to The Plate Against Hepatitis C" campaign. Mills talks about the ease of getting tested for hepatitis C and how he partnered with Merck, OraSure, ALF, and Coalition for Better Health to offer free testings at Houston's Minute Maid Park.

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Douglas Michels, President and CEO of OraSure Technologies, Inc., spoke with Gregg Greenburg at TheStreet about how the rising demand for faster Hepatitis and HIV tests is driving the Company's growth.

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When it comes to testing people living with HIV for hepatitis C virus (HCV) antibodies using rapid assays, some tests appear more accurate than others, according to a U.S. Centers for Disease Control and Prevention (CDC) study of three assays reported in the September 15 issue of The Journal of Infectious Diseases. OraSure's OraQuick® HCV Rapid Antibody Test was the most accurate of the three in specimens that also contained HIV antibodies, followed by Chembio's DPP HCV Test and, lastly, by MedMira's Multiplo Rapid HIV/HCV Antibody Test.

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Going to the Cubs game? Why not get tested for a potentially deadly disease while you're at it?

In a FOX Chicago studio interview, Cubs Analyst Keith Moreland and Dr. Steven Flamm from Northwestern University discuss the free OraQuick® rapid hepatitis C screenings taking place at Wrigley Field on August 23rd as part of a national awareness campaign called "Step Up to the Plate Against Hepatitis C".

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The Cardinals are stepping up to the plate against Hepatitis C. Starting Monday, August 22, fans will be able to get free OraQuick® Hepatitis C screenings at Busch Stadium. It's part of a nationwide effort by Major League Baseball to bring attention to the causes and treatment of Hepatitis C.

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A new HIV rapid test platform, designed to deliver test results in 10 minutes, may also detect HIV earlier in the course of infection than currently available rapid tests, new research findings suggest. The new rapid HIV test is based on the existing OraQuick® HIV rapid test platform. Findings regarding the test were presented by Lisa A. Kurtz, a senior scientist at OraSure Technologies, Inc, in Bethlehem, Pennsylvania, during an oral session at the 2011 National HIV Prevention Conference (NHPC) here. Researchers are also working on developing an oral hepatitis C virus (HCV) test.

In another presentation at the same meeting, Jennifer Fuld, with the New York City Department of Health and Mental Hygiene, presented data on an oral swab rapid HCV antibody test developed by using the same OraQuick® technology. The finger stick version of the OraQuick® HCV Rapid Antibody Test was approved on June 25, 2010, and is currently the only available HCV test that uses a finger stick. The current study evaluated the oral swab form of this test and found that overall, 97.5% of rapid test results matched those of the EIA. In 6 of the7 discordant pairs, the rapid test result agreed with the polymerase chain reaction result.

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OraSure Technologies, Inc. has completed its US $53-million acquisition of Ottawa's DNA Genotek, which was first announced in late July. In a previous conference call with analysts, DNA Genotek chief executive Ian Curry said the only change is he will report to OraSure's President and CEO Douglas Michels, rather than DNA Genotek's board.

The 70-person firm expects to keep growing in the wake of the acquisition. It was one of OBJ's Fastest-Growing Companies in 2010 with three-year revenue growth of 153 per cent.

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Bethlehem-based Orasure Technologies, Inc. said today it has closed enrollment for clinical studies the company is conducting in order to develop an over-the-counter version of its rapid HIV test. Completing the studies is a necessary step before the company can submit an application to the Food and Drug Administration.

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Going to Saturday's Cubs game? Well, then you'll have a chance to see the Cubs and get tested for Hepatitis C. The free testing is part of Step Up to the Plate Against Hepatitis C. This initiative, launched by Merck, in partnership with ALF, Coalition on Positive Health Empowerment and OraSure Technologies, Inc. is attempting to educate people about the illness. Educational materials about the disease also will be provided Saturday.

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OraSure Technologies, Inc., which competes in the oral fluid diagnostics market, said it would buy privately held DNA Genotek for $53 million. DNA Genotek is based in Ottawa and serves 3,000-plus customers in more than 100 countries, including research universities and hospitals in the United States. DNA Genotek's lead product, the Oragene DNA sample collection kit, is an all-in-one system for the collection, stabilization, transportation, and purification of DNA from saliva.

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OraSure Technologies, Inc., which develops and manufactures oral fluid diagnostic devices, is expanding into the molecular diagnostics market with its $53 million cash acquisition of DNA Genotek. OraSure says that the deal will provide it with a complementary portfolio of products that enable collection, stabilization, transportation, and storage of high-quality DNA and RNA samples.

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OraSure Technologies, Inc., a Bethlehem maker of medical diagnostic products, today announced it is buying for $53 million a Canadian company that makes products used to collect DNA samples from saliva.

DNA Genotek, based in Ottawa, Canada, provides tools used to collect DNA and RNA samples used by more than 3,000 customers around the world, including hospitals and universities. OraSure officials said the company's products are a good fit with OraSure's diagnostic tools that can check oral fluid samples for HIV.

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OraSure Technologies Inc. today acquired DNA Genotek Inc., a privately held Canadian maker of oral-fluid collection devices used in molecular diagnostics, for $53 million. OraSure said the deal increases its ability to create effective disease-detecting products because DNA Genotek's expertise in molecular science complements OraSure strengths.

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DNA Genotek, a 13-year-old Ottawa company that develops saliva-based DNA sample collection kits, says it has reached an agreement to be acquired by U.S.-based OraSure Technologies, Inc. (NASDAQ:OSUR) for US$53 million.

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To mark National HIV Testing Day on June 27, Dr. Kevin Fenton, director of National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, CDC, released a statement that said in part: "On this National HIV Testing Day, we have good news to report. In just three years, CDC's expanded HIV testing efforts facilitated almost 3 million HIV tests in hard-hit areas across the nation, helping nearly 20,000 Americans living with HIV learn their status for the first time. A recent report showed that more Americans than ever before have taken an HIV test at least once in their lifetime, and more HIV-infected people than ever know their status."

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OraSure Technologies, Inc. recently launched its FDA-approved flu test for the detection of influenza type A and type B, including H1N1 viral infections. The nasal swab test, called the OraSure QuickFlu™ Rapid Flu A+B Test, provides results in a little as 10 minutes.

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Six years after it was initiated, most people still don't know a new HIV/AIDS testing method yields results in under half an hour. "If more people knew it only took 20-30 minutes, more people would come," said Tim Schuetz, marketing director for the Colorado AIDS Project. The new method, which uses a quick and painless oral swab, was probably what inclined nearly twice as many people to walk into the Colorado AIDS Project's free testing center in the past year, Schuetz said.

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It was a beautiful day for an HIV test. Priscilla Brown, 50, of North Chicago wore a sticker that declared "I got myself tested" after a simple, self-administered gum swab that yielded results in 20 minutes.

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ELYRIA — More than 42 people were tested for HIV during free screenings in Lorain and Elyria on Monday. The exams, which were all anonymous, were oral swab tests — called OraQuick — done in the front of the mouth on the top and bottom gum lines. Results come back in 20 minutes and are a 99 percent accurate measure of the presence of HIV.

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Today is National HIV Testing Day. Scott McGrew talks to Douglas Michels, the President and CEO of OraSure Technologies, Inc, a company that offers a saliva test designed to detect HIV.

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Today, June 27, is National HIV Testing Day, which was created by the The National Association of People with AIDS. You can find a testing site near you through the CDC's website hivtest.org.

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Today is National HIV Testing Day and Santa Clara County is trying to help people get tested. It is offering free HIV screenings at two locations. Currently, most HIV tests are done through blood samples, but one company is starting to provide saliva tests. Orasure says it is a 20 minute test for people who don't like needles.

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Congressman John Lewis (D-Atlanta) opened the doors on what's usually a private affair and took an HIV test in front of a TV news crew. The test involves a simple swab of the gums, and the results take 20 minutes. "It's very important that we do this," Rep. Lewis said. "HIV is growing so fast here in the Southeast and in Atlanta, especially with young people."

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As part of National HIV Testing Day Monday, health workers will offer free tests at Church Inc. in Oildale and the Royale Palms Motel on Union Avenue. That's in addition to rapid testing offered throughout the year on a sliding fee schedule at places such as Clinica Sierra Vista and the Kern County Public Health Department. The rapid test, in which a patient's mouth and gums are wiped with a swab, reduces the waiting time from about a week to 20 minutes. The results are comparable to the traditional tests. And since this version doesn't require a blood draw, it's easier to take on the road, reaching more and higher-risk people.

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"From 2006 to 2010, D.C. nearly tripled the number of publicly supported HIV tests from 42,000 to 110,000," according to the city's latest HIV report, released June 15. "Overall, the Department of Health is encouraged that expanded testing efforts ... and routine testing in medical settings reached many early in their infection and those who were unaware of their diagnosis." While testing opportunities abound in the District, the days leading up to and including June 27 increase those opportunities substantially, primarily using a 20-minute, oral-swab test from OraSure Technologies. Among the primary organizations leading the charge for additional testing to mark the occasion is Whitman-Walker Health, founded in 1978 as a gay men's STD clinic, partnering with groups such as AmeriCorps and the HIV Working Group at The Center, the area's LGBT community center.

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On Tuesday, the Kaiser Family Foundation announced that it had teamed up with the drug store chain, as well as the nonprofit group Greater Than AIDS, to distribute informational resources and offer one-on-one medication counseling for people living with HIV/AIDS. Free rapid oral HIV testing will be offered from June 22 to 24, thanks to guidance from the CDC and test kits donated by OraSure Technologies. Conducting the tests will be state and local health departments as well as community-based organizations.

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What happens at an HIV test?

Getting tested is simple. Like many centers around the country, ASC uses OraQuick Advance Rapid HIV-1/2 Antibody test, which is a simple mouth swab to see if HIV antibodies are present — that means no needles and no blood work (although blood tests and urine tests are still available for those who prefer them). With rapid testing, results are available in about 20 minutes. At many testing sites, testing is free, completely confidential and includes a pre- and post-test counseling session.

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Obtaining an accurate diagnosis of hepatitis C often means travelling a long road, with many stops along the way. First, you'll need a blood test to check for antibodies to the hepatitis C virus (HCV), an analysis that can take as long as two weeks. But even with antibodies, you might not be infected: 15–25% of exposed people clear the virus without needing any treatment.

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Eliminating the need for a blood draw, the OraQuick HCV Rapid Antibody Test is a single-use immunoassay for the qualitative detection of hepatitis C virus (HCV) antibodies in fingerstick whole-blood specimens. This test, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HCV (state of infection or associated disease not determined) in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis C infection. The rapid, point-of-care test provides results in 20 minutes. The product also is available for use with venous whole-blood specimens in persons at risk for HCV infection.

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MTV's "10 Most Outrageous Sex Myths" show featured a segment on HIV myths and Vinny from The Jersey Shore demonstrating the OraQuick ADVANCE® HIV test.

The Jersey Shore is an American reality television series that premiered on MTV in December 2009 in the United States. The series follows the lives of eight housemates spending their summer at the Jersey Shore. Dubbed a cultural phenomenon, the series has garnered record ratings for MTV, making it the network's most viewed series telecast ever.

Watch the full segment featuring HIV myths and the demonstration of the OraQuick ADVANCE® HIV test here

Watch the online promo here

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OraSure Technologies Inc., in Bethlehem, PA, recently announced the appointment of Stephen S. Tang, Ph.D., as a member of the company's Board of Directors. Dr. Tang will serve as a Class I Director with an initial term expiring at the Company's 2013 Annual Meeting of Stockholders.

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OraSure Technologies Inc., a Bethlehem, PA, company that provides oral-fluid specimen-collection devices, has appointed Stephen S. Tang to its board. He is President and Chief Executive Officer of the University City Science Center, an urban research park and business incubator based in Philadelphia.

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University City Science Center President Stephen Tang will serve as a Class I Director on the board for Bethlehem-based OraSure Technologies, which has developed groundbreaking diagnostic products, like its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test.

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OraSure Technologies, Inc. has received FDA approval for its OraQuick® HCV Rapid Antibody Test, which detects HCV anti-bodies with a fingerstick whole blood sample. The fingerstick whole blood claim is the second application to be approved by the FDA for the OraQuick® HCV test. The first product, approved in June 2010, required venous whole blood specimens.

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OraSure Technologies, Inc. announced that it has submitted to the U.S. Food and Drug Administration ("FDA") an application for a waiver under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") for its OraQuick® Hepatitis C Virus (HCV) Rapid Antibody Test for use with venous whole blood and fingerstick whole blood specimens.

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OraSure Technologies Inc. is requesting federal regulators approve its rapid Hepatitis C test for wider use. The Bethlehem diagnostics company said today it has applied for a waiver with the Food and Drug Administration that would allow distribution of the test at clinics, doctor's offices and community organizations. Shares rose after the announcement.

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Debra Fraser-Howze is a force to be reckoned with - former Chairwoman of the National Black Women's AIDS and HIV Network, founder and long-term President of the National Black Leadership Commission on AIDS, now Senior Vice President of Government Relations at OraSure Technologies, Inc. On this National Women and Girls HIV/AIDS Awareness Day, NAPWA had the good fortune to talk with her, and took away a wide ranging interview on her years working to end the HIV epidemic, the need for public-private partnerships, and the role of Black women in protecting themselves and stopping the spread of HIV in their community.

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The firm's OraQuick® HCV rapid antibody test has received PMA approval for use in detecting hepatitis C virus with a fingerstick whole blood sample, OraSure Technologies, Inc. announced Feb. 22. The diagnostic device gained a PMA approval in June 2010 for use with venous whole blood in persons at risk for HCV infection, but the new indication significantly expands the test's flexibility and versatility, the company says. "By eliminating the need for a blood draw, health care providers will be able to identify more individuals infected with hepatitis C and get them into care," said OraSure President and CEO Douglas Michels. Providing results in 20 minutes, OraQuick® HCV is the only FDA-approved rapid, point-of-care test for the detection of HCV antibodies, according to the firm.

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OraSure Technologies, Inc. announced today that its OraQuick® HCV Rapid Antibody Test has been approved by the FDA for use in detecting HCV antibodies with a fingerstick whole blood sample. The fingerstick whole blood claim is the second application to be approved by the FDA for the OraQuick® HCV test. The product received an initial approval for use in persons at risk for HCV infection with venous whole blood specimens in June 2010.

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The FDA has approved the use of blood obtained through a finger stick for a hepatitis C virus (HCV) test. The OraQuick® HCV Rapid Antibody Test was initially approved in June 2010 for use with a venous whole blood sample. The device is the only point-of-care detection device for hepatitis C with FDA approval, according to a statement from maker OraSure Technologies, Inc.

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OraSure Technologies, Inc. of Bethlehem, which makes products used to test for HIV, hepatitis and drug use, received federal approval for a key product that tests for hepatitis C, the company announced Tuesday.

The U.S. Food and Drug Administration has approved the company's OraQuick® HCV Rapid Antibody test, which detects hepatitis C, with a finger-stick blood sample. The agency in June approved use of the product with a whole blood sample. The test provides results in 20 minutes.

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OraSure Technologies, Inc. in Bethlehem has received U.S. Food and Drug Administration approval for a rapid hepatitis C test, the company announced today. The approval for the new OraQuick® HCV Rapid Antibody finger-stick test follows about eight months after the FDA approved a similar blood-draw test for the blood-borne pathogen. The difference between the tests is how the sample is obtained, said Ron Ticho, OraSure's vice president of communications.

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OraSure Technologies, Inc. of Bethlehem, which makes products used to test for HIV, hepatitis and drug use, received federal approval for a key product that tests for hepatitis C, the company announced Tuesday. The U.S. Food and Drug Administration has approved the company's OraQuick® HCV Rapid Antibody test, which detects hepatitis C, with a finger-stick blood sample. The agency in June approved use of the product with a whole blood sample. The test provides results in 20 minutes.

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By the time today's teenagers were old enough to read, new drugs were available that meant HIV was no longer a death sentence. But with infections among youth and young adults in the U.S. still rising, one senior at The Urban School of San Francisco decided his peers needed more than just another classroom lesson.

Nearly all 75 members of the senior class got tested for HIV in the school gym Friday. Though the test being used (OraQuick®) – a simple swab of the inside of the mouth – can provide same-day results, students and administrators agreed that they should receive their results in private and at home. They will hear via telephone or email on Tuesday.

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By the time today's teenagers were old enough to read, new drugs were available that meant HIV was no longer a death sentence. But with infections among youth and young adults in the U.S. still rising, one senior at The Urban School of San Francisco decided his peers needed more than just another classroom lesson. Nearly all 75 members of the senior class got tested for HIV in the school gym Friday. The testing was voluntary, and organizers of the unusual event will not make any results public.

Though the test being used - simple swab of the inside of the mouth - can provide same-day results, students and administrators agreed that they should receive their results in private and at home. They will hear via telephone or email on Tuesday.

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Next Friday, seniors at San Francisco's Urban School are taking part in an unusual experiment: The entire class of 80 students is slated to get tested for HIV, in what appears to be the nation's first such group test for the virus by a high school class. On testing day, Urban seniors will get tested in the gym by adult volunteers during study hall, lunch and other openings in their classes. Dr. Conant will oversee mouth-swab tests, with supplies donated by the maker of the tests, OraSure Technologies, Inc.

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A rising number of influenza cases in the South Bend area has prompted Notre Dame Health Services to prepare for a spike in the number of visits Notre Dame students make to St. Liam's Hall in the next few weeks. Mary Ellen McCaslin, assistant director of clinical services, said Health Services has noticed the appearance of influenza strains on campus over the last two weeks.

"We do what is called an (OraSure) QuickFlu™ Test and we have had some positives in the last few weeks," McCaslin said. "We expect to follow the trends seen in surrounding regions, which indicate a rise in the incidences of influenza cases."

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Heroin use is five times more prevalent than previously thought, according to a study conducted by Quest Diagnostic Drug Testing using a drug-testing product made by OraSure Technologies (OSUR) in Bethlehem. Quest analyzed more than 320,000 oral fluid samples from the U.S. workforce between January and June 2010, according to OraSure. OraSure's Intercept Drug Testing system was used to collect the samples, and it detected heroin use in .04 percent of the samples. That compares to a heroin-use rate of .008 percent detected in urine samples.

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New testing methods using saliva found heroin use is five times more common in the general workforce than experts thought, according to Quest, the nation's largest provider of diagnostic testing. Heroin was found in 0.04 percent of 320,000 employees screened with spit tests that are harder to tamper with and easier for companies to collect than the older urine tests, the Madison, New Jersey-based company said.

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The U.S. government says more than a million people are now infected with HIV or AIDS. It's estimated that 20 percent of them don't know they have the disease, but a new testing method is making headway in diagnosing potential cases early and easily. Mobile testing labs, like the one in South Carolina which use OraQuick® rapid HIV tests, are helping that cause, popping up across the U.S. in droves.

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OraSure Technologies, Inc. announced the impending launch of the OraSure QuickFlu™ Rapid Flu A+B Test, an FDA-approved in vitro rapid qualitative test for the detection of influenza (flu) type A and type B, including H1N1 viral infections. The test specimen is collected with a nasal swab, nasopharyngeal swab or nasal aspirate/wash and results are available in as little as 10 minutes.

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Bethlehem medical-device maker OraSure Technologies is working on a new product: a rapid test for influenza, including the H1N1 virus, that uses a nasal swab and has results in as little as 10 minutes. The OraSure QuickFlu test, which the company announced today, is intended to help quickly diagnosis different forms of the flu so that patients can receive appropriate care.

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Bethlehem medical-device maker OraSure Technologies is working on a new product: a rapid test for influenza, including the H1N1 virus, that uses a nasal swab and has results in as little as 10 minutes. The OraSure QuickFlu test, which the company announced today, is intended to help quickly diagnosis different forms of the flu so that patients can receive appropriate care. More than 200,000 people are hospitalized with flu complications each year, according to the Centers for Disease Control.

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With an estimated 1-in-5 HIV-positive Americans unaware of their infection, increased opportunities for testing are critical. The saliva test is as easy to use as a home-pregnancy kit and is as accurate as the blood tests. Typical HIV tests require a vial of blood and are sent to a laboratory that returns results in 2 to 14 days. With saliva testing, a toothbrush-like device is inserted into the mouth and gently scraped and the saliva is tested for the presence of HIV antibodies. In 20 minutes time, results are available.

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Over the past 27 years, our greatest tool in battling the HIV virus has barely changed.

Until now.

A Pennsylvania biotech company is currently awaiting FDA approval for the first ever over-the-counter HIV test. In just 20 minutes, the test will reveal whether a person has contracted the virus. No health clinics or hospitals. No agonizing waiting for lab results. Needless to say, a take-home HIV test is huge news – and could be a game-changer for the company. If it's approved, the business – and share price – will blast significantly higher.

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OraSure Technologies, Inc. announced today that Tony Zezzo is the company's new executive vice president of marketing and sales. Zezzo assumed the role Monday. He will oversee the company's global marketing and sales operations, including the domestic and international sales teams for OraSure's infectious disease and substance abuse businesses, marketing, and client services/customer care.

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On December 1, 2010, Douglas A. Michels, President and CEO of OraSure Technologies, Inc, alongside New York State Senator Tom Duane and Assemblyman Darryl C. Towns, rang the NASDAQ opening bell and kick-started another day at the stock exchange in Manhattan.

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Bethlehem medical device-maker OraSure Technologies received approval from the Food and Drug Administration to extend the shelf life of its leading product, the OraQuick® HIV test, to 24 months from 18, the company announced Monday. OraSure officials said the longer shelf life, achieved through improved manufacturing, should help boost sales of the product used to detect HIV through a sample of oral fluids or blood.

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OraSure Technologies, Inc. said today it has begun enrolling individuals to complete clinical studies of its OraQuick® rapid HIV test, a necessary stage before the company can apply to sell the product over the counter. Users will test themselves on oral fluid samples with at-home kits designed to detect HIV antibodies within 20 minutes.

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The Second Annual HAMP (HIV Awareness Music Project) concert was a New Orleans music event featuring Katey Red, Vockah Redu, Truth Universal, Big History, Intimate Stranger, the Fleur De Tease Burlesque Review, and Quintron and Miss Pussycat. The event was dedicated to promoting HIV awareness, and OraQuick HIV testing was offered during the show.

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On Saturday, local musicians will promote HIV awareness at the Second Annual HAMP (HIV Awareness Music Project) at One Eyed Jacks. The musical review''s performers will undergo OraQuick rapid HIV testing in a bid to show patrons how easy it is to get screened and know your status. HAMP is the brainchild of Dr. MarkAlain Dery, an infectious-disease specialist at Tulane Medical Center.

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One in five people with HIV is unaware they are infected, according to the U.S. Center for Disease Control and Prevention. On Dec. 1, Elon University recognized the annual World AIDS Day, which works to lower this statistic, through a free AIDS screening service for students. The process was simple enough: on Dec. 1, interested individuals filled out forms with demographic information and risk indication for HIV (according to sexual activity), followed by a brief counseling session with an Alamance Cares trained staff member and the test, called OraQuick.

"OraQuick is a swab that tests the mucosa in your mouth with results in 20 minutes and it is 99 percent accurate," Beam said. "The OraQuick test is either negative or reactive. If negative, that means no HIV virus was found and as long as it has been three months from the risky behavior, the person knows they are negative."

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A simple test that takes about the same amount of time as it does to cook a frozen pizza could provide students with much needed peace of mind. Free, and confidential, HIV Testing has been available at the IU South Bend Health and Wellness Center for years.

Many students are uncomfortable with the idea of getting tested for HIV, or STIs in general. The misconception may be that there is a long drawn-out process of taking blood that needs to be sent to a lab for analysis. The OraQuick test that is used by AIDS Ministries, the local organization that provides testing, is accurate and time efficient. The OraQuick test only requires people to rub a testing strip over their gums for a few seconds to get enough bodily fluid for it to work. The strip is then placed in a vile of solution that begins the test. There are no needles or two-week waits with this test.

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OraSure President and CEO Douglas A. Michels participated in an interview with Global Vision / CNBC Europe on December 1, 2010, in order to raise awareness for World AIDS Day and call attention to the importance of being tested and knowing one's HIV status. The interview took place at the NASDAQ MarketSite, where OraSure Technologies opened the market.

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OraSure President and CEO Doug Michels participated in an interview with TheStreet.com on December 1, 2010, in order to raise awareness surrounding World AIDS Day and call attention to the importance of being tested and knowing one''s HIV status.

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The OraQuick® HCV Rapid Antibody Test received an Innovation Award from Popular Science in the publication''s annual "Best of What''s New" issue. More than four million Americans are infected with the hepatitis C virus (HCV), but three million of them don't know it because testing is expensive and results take weeks. HCV is responsible for half of all liver transplants in the U.S. yet is curable if detected before it infects the liver. OraQuick delivers a diagnosis in 20 minutes.

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VIP Smiles, owned by celebrity dentist Dr. Catrise Austin, announced today the availability of free rapid HIV testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test in their Manhattan office. In recognition of World AIDS Day on December 1st, VIP Smiles will be offering free HIV testing by appointment from December 1 - 15th, 2010.

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Bayou Classic fans can get free tests for HIV at a daylong health fair Saturday outside the Superdome, where more than 50,000 fans will gather for the annual football game between Southern and Grambling State universities. The 20-minute oral test – also available at parish health offices – is more than 99 percent accurate, and a negative test is considered definite. OraSure Technologies, Inc. makes the test kits and sponsored the health fair.

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OraSure Technologies, Inc. announced that the editors of Popular Science have named the OraQuick® HCV Rapid Antibody Test one of the top technology innovations of 2010. As a winner of a "Best of What''s New" Award, the OraQuick HCV Rapid Antibody Test was recognized for its technology and being the first ever rapid, point-of-care test approved by the FDA for the detection of antibodies to the hepatitis C virus (HCV).

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OraSure Technologies, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) for the Company to conduct the final phase of clinical testing for FDA approval of its OraQuick Rapid HIV-1/2 Antibody Test for sale in the consumer or over-the-counter (OTC) market. Receipt of the IDE allows the Company to proceed with the final phase of clinical testing which consists of a study in which individuals will conduct unsupervised self-testing using the investigational OTC version of the OraQuick HIV test with an oral fluid collection.

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OraSure Technologies announced Monday that its proposed over-the-counter OraQuick Rapid HIV test has entered the final stage of review by the U.S. Food and Drug Administration. The OraQuick HIV test, which can test for the virus in 20 minutes using oral fluids and blood samples, is the company's leading product. But right now it is only approved for use in hospitals and clinics. If it is approved for over-the-counter sales, people could determine if they may have the virus without having to visit a clinic or mail blood samples to a lab.

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OraSure Technologies, Inc. has received government permission to complete the final phase of clinical studies on its rapid HIV test, a necessary step before it can seek approval to sell the device over the counter. The OraSure test, known as OraQuick, can detect HIV antibodies within 20 minutes. OraQuick is currently available to doctors and hospitals for use on whole blood and oral fluid samples.

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The Hyacinth AIDS Foundation held its 25th Anniversary Gala and Silent Auction on November 13, 2010 in New Jersey. The Foundation recognized three local individuals for their tireless work and astounding contributions to the community: Congressman Frank Pallone, Douglas Michels, CEO of OraSure Technologies, and Laurence E. Ganges, assistant commissioner of the division of HIV and AIDS services in the New Jersey Department of Health and Senior Services.

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Clinton Township resident and CEO of OraSure Technologies, Douglas Michels, was recognized by the Hyacinth AIDS Foundation at its 25th Anniversary Gala and Silent Auction on Saturday, November 13. Michels has dedicated his career to advances in the healthcare industry, particularly in the areas of HIV, hepatitis and drugs of abuse diagnostics. Last year, he was appointed to the Presidential Advisory Council on HIV and AIDS.

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OraSure Technologies, Inc. recently announced that the editors of Popular Science named the OraQuick HCV Rapid Antibody Test one of the top technology innovations of 2010. As a winner of a "Best of What's New" award, the OraQuick HCV Rapid Antibody Test was recognized for its technology and being the first ever rapid, point-of-care test approved by the FDA for the detection of antibodies to the HCV (hepatitis C) virus.

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Popular Science Magazine has named OraSure's rapid Hepatitis C test as one of the top 100 technical innovations of the year. The first-of-its kind test provides results in 20 minutes.

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One of the latest products from OraSure Technologies, a rapid test for Hepatitis C, has been recognized by the magazine Popular Science as one of the top 100 technological innovations of the year. The product is a big breakthrough for the company, whose leading product is the OraQuick HIV test, a rapid test for HIV that uses similar technology. Hepatitis C is far more prevalent than HIV, so the company sees a strong market for its latest product.

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Bethlehem diagnostics company OraSure Technologies, Inc. has drawn the national spotlight for its rapid Hepatitis C test. Popular Science magazine has recognized the OraQuick HCV Rapid Antibody Test as one of the top 100 technology innovations of 2010. Editors of the magazine included the device in its "Best of What''s New" awards to be published in the December issue.

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Also published in the Daily Record

The Hyacinth Foundation is the oldest and largest AIDS service organization in New Jersey. On Saturday, the foundation will mark its 25th year with a gala and silent auction at the Hyatt Regency Hotel on Albany Street, beginning at 7 p.m. The foundation will honor U.S. Rep. Frank Pallone, D-6th; Douglas Michels, president of OraSure Technologies, a company that makes medical testing products, and Laurence Ganges of the state Department of Health and Senior Services.

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The Hyacinth AIDS Foundation, New Jersey''s first and largest AIDS service organization, will recognize three local individuals for their efforts in the fight against HIV/AIDS at its 25th Anniversary Gala on November 13. The Foundation will recognize Congressman Frank Pallone; Douglas Michels, CEO, OraSure Technologies for making rapid HIV testing available and affordable to millions of people worldwide; and Laurence E. Ganges, assistant commissioner, Division of HIV/AIDS Services, New Jersey Department of Health and Senior Services.

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OraSure Technologies just received FDA approval for the OraQuick HCV Rapid Antibody Test, the first rapid test to detect antibodies in whole blood specimens to the hepatitis C virus (HCV). Designed as a point-of-care test, it will yield results in 20 minutes to identify more individuals infected with HCV.

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Residents of the nation's capital can now get a driver's license and free HIV testing -- at the same time. A Department of Motor Vehicles branch in southeast Washington is offering testing for the disease under a pilot program aimed at educating residents and reducing stigma. Results of the free oral test are available in 20 minutes. Test takers will get $15 to go toward DMV costs, but Wood emphasizes that knowing one's status is the primary incentive.

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People going to get a driver's license in Washington, D.C. also now have the option of getting a free HIV test in the same trip. Anyone who comes into the branch can take a test and get their results within 20 minutes. A collaboration between both public and private partnerships and a $250,000 grant allowed the program to start.

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This Sunday, more than two dozen predominantly black churches in Chicago – with a combined membership of about 35,000 – offered free HIV screenings to strip away the stigma associated with the disease. Following a national trend, African-Americans in Chicago are affected in far greater numbers than other racial groups by the HIV/AIDS epidemic, according to the AIDS Foundation of Chicago. Blacks represent about 37 percent of the city's population yet account for 56 percent of people living with HIV.

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With a new law now in place requiring that HIV tests routinely be offered to all New Yorkers between the ages of 13 to 64, health providers here in the city and across the state are already preparing for a surge of new cases. NY1's Kafi Drexel filed the following report.

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How does the industry feel about the rapid changes and outside forces that seem to continually work against the lab's success? ADVANCE asked around, and it turns out, for many industry insiders, these challenges are expected, if not embraced, and there is a trend of confidence that the industry will overcome these obstacles just as they have in the past. ADVANCE spoke to Steve Lee, PhD, executive vice president and chief scientific officer at OraSure, who added point-of-care testing (POCT) to the list of tools that will help keep the laboratory industry strong despite the ongoing external forces.

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The Wall Street Journal recently featured the success of rapid HIV testing programs in New York City hospitals such as St. Barnabas Hospital-Bronx, highlighting the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test that provides accurate results in 20 minutes and has helped connect thousands of HIV positive people to care. OraSure's rapid HIV testing quickly and easily test patients across the hospital including the Emergency, Ambulatory Care and Inpatient departments, among others.

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This online slideshow contains highlights from the exhibit hall floor at the AACC/ASCLS Annual Meetings and Clinical Lab Expo held July 25-29 in Anaheim, CA. The OraQuick® HCV rapid antibody test is featured on slide 8.

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Screening people for hepatitis C should become easier. In June, the Food and Drug Administration approved a rapid blood test developed by OraSure Technologies that gives an answer in 20 minutes rather than several hours needed if the sample is sent to a lab. Future versions might use a mouth swab, allowing screening to be done at churches, street fairs and other gatherings.

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OraSure Technologies, Inc. announced today that its OraQuick® Hepatitis C ("HCV") Rapid Antibody Test has been approved by the U.S. Food and Drug Administration ("FDA") for use in detecting HCV antibodies in venous whole blood specimens, making it the first rapid HCV test approved by the FDA for use in the United States.

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The global reach of hepatitis C, its seriousness as a chronic disease, and the fact that most individuals who are living with HCV are unaware that they are infected are some of the reasons why OraSure Technologies developed rapid HCV testing, says Douglas A. Michels, president and CEO of OraSure Technologies. OraSure''s OraQuick HCV Rapid Antibody Test has become the first FDA approved rapid HCV test in the United States. Based on the same technology platform used by the OraQuick rapid HIV tests, the test works by detecting HCV antibodies and offers results in twenty minutes. In the U.S., the test is approved for use with venous whole blood specimens. In the European Union, the test has been approved since December 2009 for use with venous whole blood as well as finger stick whole blood, oral fluid, serum, and plasma.

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Bethlehem-based OraSure Technologies, Inc. has received FDA approval to for a blood test that can detect hepatitis C virus antibodies in about 20 minutes. The point-of-care test, to be used in people age 15 and older, is designed for those at risk or who are already showing symptoms of the virus, which is spread by exposure to infected blood and can lead to liver ailments.

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June 27th is National HIV Testing Day (NHTD). Now in its 16th year, NHTD is a nationwide effort led by the National Association of People with AIDS (NAPWA) that aims to increase awareness of the critical importance of HIV testing, early diagnosis and prevention to the millions of Americans who are at risk for HIV -- and to the even greater number who do not know that they might be at risk.

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According to our Guide to HIV / AIDS, Mark Cichocki, R.N., there are approximately 1.1 million people living with HIV in the United States. Of those 1.1 million people, 20% have no idea they are infected.

There are several ways you can be tested for HIV, but did you know that you can be tested at your dental office? Last year, I interviewed Dr. Catrise Austin, a dentist in New York City who offers the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test to her patients.

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Dr. Timothy Friel describes hepatitis C as a silent epidemic. Most patients don't even know they have it, and the symptoms could take years, if not decades, to manifest, said Friel, vice chairman of research at the Lehigh Valley Health Network.

The network, which operates Lehigh Valley Hospital, started collaborating in 2007 with Bethlehem-based OraSure Technologies, Inc. on a clinical trial for a blood test that would detect the virus in about 20 minutes. Three years later, the trial is over and the test -- the first of its kind -- is now going to become available to patients nationwide. The U.S. Food and Drug Administration on Friday approved its use. The approval marks a milestone for OraSure, which previously gained notoriety by developing a rapid test for HIV.

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The transmission of hepatitis C hit its peak in the 1970s, but doctors didn't discover the virus until 1989. The first test to detect the virus, a blood-borne pathogen that attacks the liver, didn't arrive until 1992. Now, 18 years later, Bethlehem-based OraSure Technologies, Inc. has developed a rapid test for the disease that Dr. Timothy Friel, of Lehigh Valley Health Network, describes as a silent epidemic.

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OraSure Technologies Inc said it received U.S. regulatory approval to market a hepatitis C virus (HCV) test, OraQuick, sending its shares up 16 percent. The approval of the device to detect HCV antibodies in unmodified blood specimen collected from the vein raises hopes of the test getting the nod for multiple specimen types such as oral fluid and fingerstick whole blood sample types.

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The OraQuick HCV Rapid Antibody Test to detect antibodies from the hepatitis C virus has been approved by the U.S. Food and Drug Administration. The blood diagnostic is a test strip that does not require an additional device to obtain results in about 20 minutes.

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The OraQuick HCV Rapid Antibody Test to detect antibodies from the hepatitis C virus has been approved by the U.S. Food and Drug Administration. Some 3.2 million people in the United States are chronically infected with the virus, and some 17,000 new infections are reported each year, government statistics show.

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Bethlehem medical device-maker OraSure Technologies said Friday it has received regulatory approval to sell a rapid Hepatitis C virus test that can detect the virus in a blood sample within 20 minutes. A local health expert says the test will be a big help in diagnosing and treating patients for an ailment that claims an estimated 12,000 lives each year.

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The U.S. Food and Drug Administration today announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.

The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis. HCV is transmitted through exposure to infected blood, which, for example, can occur during intravenous drug use. The virus can also be transferred from an infected mother to her child. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer.

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The Atlanta mayor usually comes into the room to meet with a sometimes-testy city council. But this time he was met by a man trained in administering rapid HIV tests.

"This is a disease that impacts all of the city," Reed had said at a press conference earlier to urge widespread testing. "That is why I am going to participate and be tested as well."

After a battery of medical questions, the technician handed the mayor an oral swab and instructed him on how to conduct the test – basically gathering saliva.

"Oh," Reed said. "It is like brushing my teeth."

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Intercept, the first oral fluid drug test, was cleared by the FDA for use in 2000. Since then, oral testing has seen significant advances, explained Ron Ticho, senior vice president for corporate communication for OraSure Technologies, the Bethlehem, Pennsylvania-based manufacturer of the Intercept drug test. Currently, this test may be used to detect 10 different drugs, and, over the course of the next few months, several more drugs will be added.

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OraSure Technologies, Inc. has received approval to affix the CE mark to its OraQuick® Rapid HCV Antibody Test. The CE mark is required to sell this test in the countries of the European Union.

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A staggering 3.6 million Americans say they''re at risk of HIV but haven''t been tested, according to a 2005 survey. Researchers are hoping to change this imbalance by introducing rapid oral fluid HIV tests to an unexpected setting: the dentist office.

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OraSure''s vice president for government and external affairs, Debra Fraser-Howze, was honored along with five local women for her leadership and achievements which have made the world a better place.

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This week, the Buckeye state will become Black Hollywood East, as movie and TV stars flock to participate in the Test 1 Million Ohio Celebrity Tour. "There has never been an effort to mobilize the Black community in Ohio like this," says Mamie Harris, CEO and founder of IV Charis, a Cincinnati- and Northern Kentucky-based AIDS-service organization and the event co-sponsor. Other tour supporters include the Ohio Minority Health Commission, Orasure Technologies and a statewide coalition of 27 organizations.

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Launching the OraQuick Advance HIV/HCV tests last week, Dr Amin Al Amiri, CEO of Medical Practice at the ministry said that the test results have an accuracy of 99.6 percent. This is delivered within 20 minutes of testing as opposed to the regular blood test that could take up to five hours.

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When New York dentist Catrise Austin began offering rapid HIV tests to her dental patients last August, she was surprised at how receptive they were to the idea. "A lot have said, 'Wow, you just saved me an extra trip to the doctor' or 'Not even my doctor has offered me an HIV test.'"

The test, which Austin offers free to her patients, "literally takes two minutes to administer," and involves a quick mouth swab. Results are ready in 20 minutes and easily read by Austin, who went through training and certification by test maker OraQuick.

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A few local professionals are having a major impact on the fight against HIV and AIDS not only here, but nationwide...even worldwide. Debra Fraser-Howze, Senior Vice President of Government and External Affairs for OraSure Technologies, stopped by 69 News at Sunrise recently to talk about the recent accomplishments in the HIV/AIDS epidemic. In the second segment, Jake Cole from the Health Department at St. Luke's Hospital also discusses the success of the mobile HIV testing van.

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A local business leader has been appointed to advise President Barack Obama's global HIV/AIDS strategies. Douglas Michels, Clinton Township resident and president and CEO of OraSure Technologies of Bethlehem, Pa., in February was appointed to serve as a member of the Presidential Advisory Council on HIV/AIDS by Department of Health and Human Services Secretary Kathleen Sebelius.

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Doug Michels has spent the last five years building OraSure Technologies in Bethlehem into an industry leader. The oral and fluid diagnostics company has particularly made its mark with its award-winning HIV testing kits and devices.

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The National Black Leadership Commission on AIDS spent the day on Capitol Hill on Wednesday, March 17. Their purpose was to push for H.R. 1964 Elimination of HIV/AIDS Act of 2009 to be approved. This push comes during a time when President Obama is making a final pitch for health care reform.

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The National Black Leadership Commission on AIDS (NBLCA) led more than 50 influential members of the clergy to Capitol Hill to push for approval of H.R. 1964/S. 3011, the National Black Clergy for the Elimination of HIV/AIDS Act of 2009, which lays out a comprehensive plan for the federal government to lead the way in marshaling resources in the fight against HIV and AIDS and targeting them where they are most needed. According to the CDC, even though Blacks represent about 12 percent of the U.S. population, they accounted for almost half of new AIDS diagnoses in 2007 – and in DC, 81 percent of all AIDS cases are among African-Americans.

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Dr. Shannon Lee Hader, the current Director of the HIV/AIDS Administration within the DC Department of Health, discusses the newly released D.C. HIV/AIDS report by Mayor Adrian M. Fenty in conjunction with Department of Health (DOH) Officials. For the first time, we can report that there is a decline in new AIDS cases in the District of Columbia," said Mayor Fenty.

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The senior pastor of Historic Ebenezer Baptist Church took a rapid oral fluid HIV test in front of the congregation to raise awareness for HIV/AIDS prevention among African Americans, in honor of National Week of Prayer for the Healing of AIDS. "We don't like to talk about these things in church," Rev. Raphael Warnock told the congregation. "We've got to fight the unholy trinity of silence, shame and stigma."

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Every 35 minutes, a woman tests positive for HIV in the US. It's time to focus on how to address the needs of women and children. In order to explain this clearly, Debra Fraser-Howze wrote an opinion editorial about the significance of this day and the impact of HIV on women.

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March 10th marked the 5th annual National Women and Girls HIV/AIDS Day (NWGHAAD). The Office of Women''s Health held a press event at the National Press Club in Washington, DC to raise awareness of the increasing rates of HIV/AIDS among women and girls. Every 35 minutes, a woman tests positive for HIV in the US. The opening speaker at the event was OraSure''s VP of Government and External Affairs, Debra Fraser-Howze, and the event featured the U.S. Surgeon General, Regina M. Benjamin.

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On the 5th annual National Women and Girls HIV/AIDS Day (NWGHAAD), Genevieve Ruffin from the DC Dept. of Health discusses the importance of rapid oral hiv testing with Fox News and took an OraQuick ADVANCE® HIV test to draw attention to the critical role that HIV prevention and education play in stemming the spread of HIV/AIDS among women.

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Dr. Eugene Schiff and Maria de Medina from the Center for Liver Diseases at the University of Miami School of Medicine discuss HCV testing and how rapid point-of-care testing improves identification and prognosis.

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The messages, and their safe delivery, are all the more important when one considers that at the end of 2006, an estimated 1.1 million people were living with HIV infection in the U.S. Almost half—roughly forty-nine percent—fall into one of those big-picture categories: African Americans. In a 2008 article in the San Francisco Chronicle, Congresswoman Barbara Lee quoted a Black AIDS Institute stat that said "if Black America were a separate country, it would rank 16th worldwide in the number of people with HIV (ahead of Botswana, Côte d'Ivoire, Lesotho or Swaziland)."

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If Debra Fraser-Howze has one message it is, get tested for HIV, now. She spoke on February 16 as part of Lehigh''s Health, Medicine, and Society program''s spring semester speaker series on public health.

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OraSure's VP of Government and External Affairs, Debra Fraser-Howze, spoke at Lehigh University's spring speaker series about AIDS and health policy from the perspectives of the nonprofit and the corporate sectors.

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When the new Presidential Advisory Council on HIV/AIDS has its first meeting, a native Auroran will be part of the team.

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Orasure's presidential appointment coverage
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The most recent statistics from the Centers for Disease Control and Prevention report 1.1 million Americans are infected with HIV/AIDS. The HIV Alliance and the University of Oregon's Black Student Union are teaming up to offer free HIV testing on campus.

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The decades-old war on the AIDS epidemic took a swing into the digital age today, enlisting iPhones and other mobile communicators in a social media and text messaging campaign described as the first of its kind in New Jersey. Debra Fraser-Howze, OraSure's VP of Government and External Affairs, speaks to the Star-Ledger about the importance of HIV/AIDS prevention among the youth population.

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Douglas Michels, chief executive officer of OraSure Technologies in Bethlehem, has been named to the Presidential Advisory Council on HIV/AIDS. The council provides advice, information and recommendations to the president through the secretary of Health and Human Services on domestic and global HIV/AIDS policy issues.

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Department of Health and Human Services Secretary Kathleen Sebelius announced the appointment of 24 new members to the Presidential Advisory Council on HIV/AIDS (PACHA).

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U.S. Senators Arlen Specter and Bob Casey today applauded the appointment of Douglas A. Michels, the CEO of OraSure Technologies, located in Bethlehem, PA, to the Presidential Advisory Council on HIV/AIDS (PACHA).

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While much has been accomplished to eliminate the scourge of HIV/AIDS since its discovery nearly 3 decades ago, the condition is far from eliminated. Global organizations such as the World Health Organization have worked diligently to raise awareness of HIV, with a focus on detection. In addition, the Centers for Disease Control and Prevention (CDC) has determined that testing and treatment of sexually transmitted diseases (STDs) can be an effective tool in preventing the spread of HIV.

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The global AIDS epidemic is raging on, and OraSure's testing technology has monumental implications for millions of people worldwide. The ease of use and speed of OraSure's HIV test will help curb the spread of AIDS, a remarkable achievement for this former Ben Franklin Technology Partners company based in Bethlehem.

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A private dentist in New York City has added a $15 rapid-result HIV test to the routine services offered at the practice. "The topic of HIV can be uncomfortable for some, so we decided we would talk about it with patients in a matter-of-fact way, the way we talk about cavities and gum disease," Catrise Austin says.

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OraSure Technologies, Inc. and Roche Diagnostics announced that the companies have signed an agreement for the worldwide commercialization of homogeneous fully automated oral fluid drugs of abuse assays with OraSure's Intercept® oral specimen collection device. The oral fluid assays use Roche's KIMS (kinetic interaction of micro-particles in solution) technology and are being jointly developed under an agreement previously signed by the parties.

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OraSure Technologies, Inc. announced an agreement today with Roche Diagnostics to automate its oral-based drug tests, a much quicker process than the existing lab-based methods. The agreement allows OraSure to use Roche assays — or screening procedures — that are compatible with automation.

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OraSure Technologies (OraSure) and Roche Diagnostics (Roche) have signed an agreement for the worldwide commercialisation of homogeneous, fully automated oral fluid drugs of abuse assays with OraSure's Intercept oral specimen collection device.

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The theme of the show was the top five emerging health threats including HIV and AIDS, MRSA, Tuberculosis, H1N1 Virus and H1N1 Prevention. The HIV and AIDS segment features POZ Editor in Chief, Regan Hofmann and Orasure's OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test.

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Medical professionals have begun implementing innovative new ways to make HIV more accessible and convenient. The OraQuick ADVANCE® Rapid HIV Antibody Test, now used in a growing number of dental schools and clinics throughout the United States, is the only rapid HIV test to be approved by the FDA for use with oral fluid.

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A routine dental cleaning now may come with an unexpected option: an HIV test. Some dental locations, especially in New York City, are offering HIV screenings to patients through a fast and inexpensive oral test.

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Public health experts in the US are calling on dentists to carry out tests for HIV. Approximately one in 10 Americans visit a dentist but not a physician each year, according to the Centres for Disease Control.

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Debra Fraser-Howze, founder of the National Black Leadership Commission on AIDS and Vice President of Government and External Affairs for OraSure Technologies, is on a mission to raise awareness and lower infection rates in the African-American community. She is using her health care community experience and her corporate world connections to make moves.

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Ms. Debra Fraser-Howze has been in fighting HIV/AIDS for 27 years. She founded the National Black Leadership Commission on AIDS in 1987, which is the oldest and largest non-profit of its kind in the U.S. She is currently the Vice President of Government and External Affairs for OraSure Technologies.

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"Don't forget to floss" may soon be followed by "and don't forget to wear a condom," as dentists and clinics have started to administer state-of-the-art saliva tests that can detect HIV in minutes.

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Test maker OraSure Technologies, Inc. said Tuesday it moved a step closer to selling its hepatitis C test in the European Union. The Bethlehem, Pa., company received approval to affix a CE mark to its OraQuick Rapid HCV Antibody Test.

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OraSure Technologies, Inc. has received regulatory approval from the European Union to sell a rapid test that detects Hepatitis C. The company said today the approval marks the first such test available in the 27 countries that make up the EU. OraSure shares rose on the news.

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OraSure Technologies, Inc. has received regulatory approval from the European Union to sell a rapid test that detects Hepatitis C. The company said today the approval marks the first such test available in the 27 countries that make up the EU. OraSure shares rose on the news.

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OraSure Technologies announced today that it has received approval to affix the CE mark to its OraQuick(R) Rapid HCV Antibody Test. A CE mark is required to sell this test in the 27 countries that currently make up the European Union.

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According to the latest figures of the United Nations Organisation UNAIDS, more than 33 million people worldwide are currently living with HIV and AIDS. Since it can take up to ten years before the outbreak of the disease, early testing can be a life saving factor.

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After receiving a National Medical Association award for her work fighting HIV/AIDS in the African-American community, Debra Fraser-Howze speaks about today's challenges (misinformation), priorities (testing) and promises (over-the-counter HIV tests) in fighting the virus.

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La soberana de belleza hizo un llamado a realizarse la prueba de VIH como hizo ella.

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There are women warriors fighting on the frontlines against HIV/AIDS in our community. Debra Fraser-Howze has been on active duty for the past 27 years, all while raising two successful and accomplished daughters, and founding the National Black Leadership Commission on AIDS (NBLCA) in 1987, the nation's largest, non-profit organization of its kind that's still advocating on our behalf today.

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After receiving a National Medical Association award for her work fighting HIV/AIDS in the African-American community, Debra Fraser-Howze speaks about today's challenges (misinformation), priorities (testing) and promises (over-the-counter HIV tests) in fighting the virus.

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Despite the tough economy, OraSure Technologies employees doubled holiday donations to the Volunteer Center of the Lehigh Valley for its 10th Annual Lehigh Valley 'Holiday Hope Chest' Project to a record quantity of 300 – that translates to more than one donated Chest per employee. OraSure's employees who generously gave their personal time and effort to the project which included purchasing toys, securing empty shoe boxes and gift wrapping each individual package.

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People around the world are coming together to raise awareness of HIV and AIDS today as we observe World AIDS Day. It's estimated that about 33 million people around the globe live with HIV or AIDS, but how are we doing in the local fight? Kristen Wenrich, Community Health Risk Behaviors Manager at the Bethlehem Health Bureau, and Ron Ticho, from OraSure Technologies in Bethlehem, stopped by 69 News at Sunrise to give us a "report card."

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With the emergence of oral fluid-based screening for HIV, Dr. Catrise Austin, CEO of VIP Smiles, realized that it made sense to do HIV screening in the dental office setting. Dr. Austin has a long-standing interest in HIV, and is concerned that HIV statistics don't seem to be improving. She started offering an HIV screening test in her office earlier this year – and since insurance doesn't cover the test, she's providing it for free.

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Miss Universe takes the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test to draw attention to the critical role of HIV testing and prevention education play in stemming the spread of AIDS on World AIDS Day.

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Orasure Technologies, the Bethlehem maker of the OraQuick HIV test and other medical products, has announced a meeting with a government advisory committee regarding one of its proposed products.

The company met Tuesday with the Blood Products Advisory Committee, which advises the U.S. Food and Drug Administration on the safety and effectiveness of products. Orasure met with the agency regarding its proposed over-the-counter HIV test kits, which would allow people to test themselves for HIV in their homes.

Orasure is seeking regulatory approval to sell its OraQuick HIV test over the counter. The device is currently approved for use by clinics and hospitals. The company expects the annual U.S. market for an over-the-counter HIV test kit could exceed $500 million.

Orasure officials said Tuesday's meeting helped clarify which clinical studies are needed to get the product approved.

Orasure employs about 300 people, mostly in Bethlehem.

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OraSure Technologies met Tuesday with the U.S. Food and Drug Administration to push plans to sell a rapid HIV test over the counter.

The Bethlehem diagnostics company said in a news release it shared clinical results with the FDA. OraSure said the meeting was productive, and it plans further talks with the FDA's blood products advisory committee in efforts to gain approval.

OraSure makes OraQuick, a test that can detect the HIV virus within 20 minutes through oral or blood samples. It is now available in hospital and lab settings but not over the counter.

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This summer the Veterans Health Administration mandated that HIV testing be offered as part of routine medical care that is provided to all veterans. HealthBusinessBlog's editor David Williams spoke recently with Dr. Henry Anaya, an HIV/AIDS researcher at the VA in Los Angeles to get his perspective on the rationale for the program, how it's being rolled out, and the expected impact.

Mr. Williams focused on rapid oral testing for HIV that enables the patient to receive his or her result during the same appointment where they're tested. The big advantage of that is that it radically reduces the number of patients lost to follow-up.

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OraSure Technologies, the Bethlehem maker of tests for HIV and other medical products, reported its first quarterly profit this year due to strong sales growth. But the company still expects to end 2009 in the red.

The company on Wednesday reported third-quarter earnings of $1.8 million, or 4 cents per share, which compares with a loss of $1.8 million, or 4 cents per share in the same period a year ago.

Orasure saw a boost in sales by clearing a $2.2 million order backlog created by manufacturing difficulties in the second quarter that have since been fixed. Sales of the company's leading product, the OraQuick HIV test, were down in the second quarter due to the manufacturing problems.

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Bethlehem- OraSure Technologies, Inc. has swung to a quarterly profit on rising revenue.

The local diagnostics company said Wednesday it earned $1.8 million, or 4 cents a share, in the third quarter. That's up from a loss of about the same amount in the year-ago quarter.

OraSure said revenue rose 28 percent to $21.6 million, up from $16.9 million in the third quarter of 2008.

OraSure said revenue gains reflected double-digit sales growth among its infectious-disease products, which includes OraQuick, a rapid HIV test, as well as cryosurgical systems and insurance-risk-assessment testing products.

The South Bethlehem company said those increases helped offset lower sales in its substance-abuse testing products. Shares of OraSure closed regular-hours trading at $3.31 on the Nasdaq, about the midpoint of its 52-week range.

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Dr. Catrise Austin, a dentist in New York City, recognized the importance of HIV testing and the knowledge that comes with a diagnosis of HIV. She introduced the OraQuick ADVANCE Rapid HIV-1/2 Antibody test to her dental practice, VIP Smiles, and was happy to answer my questions about a dentists role in HIV testing.

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Since November 2005, the U.S. Food and Drug Administration (FDA) has considered the possibility of an over-the-counter (OTC) rapid HIV test. This summer, OraSure Technologies completed another leg of the FDA approval process required to put its oral swab HIV tests on the shelves of local drug stores.

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To raise awareness of HIV/AIDS in the Latino community, Miss Dominican Republic 2009 Mariela Lucas took a rapid HIV test at an event on October 7 hosted by the New York City NLAAD Planning Committee.

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Liliana Rañón (Latino Commission on AIDS) and Mariela Lucas (Miss Dominican Republic USA) discuss the seventh annual National Latino AIDS Awareness Day and the importance of OraQuickADVANCE® rapid oral fluid HIV testing on ABC's "Tiempo", a weekly round-table discussion show about topics affecting and relating to Hispanic citizens.

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Nueva York — Como inicio de la campaña nacional de concientización del SIDA, que se realiza ya por séptimo año consecutivo y que organiza la Comisión Nacional Latina sobre el SIDA (NLAAD, por sus siglas en inglés), la Señorita República Dominicana USA Mariela Lucas se hizo la prueba oral para detectar el HIV.

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In support of the 7th annual National Latino AIDS Awareness Day (NLAAD) on October 15, 2009, OraSure has partnered with the Latino Commission on AIDS to launch the National Latino AIDS Awareness Day Rapid HIV Testing Initiative. At the NLAAD kickoff event, Miss Dominican Republic U.S. (Mariela Lucas), Dr. Monica Sweeney (NYC DOHMH, Bureau of HIV/AIDS Prevention and Control) and Carlos Santos (MTV3res) all took the OraQuick ADVANCE® rapid HIV test using a simple oral fluid sample in front of the public to raise awareness for HIV/AIDS prevention among Latinos.

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Orasure Technologies, the Bethlehem maker of OraQuick rapid HIV tests, announced Thursday a new contract with a purchasing group that represents 2,200 hospitals in the country.

The contract with Premier Purchasing Partners of Charlotte, N.C., effective Nov. 1, gives the group's member hospitals prenegotiated prices and terms for Orasure's rapid HIV tests, which can detect the virus within 20 minutes using oral fluids, finger sticks or blood.

The contract also helps Orasure reach more hospitals directly, an effort it launched this year when it moved to a direct sales model rather than relying on medical distributors to sell its products.

"We believe this contract will expand our growth opportunities among Premier members, particularly as hospitals across the country expand their HIV testing programs," Orasure Chief Executive Officer Douglas A. Michels said in a news release. Hospitals are offering more HIV testing during emergency room and outpatient clinic visits, Orasure officials said. Orasure shares closed at $3.09 Thursday, up nearly 10 percent for the day.

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Robert A. Gregg has been appointed vice president, regulatory affairs and quality assurance at OraSure Technologies, Inc. He will have responsibility for the company's regulatory, quality assurance and clinical affairs functions.

Gregg joins OraSure with extensive experience in global regulatory affairs, including more than 25 years of relevant experience in the medical device and diagnostics industries with such organizations as Roche Diagnostics, Johnson & Johnson and the U.S. Food and Drug Administration. Since 2004, Gregg had served as vice president, corporate regulatory affairs and Quality Systems at PerkinElmer Inc., a global leader in health sciences.

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Debra Fraser-Howze, vice president of external affairs at OraSure Technologies and founder and former CEO of the National Black Leadership Committee on AIDS, has been awarded the Scroll of Merit by the National Medical Association.

The Scroll of Merit is the highest award conferred by the association and is given in recognition of unique exceptional achievement in medicine, science, education or public service.

The award was conferred on July 25 at the association's annual convention and scientific assembly in Las Vegas.

Fraser-Howze was selected because of her contributions to the fight against HIV/AIDS in the African American community. She was the first to mobilize a broad coalition of African American leaders that included clergy, political leaders, community organizations and medical professionals in the fight against HIV/AIDS at a time when many were unaware of the disease or the danger to the community.

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Debra Fraser-Howze, vice president of External Affairs at OraSure Technologies and founder and former CEO of the National Black Leadership Committee on AIDS, was honored last month by the National Medical Association (NMA) during a gathering of members of the African-American doctors organization in Las Vegas.

Fraser-Howze received the NMA's highest honor, the Scroll of Merit, for her important contributions to the fight against HIV/AIDS in the African American Community

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Debra Fraser-Howze, Vice President of External Affairs at OraSure Technologies and founder and former CEO of the National Black Leadership Committee on AIDS has been awarded the Scroll of Merit by the National Medical Association (NMA).

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Debra Fraser-Howze, vice president of external affairs at OraSure Technologies and founder and former CEO of the National Black Leadership Committee on AIDS, has been awarded the Scroll of Merit by the National Medical Association (NMA).

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Debra Fraser-Howze was awarded the Scroll of Merit by the National Medical Association. The Scroll of Merit is the highest award conferred by the NMA and is given in recognition of exceptional achievement in medicine, science, education or public service.

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Debra Fraser-Howze, vice president of external affairs at OraSure Technologies, says it is critically important that black women that are at risk for HIV/AIDS are tested to know their status.

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A citywide HIV Testing campaign that utilizes mobile text messages to link residents of Philadelphia with the locations of HIV testing sites throughout the city was launched today. Through the campaign, any city resident can send a text message with 'PA' plus their five-digit zip code to phone number (36363) and receive a free text message with information about the HIV testing location nearest to them.

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On Friday, June 26, OraSure partnered with the Philadelphia Department of Public Health AIDS Activities Coordinating Office (AACO) to kickoff Get Text-ed for HIV, a citywide HIV testing campaign to provide HIV testing site information to residents of Philadelphia via mobile text messages.

Using a mobile phone, Philadelphia residents can send a text message with their five-digit zip code and receive a free text message with HIV/AIDS testing center locations closest to them.

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On June 20th at Mansfield Motorsports Park, fans will experience more than just a day full of blood pumping, auto racing. When the ARCA RE/MAX competitors come to town, visitors to the track will help pay tribute to fallen auto racing hero and Ohio native Tim Richmond. Fans will also be invited to participate in a brand new motorsports health awareness campaign focused on HIV/AIDS awareness and testing.

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The race is a celebration of the life of Tim Richmond, but it's also raising awareness about his death.

Richmond, an Ashland native who was named one of NASCAR's 50 greatest drivers, died from AIDS 20 years ago. At the ARCA ReMax Series race named after him on Saturday, race promoter and longtime Richmond friend Joe Mattioli, along with Mansfield Motorsports Park owner Mike Dzurilla, want to do something positive in the late racer's memory.

The Ohio Department of Health as well as the Mansfield/Ontario/Richland County Health Department and the Ohio Rural AIDS Advisory Group will have a booth at the track from 2 to 6 p.m. Saturday where it will give HIV rapid tests with results in 20 minutes. There will also be brochures available at no charge.

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At the first annual Pay it Forward Health Fair in Batesville, Batesville native and two-time Superbowl champ Deshea Townsend swabs his mouth with the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test to draw attention to the critical role of HIV testing and prevention education play in stemming the spread of AIDS in Mississippi.

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Nothing awakens the activist spirit in a person like a national issue hitting close to home. For Deshea Townsend, defensive back for the Pittsburgh Steelers, the alarming rates of HIV/AIDS infections in his hometown of Batesville, Mississippi, quickly turned him from Super bowl champ to Super activist.

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In the last 30 years, we have witnessed the industry's coming of age, with its first blockbuster device and its shift from individual inventors and small start-ups to globally recognized brand names. The OraQuick Advance Rapid HIV-1/2 Antibody Test is included as one of the 30 devices over the last 30 years that have changed the industry and the world.

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The 33-year-old grew up in this small town of Batesville with three brothers and two sisters. He had two parents who made sure he went to school and teachers who made sure he did his work.

Deshea Townsend, a cornerback for the 2009 Superbowl Champions, the Pittsburgh Steelers, gives most of the credit to his teachers, his parents and a community who has supported him since he went off to college at the University of Alabama.

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Deshea Townsend, a two-time Super Bowl winner as a member of the Pittsburgh Steelers and founder of the Pay It Forward Foundation and Football Day Camp -- now in its 10th year -- on May 16 took a public oral HIV antibody test to draw attention to the impact of the disease in his home state of Mississippi and to encourage others to get screened for the disease.

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A London NHS trust has become the first in the country to offer an HIV saliva test that provides definitive results on the spot in 20 minutes. The test uses a toothbrush to pick up HIV antibody markers from the gum line. Barts and the London NHS Trust hope more people will seek testing if the need to give blood and wait perhaps up to a week for results is eliminated. Saliva tests are not new - and are indeed widely available in the US. Home saliva tests are banned in the UK because counselling is not to hand, but Barts has become the first to offer the mouth swab on the NHS and provide almost immediate results.

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OraSure Technologies continues to bet big on broadening the reach of its products, which can quickly test blood and oral fluid for HIV infection or drug use, by investing heavily in research and development.

By spending so much on getting new products to federal government approval, the Bethlehem company is sacrificing profits today in hopes of bigger returns in the future.

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You might not realize it, but one of the major problems with treating HIV is that many people don't know they have it. In the United States, it's estimated that some 1.2 million have HIV in the United States--but nearly a third of those don't know it.

That's why OraSure's novel HIV screening device, OraQuick ADVANCE®, has the potential for wide acceptance not only in the United States, but also in an international community that affects more than 40 million people worldwide.

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NBC's Robert Bazell discusses a new report issued by the Department of Health in Washington DC has set off alarm signals in the nation's capital. The report confirmed for the first time that at least 15,120 residents -- about 3,000 per every 100,000 over the age of 12 (roughly 3% of the total DC population!) -- have HIV or AIDS.

The video shows footage of the District of Columbia Department of Health's Operational Support testing van traveling to different parts of Washington DC persuading people to learn their HIV status by taking OraSure's OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test.

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Debra Fraser-Howze, OraSure's Vice President of Government and External Affairs, participated in an on-air interview with Lehigh Valley's WFMZ-TV 69 News. Ms. Fraser-Howze discussed the HIV/AIDS crisis among the African American Community and also what is being done, nationally and locally to help stem the spread of HIV/AIDS.

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On Monday, March 9, 2009, OraSure Technologies was the site of recognition event that honored Congressman Dent and the work he has done to improve healthcare for veterans, including his work in passing legislation to remove barriers to HIV Testing throughout VA Health Care System.

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As winter warms into summer, there is much more to keeping healthy than just keeping your body toned and tanned: Keep it fine-tuned by being sexually healthy this spring.

Last week, University of South Alabama observed Minority AIDS Awareness Week by offering a free Oraquick Rapid HIV testing Feb. 16 and 17 at the Student Health Center. All testing remained confidential, and results were determined within 20 minutes. Due to the testing's popularity, supplies were depleted before the second day of tests could even begin.

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More than 80% give oral sample: hospital

People waiting to be seen in the emergency room at Advocate Trinity Hospital in the Calumet Heights neighborhood don't just get forms to fill out. They're also offered a free HIV test, no matter why they're there.

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OraSure Technologies announced this week that the U.S. Food and Drug Administration has approved its request for 12-month shelf life from the date of manufacture for its OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test.

The FDA approval is based on enhancements made by OraSure to the manufacturing process and product packaging of its OraQuick ADVANCE® test, and represents a six-month increase in shelf life over that of product currently available. The company anticipates having the enhanced product available for delivery starting in March.

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Dr. Timothy Friel from Lehigh Valley Hospital's Aids Activities Office and Mr. Douglas Michels, CEO of Orasure Technologies in Bethlehem sat down with WFMZ's Eve Tannery this morning on 69 News at Sunrise to talk about where the global fight stands and what's being done in the Lehigh Valley to help.

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The first rapid oral fluid hepatitis C test for the US market, called OraQuick, may be available soon. OraSure Technologies, Inc., the test's developer, has recently filed for FDA approval. This process will probably take some time, but in the end, people with hepatitis C (especially those who aren't aware of their infection) will have a powerful test to use.

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An evaluation by the Walter Reed Army Institute of Research of the still-in-development OraQuick HCV Test found that it had higher sensitivity (99.4 percent) than and highest specificity (99.7 percent) of other hepatitis C tests evaluated.

The OraQuick HCV Test detected HCV antibodies approximately three days sooner than available laboratory-based enzyme immunoassays and approximately sixteen days earlier than the next most sensitive rapid HCV test, the evaluation indicated.

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OraSure Technologies, Inc. has announced that it has submitted an approval application to the United States Food and Drug Administration (FDA) for its rapid hepatitis C virus (HCV) test kit.

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OraSure Technologies on Tuesday announced that it has submitted a pre-market approval application to the U.S. Food and Drug Administration for its rapid test for antibodies to the hepatitis C virus utilizing OraSure Technologies OraQuick technology platform.

If approved, the OraQuick HCV test is expected to be the first rapid HCV test approved by the FDA for use in the United States.

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Our country's largest and oldest laboratory in the US Army, the Walter Reed Army Institute of Research, recently picked OraQuick as the best rapid hepatitis C test for screening blood in the field. OraQuick is a test being developed by OraSure Technologies.

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At a National Latino AIDS Awareness Day kickoff in NYC, Miss Universe Dayana Mendoza swabs her mouth with an OraQuick HIV test, the first and only FDA approved, rapid oral HIV test that provides greater than 99% accurate results in less than 20 minutes.

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Another obstacle to routine screening for HIV is about to fall, this time for the Department of Veterans Affairs, the nation's largest provider of HIV care. You may recall that in 2006, the Centers for Disease Control and Prevention issued revised recommendations for testing adults, adolescents and pregnant women for the virus that causes AIDS.

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A new test to screen blood donors for hepatitis C (HCV) is showing promise, having scored the highest against five other systems during an evaluation by Walter Reed Army Institute of Research, according to developer OraSure Technologies.

When there's a shortage of blood for transfusions on the battlefield, medics turn to the Walking Blood Bank, i.e. any available soldier. However, short of prescreening every potential donor or using other time-consuming methods, there has been no way to be sure that a donor is disease free (PDF).

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The mayor of Phoenix joined volunteers and concerned citizens in efforts to raise awareness for national HIV Testing Day on June 27. Phil Gordon held his fourth annual press conference at Higher Heights Church to educate the Valley on the importance of HIV/AIDS testing.

"No longer does an HIV test require blood or needles...but rather an oral swab," Gordon said. OraSure technologies donated 300 OraQuick antibody tests to the Arizona Department of Health.

"The test is safe, painless and accurate - it requires just a swab of oral fluid and is greater than 99 percent accurate. Results are available in 20 minutes," according to information supplied by the Mayor's Campaign Against HIV.

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About 140 employees of OraSure Technologies in Bethlehem recently participated in the 23rd annual AIDS Walk New York in New York City.

At the event, OraSure donated OraQuick ADVANCE Rapid HIV-1/2 Antibody Tests and conducted free rapid oral HIV tests in mobile testing vans throughout the day. OraQuick ADVANCE requires just a swab of oral fluid (no blood or needles) and is greater than 99 percent accurate. Results are available in 20 minutes.

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'No blood. No pain. Instant results," is how Alexandra, 22, of Chicago describes the OraQuick Advance HIV test she took in April. Because she had had unprotected sex recently, she took the test for her "peace of mind," she says. The results: Negative.

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Today, National HIV Testing Day, I am joining more than 50 other mayors nationwide in urging everyone to get tested for HIV. From Seattle to Miami to Phoenix to Dallas, we are all signing on to make a dent in the national epidemic by reducing infections at home. Lives depend on it.

This is the 14th year that the National Association of People with AIDS has carried out its nationwide effort to boost HIV/AIDS awareness, encourage regular testing, and push for early diagnosis and treatment. This is critical for the millions of Americans at risk for HIV and the even greater number who do not know they are at risk.

But it starts with the test. And private testing is now very easy. The rapid oral tests provide accurate results in about 30 minutes.

That is why I have arranged, through the National Association of People with AIDS, for 500 OraSure Technologies rapid oral tests to be donated to the Nelson-Tebedo Health Resource Center. That means at least 500 people can get an HIV test free today, on HIV Testing Day, and learn their HIV status.

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BETHLEHEM | You don't know what you don't know.

That's the logic community health specialist Kari Kirchgessner uses at the Bethlehem Health Bureau to convince people to learn their HIV status. On Friday, National HIV Testing Day, she said a dozen people found out during the bureau's annual testing drive.

Bethlehem-based OraSure Technologies donated rapid test kits—hey take about 20 minutes to process—for Friday's testing drive. Kirchgessner said most testing is done by blood draw, with results taking about two weeks.

The CDC estimates about one-third of the people who get tested by blood draw never come back for their results. OraSure's Vice President of Marketing Ron Ticho said the company is battling that statistic with its rapid test.

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BENSALEM — Every year an estimated 50 million pre-employment and post-employment drug-screening tests are administered for businesses by private laboratories in the United States.

"It's a $3 billion marketplace," said Dr. Raza Bokhari, chairman and owner of Parkway Clinical Laboratories.

Bokhari wants Parkway to become a major player in the employee drug-screening arena by having his lab promote oral fluid drug screening over the traditional method of testing urine samples for substance abuse.

Parkway is one of just a handful of labs in the country to be certified by OraSure Technologies, Inc. of Bethlehem, Pa., to test saliva samples for substance abuse using OraSure's Intercept oral fluid collection device.

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At a downtown facility near skid row, the VA can swab a person's mouth and get almost instant results.

The VA Greater Los Angeles Healthcare System began offering 20-minute HIV tests at its downtown ambulatory care center Tuesday -- part of a campaign to encourage more veterans to get tested and treated for the virus.

"HIV testing is the gateway to life-saving therapy," said Dr. Earl Tso, a primary care physician who is leading the downtown center's outreach effort.

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Three distinguished Atlantans sat at a table in front of TV cameras and a flock of churchgoers Sunday afternoon and swabbed the insides of their mouths for all to see.

Sunday marked the 19th annual National Black Church Week of Prayer for the Healing of AIDS. The testing at Ebenezer was conducted in collaboration with the National Black Leadership Commission on AIDS, AID Atlanta and Our Common Welfare.

Warnock, Bond and Lewis submitted to an OraQuick ADVANCE test, described as the only rapid saliva test for HIV.

No needles are used and no blood is drawn, and results can be obtained in less than 20 minutes. That is significant, representatives said, because many people tested for HIV at public health clinics never return to learn the results.

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NASHVILLE, Tenn. — As part of a new pilot program, anyone that is rushed to the Vanderbilt Emergency room will now automatically be tested for HIV. People that come in to the ER for medical treatment will automatically have their mouth swabbed as part of the free test, unless they opt out of the procedure. The Centers for Disease Control and Prevention is funding the new six-month program to detect HIV infections earlier and get more people follow-up with care. People who are brought into the ER in a disoriented state are automatically waived from the test.

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You've read all of the scary statistics. You've watched the commercials, You've driven by the huge billboards. So why are you still getting infected?

Getting tested is easier than it's ever been. OraQuick Advance has developed a way to know your status in 20 minutes through the OraSure test, through the only rapid oral fluid (saliva) HIV test. No needles, no blood, no waiting. This is significant because prior to the introduction or rapid testing, more than one-third of the 2.2 million Americans tested for HIV at public health clinics each year did not return to learn their test results—as many as 8,000 individuals who test positive for HIV each year do not return for their results.

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OraSure Technologies Inc, Bethlehem, Pa, announced that Debra Fraser-Howze, current President/CEO of the National Black Leadership Commission on AIDS (NBLCA), has joined the company as vice president, government and external affairs.

Fraser-Howze will represent the company with government officials regarding the issues, policies, and laws impacting the company's businesses, including the infectious disease and substance abuse testing businesses.

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Obama urged unity despite political differences to fight the disease that has killed 25 million people since the first case was reported in 1981. Some 40 million currently are infected with HIV, the virus that causes AIDS.

"We are all sick because of AIDS," Obama said. "We are all challenged by this crisis."

In a show of political unity, Obama took an AIDS test with a potential White House rival on the Republican side—Sen. Sam Brownback of Kansas.

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