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OraSure Technologies
Medical device company From Wikipedia, the free encyclopedia
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OraSure Technologies, Inc. is a Bethlehem, Pennsylvania–based company in the medical device industry. Their products include diagnostic testing kits. The company had recently developed OraQuick testing kit, the first over-the-counter home HIV test.[1][2][3][4]
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History
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OraSure was founded in 1988 by Sam Niedbala, Mike Gausling and two others as SolarCare Technologies Corp.[5]
In 2000, the company merged with Epitope, a company that had developed a way of testing for HIV.[5] After the merger, the company became OraSure.[5]
In 2004, founder Sam Niedbala retired from the company.[5]
In response to the COVID-19 pandemic, OraSure expanded the company by creating over 150 jobs in Bethlehem to work on creating a rapid, at-home coronavirus test.[6] The company had previously developed products to rapidly check for Hepatitis C and Ebola.[6]
Products
OraSure created the OraQuick test, which can detect the presence of HIV from a mouth swab within 20 minutes.[1] In 2004, the company began marketing OraQuick to health care practitioners.[7]
In a trial by OraSure, the test correctly detected HIV in those carrying the disease 93 percent of the time, a rate below the FDA-recommended 95 percent threshold for accuracy.[7] The test was more accurate at clearing patients who didn't have the disease, correctly identifying HIV-negative users 99 percent of the time.[7]
In July 2012, OraQuick was approved by the Food and Drug Administration for over-the-counter use.[1][2][4]
There is also an OraQuick test for Ebola. The test is a rapid-antigen test that can be used on both live patients and cadavers.[8]
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