OraSure Technologies is a

Bethlehem, Pennsylvania Bethlehem is a city in Northampton and Lehigh Counties in the Lehigh Valley region of eastern Pennsylvania, United States. As of the 2020 census, Bethlehem had a total population of 75,781. Of this, 55,639 were in Northampton County and 19, ...

based company in the medical device industry. Their products include diagnostic testing kits. The company had recently developed

OraQuick OraQuick is an at-home HIV test manufactured by OraSure Technologies, Orasure Technologies that was approved by the United States Food and Drug Administration in 2012. It is one of only two at-home HIV tests available. OraQuick can be purchased b ...

testing kit, the first over-the-counter home

HIV The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...

test.

History

OraSure was founded in 1988 by Sam Niedbala, Mike Gausling and two others as SolarCare Technologies Corp. In 2000, the company merged with Epitope, a company that had developed a way of testing for HIV. After the merger, the company became OraSure. In 2004, founder Sam Niedbala retired from the company. In response to the

COVID-19 pandemic The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identif ...

, OraSure expanded the company by creating over 150 jobs in Bethlehem to work on creating a rapid, at-home coronavirus test. The company had previously developed products to rapidly check for Hepatitis C and Ebola.

Products

OraSure created the OraQuick test, which can detect the presence of HIV from a mouth swab within 20 minutes. In 2004, the company began marketing OraQuick to health care practitioners. 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. The test was more accurate at clearing patients who didn't have the disease, correctly identifying HIV-negative users 99 percent of the time. In July 2012, OraQuick was approved by the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

for over-the-counter use. 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.

References

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External links

OraSure Technologies website
Pharmaceutical companies of the United States Health care companies based in Pennsylvania Companies based in Northampton County, Pennsylvania Companies listed on the Nasdaq