OraSure Technologies

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.

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, 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 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.