 | This article may have been created or edited in return for undisclosed payments, a violation of Misplaced Pages's terms of use. It may require cleanup to comply with Misplaced Pages's content policies, particularly neutral point of view. (December 2020) |
 | This section needs expansion. You can help by adding to it. (July 2020) |
| Company type | Public |
|---|---|
| Traded as | Nasdaq: OSUR |
| Industry | Medical Devices |
| Headquarters | Bethlehem, Pennsylvania, U.S. |
| Area served | Worldwide |
| Products | OraQuick |
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.
References
- ^ "FDA approves first take home HIV test kit". The Hindu. 2012-07-04. ISSN 0971-751X. Retrieved 2020-10-09.
- ^ McNeil Jr, Donald (2012-07-03). "Rapid H.I.V. Home Test Wins Federal Approval (Published 2012)". The New York Times. ISSN 0362-4331. Retrieved 2020-10-09.
- McNeil Jr, Donald (2012-10-05). "Another Use for Rapid Home H.I.V. Test: Screening Sexual Partners (Published 2012)". The New York Times. ISSN 0362-4331. Retrieved 2020-10-09.
- ^ "Home Testing for HIV -- Reading the Lines in Do-It-Yourself Test". ABC News. Retrieved 2020-10-09.
- ^ Kennedy, Sam (16 May 2004). "Founder trading OraSure for new career, family time ** Sam Niedbala started business with partners in '88. Now, he'll teach". mcall.com. Retrieved 2020-10-09.
- ^ Harris, Jon (11 August 2020). "In race for coronavirus test, OraSure to expand, create 177 jobs in Bethlehem as it works to bring 'lab on a swab' to market". The Morning Call. Retrieved 2020-10-09.
- ^ "FDA reviews first rapid, take-home HIV test". khou.com. 11 May 2012. Retrieved 2020-10-09.
- ""OraQuick Ebola Rapid Antigen Test"". ebola-cases.com.