OraSure Technologies

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OraSure Technologies, Inc.
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.^[1]^[2]^[3]^[4]

History

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]

References

^ ^a ^b ^c "FDA approves first take home HIV test kit". The Hindu. 2012-07-04. ISSN 0971-751X. Retrieved 2020-10-09.
^ ^a ^b 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.
^ ^a ^b "Home Testing for HIV -- Reading the Lines in Do-It-Yourself Test". ABC News. Retrieved 2020-10-09.
^ ^a ^b ^c ^d 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.
^ ^a ^b 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.
^ ^a ^b ^c "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.

External links

OraSure Technologies website

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