OraSure Technologies

OraSure Technologies
Traded as
Nasdaq: OSUR
S&P 600 Component
IndustryMedical Devices
Headquarters
Bethlehem, Pennsylvania
,
United States
Area served
Worldwide
ProductsOraQuick

OraSure Technologies 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

  1. 1 2 3 "FDA approves first take home HIV test kit". The Hindu. 2012-07-04. ISSN 0971-751X. Retrieved 2020-10-09.
  2. 1 2 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.
  3. ↑ 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.
  4. 1 2 "Home Testing for HIV -- Reading the Lines in Do-It-Yourself Test". ABC News. Retrieved 2020-10-09.
  5. 1 2 3 4 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.
  6. 1 2 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.
  7. 1 2 3 "FDA reviews first rapid, take-home HIV test". khou.com. Retrieved 2020-10-09.
  8. ↑ ""OraQuick Ebola Rapid Antigen Test"". ebola-cases.com.
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