OraSure Technologies explained

OraSure Technologies, Inc.
Type:Public
Traded As:NASDAQ:
Location City:Bethlehem, Pennsylvania
Location Country:U.S.
Area Served:Worldwide
Industry:Medical Devices
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. 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.[6] 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.[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. 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.[8]

External links

Notes and References

  1. News: 2012-07-04. FDA approves first take home HIV test kit. en-IN. The Hindu. 2020-10-09. 0971-751X.
  2. News: McNeil Jr. Donald. 2012-07-03. Rapid H.I.V. Home Test Wins Federal Approval (Published 2012). en-US. The New York Times. 2020-10-09. 0362-4331.
  3. News: McNeil Jr. Donald. 2012-10-05. Another Use for Rapid Home H.I.V. Test: Screening Sexual Partners (Published 2012). en-US. The New York Times. 2020-10-09. 0362-4331.
  4. Web site: Home Testing for HIV -- Reading the Lines in Do-It-Yourself Test. 2020-10-09. ABC News. en.
  5. Web site: 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.. 2020-10-09. mcall.com. en-US.
  6. Web site: 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. 2020-10-09. The Morning Call.
  7. Web site: FDA reviews first rapid, take-home HIV test. 2020-10-09. khou.com. 11 May 2012 . en-US.
  8. Web site: "OraQuick Ebola Rapid Antigen Test" . ebola-cases.com.