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OraSure Technologies, Inc.

http://www.orasure.com

Latest From OraSure Technologies, Inc.

FDA Revokes Emergency Authorization On Ebola, Zika Tests

Emergency Use Authorizations on two Ebola tests and one for the Zika virus have been revoked by the US agency because it cleared the tests via more permanent pathways.

Diagnostics Review Pathway

Global Approvals Snapshot: October 2019

October’s approvals include the US FDA approval of Myriad’s myChoice CDx companion diagnostic for GlaxoSmithKline’s ovarian cancer drug and the approval or Medtronic’s Valiant Navion thoracic stent graft system in Japan.

Approvals Innovation

World AIDS Day 2016: HIV Self-Testing Gets Boost From New WHO Guidelines

To mark this year's World AIDS Day on Dec. 1, the World Health Organization has expanded its guidelines on HIV testing that will help increase the uptake of HIV self-testing – and a likely boost for manufacturers of these products – and improve HIV partner notification services.

In Vitro Diagnostics Policy

OTC Tests For Flu, Strep, STIs Up For Discussion At FDA Panel Meeting

Panelists will look at the benefits and risks of over-the-counter diagnostics for influenza, strep throat and sexually transmitted infections. The meeting is being held in response to sponsor queries about new test designs.

In Vitro Diagnostics Regulation
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Company Information

  • Industry
  • Biotechnology
  • Distributors
  • Services
  • Medical Devices
    • Diagnostic Imaging Equipment & Supplies
      • Molecular Imaging
  • In Vitro Diagnostics
    • Chemistry, Immunoassay
    • Therapeutic Drug Monitoring
    • Urine-based Testing
  • Other Names / Subsidiaries
    • Corebiome
    • Diversigen
    • DNA Genotek
    • Novosanis
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