OraSure's COVID-19 Rapid Antigen Tests Gets FDA Emergency Approval for OTC, Professional, Prescription Use

  • OraSure Technologies Inc OSUR has received FDA Emergency Use Authorization (EUA) for its COVID-19 rapid antigen tests, InteliSwab.
  • These tests detect active COVID-19 infection; the agency has given the emergency nod for Over-the-Counter use.
  • FDA has also authorized the InteliSwab COVID-19 Rapid Test Pro for professional use in point of care (POC) and InteliSwab COVID-19 Rapid Test Rx for Prescription Home Use.
  • InteliSwab incorporates a built-in swab that is fully integrated into the test stick, simplifying the entire testing process.
  • The use of the integrated swab also helps ensure supply continuity, as InteliSwab does not require sourcing scarce nasal swabs.
  • The testing result is available on the test stick in 30 minutes.
  • The Company will be ramping up the production capacity to 70 million units annually from the current 55 million in Q3 of 2021.
  • Price Action: OSUR shares are up 4.6% at $9.72 during the market session on the last check Monday.
Posted In: BriefsCovid-19NewsHealth CareSmall CapFDAGeneral