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


Benzinga | Jun 7, 2021 10:38AM EDT

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

* OraSure Technologies Inc (NASDAQ: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.







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