FDA Authorizes OraSure's COVID-19 Rapid Tests For OTC Single-Use
- The FDA has amended OraSure Technologies Inc's (NASDAQ: OSUR) Emergency Use Authorization (EUA) for its InteliSwab COVID-19 rapid tests to only require one test for symptoms of COVID-19.
- Related Link: OraSure Wins $109M Contract To Increase COVID-19 Test Manufacturing Capacity.
- Previously, the at-home test was authorized for OTC use in people with or without symptoms when tested twice with at least 24 hours but not more than 36 hours between tests (serial testing).
- Now, people with symptoms only need to test once; people without symptoms should still perform serial testing if they get a negative result on their first test.
- In addition, OraSure conducted studies using live SARS-CoV-2 virus at independent laboratories, detecting all variants of concern, including the Delta variant.
- The FDA reviewed the data and indicated that the data was adequate and that no further data were required.
- Related: OraSure Secures $205M Contract For OTC COVID-19 Tests.
- Price Action: OSUR shares are down 1.91% at $10.80 during the market session on the last check Tuesday.
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