OSUR - OraSure issued amended authorization by FDA for COVID-19 rapid test

OraSure Technologies (NASDAQ:OSUR) has gained ~9.0% in the pre-market after the company said that the FDA amended the previous Emergency Use Authorizations (EUA) issued for its InteliSwab COVID-19 rapid tests allowing it for single-use, at-home testing for symptomatic patients. Accordingly, the individuals with COVID-19 symptoms will only require to undergo one InteliSwab test.  Previously, the FDA issued the EUA for the at-home test irrespective of symptoms when tested twice with at least 24 hours but not more than 36 hours between tests (serial testing). However, asymptomatic people will still be required to perform serial testing if the first test generates a negative result. “FDA decision benefitting symptomatic for COVID-19 “will help increase our nationwide availability of tests, ensuring people who want rapid tests have access to them,” CEO Stephen Tang remarked.

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OraSure issued amended authorization by FDA for COVID-19 rapid test