FDA to allow states to authorize coronavirus tests

Aimed at ramping up testing capacity in the U.S., the FDA will now allow individual states to authorize the use of laboratory-developed tests by qualified in-state labs for the coronavirus causing the current outbreak. The labs do not have to engage with the FDA nor will they need to apply for Emergency Use Authorization (EUA).

Although states are not required to follow New York’s lead, the Empire State’s system may serve as a useful guide for others.

The FDA will also allow the distribution of commercially developed tests prior to Emergency Use Authorization under certain circumstances and only after the tests have been validated. The agency believes that a 15-period should be sufficient to prepare an EUA filing.

The agency will also allow the distribution of serology tests (tests that detect SARS-CoV-2 antibodies in the blood) contingent on the tests being validated, the FDA being notified and the inclusion of warnings that the tests have not been reviewed by the FDA and results should not be the sole basis for diagnosing or excluding COVID-19.

The FDA says more than 90 test developers have sought its assistance thus far.

COVID-19 test-related tickers and after-hours movement: Co-Diagnostics (NASDAQ:CODX) (+2%), Luminex (NASDAQ:LMNX), OPKO Health (NASDAQ:OPK) (+5%), Chembio Diagnostics (NASDAQ:CEMI), Aytu BioScience (NASDAQ:AYTU) (+3%), Thermo Fisher Scientific (NYSE:TMO) (+7%), Abbott (NYSE:ABT) (+3%), Becton, Dickinson (NYSE:BDX), Roche (OTCQX:RHHBY), LabCorp (NYSE:LH) (+4%), Quest Diagnostics (NYSE:DGX) (+1%)

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