FDA moves to boost coronavirus testing capacity by giving states more power
In response to a dire shortage of tests for detecting the fast-moving coronavirus, the Food and Drug Administration is giving states new powers to authorize laboratories to develop their own diagnostic. And the FDA also approved new tests that will be distributed by LabCorp (LH) and Hologic (HOLX), two of the largest manufacturers.
The agency will allow states to take responsibility for tests developed and used by laboratories within their borders, a step that is similar to what the FDA last week granted to the New York State Department of Health. The labs will not have to pursue Emergency Use Authorization from the agency, an emergency clearance that is normally required.
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