FDA steps up scrutiny of virus antibody tests after criticism for sending them to market without review
The Food and Drug Administration, under fire for allowing more than 100 commercial coronavirus antibody tests on the market without review, moved Monday to assert oversight, saying the tests will have to pass agency muster, including meeting standards for quality and accuracy.
Officials said “unscrupulous actors” have been “marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.”
The FDA action came after the agency was criticized for a March 16 policy that allowed commercial test makers to sell antibody tests after validating their own data and notifying the FDA. The result, some testing experts said, was a flood of products of dubious quality that confused hospitals, doctors and consumers — “a wild, wild West” environment, said Scott Becker, executive director of the Association of Public Health Laboratories, which represents state and local public laboratories.
http://www.washingtonpost.com/nation/2020/05/04/coronavirus-update-us/#link-LOJCV5NVMFCUHD3TZCESNIJMUM
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