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FDA Sped Up Virus Tests. Next Came Fraud

Feds will tighten scrutiny because of 'fraudulent' kits on the market
By Newser Editors and Wire Services
Posted May 4, 2020 3:14 PM CDT

(Newser) – US regulators on Monday pulled back a decision that allowed scores of coronavirus blood tests to hit the market without first providing proof that they worked, per the AP. The Food and Drug Administration said it took the action because some sellers have made false claims about the tests and their accuracy. Companies will now have to show their tests work or have them pulled from the market. Under pressure to increase testing options, the FDA in March essentially allowed companies to begin selling tests as long as they notified the agency of their plans and provided disclaimers, including that they were not FDA approved. The policy was intended to allow "flexibility" needed to quickly ramp up production, officials said, and about 160 tests have been launched in the US.

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"However, flexibility never meant we would allow fraud," said FDA Deputy Commissioner Dr. Anand Shah. Blood tests are different from the nasal swab tests currently used to diagnose active COVID-19 infections. Instead, the tests look for blood proteins called antibodies, which the body produces days or weeks after fighting an infection. Most use a finger-prick of blood on a test strip. The revised policy follows weeks of criticism from doctors, lab specialists, and members of Congress who said the FDA’s lack of oversight created a Wild West of unregulated tests. So far, the FDA has granted authorization to 11 antibody tests. The other companies with test kits currently on the market will now be required to submit formal applications to regulators within 10 business days. (The FDA has approved the use of the drug remdesivir, which seems to speed up recovery.)


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