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FDA clarifies guidelines for antibody tests to combat fraudulent claims

The FDA has revised their policy on antibody testing approval to try to combat what they see as fraudulent and illicit claims made by some commercial entities about the FDA-approval status and effectiveness of their assays.

It seems that the previous strategies the FDA employed to allow rapid development and dissemination of testing procedures, trying to overcome the lag in effective testing in this country, produced some unintended consequences of allowing some poorly performing tests to be used, and especially problematic is the inaccurate way they are being marketed in terms of their FDA approval process.

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