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FDA to Regulate Prenatal Tests

New regulations are in the works as the FDA seeks to address issues with concerns over false positives.

Daniel Reche
Daniel Reche via Pexels

A recent New York Times article said the FDA plans to regulate the prenatal testing market amid concerns about false positive results and potentially misleading marketing. The regulations would target noninvasive prenatal tests that use a small blood sample to screen for genetic abnormalities during the first trimester. While these tests are accurate for common genetic disorders like Down syndrome, they often provide incorrect positive results for rare abnormalities. 

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