WASHINGTON (AP) — The Food and Drug Administration is ordering genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is backed by science.
In a warning letter posted online, FDA regulators say the Silicon Valley company is violating federal law because its products claim to identify health risks for more than 250 diseases and health conditions.
Only medical tests that have been cleared by the FDA are permitted to make such claims.
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A call was placed and an email was sent seeking comment from the company.
The warning letter follows years of back-and-forth between the government and companies that market products claiming to predict inheritable diseases. Public health officials and doctors worry that many genetics tests are built on flimsy science.
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