23andMe told to ‘immediately’ stop selling its DNA-testing kits until they are approved by the FDA

23andMe told to ‘immediately’ stop selling its DNA-testing kits until they are approved by ...

23andMe has been told by the US Food and Drug Administration (FDA) to stop selling its DNA-testing kits and Personal Genome Service (PGS).

The Google-backed startup has been selling its Saliva Collection Kit and DNA analysis service “without marketing clearance or approval” by the FDA, according to a letter sent out last Friday.

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23andMe has been selling its kits for over five years, but the FDA says it’s concerned that users could undergo unnecessary or inappropriate treatment due to a false positive or false negative reading. The startup now has fifteen days to take rectify the situation, or it could face regulatory action from the FDA.

➀ FDA letter (Via Bloomberg)

Featured image credit: Shutterstock

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