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

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.

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.

➤ FDA letter (Via Bloomberg)

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