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FDA stops 23andMe from selling genetic kits

The Food and Drug Administration issued a warning letter to 23andMe CEO Ann Wojcicki on Friday, saying the company was selling its spit kits and Personal Genome Service without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).

The direct-to-consumer personalized genomics test is “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease,” FDA contends, citing language on the 23andMe website heralding the service as the “first step in prevention”.

FDA specifically highlighted concerns about 23andMe’s assessment for BRCA-related genetic risk and drug responses. “For instance,” FDA wrote, “if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.”
BioIT World