23andMe Challenges a Creaky Regulatory State
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Dec. 5 (Bloomberg) -- Let’s agree that 23andMe Inc., theGoogle-backed company marketing a $99 genetics test thatassesses your risk for more than 240 health conditions, didn’tmanage its relationship with the Food and Drug Administrationwell.
After “more than 14 face-to-face and teleconferencemeetings, hundreds of email exchanges, and dozens of writtencommunications,” the FDA wrote in a letter to 23andMe, “youhave not worked with us toward de novo classification, did notprovide the additional information we requested necessary tocomplete review of your 510(k)s, and FDA has not received anycommunication from 23andMe since May.”