23andMe Seeks FDA Clearance (Podcast)

Last week, personal genetics company 23andMe announced that it had formally delivered the first round of documentation to the U.S. Food and Drug Administration (FDA) in an attempt to receive 510(k) clearance for its consumer product.

23andMe declared itself “first in the [ direct-to-consumer (DTC) genetic testing] industry to announce it is working towards FDA clearance.” That first followed another first for the company earlier in the summer: 23andMe’s first patent, which covers a method of predicting susceptibility to Parkinson’s Disease.

I sat down last week with The Burrill Report to discuss 23andMe’s recent activities and their implications for the future of DTC genetic testing and personalized medicine. You can listen to the complete podcast here.

Filed under: Direct-to-Consumer Services, FDA LDT Regulation, General Interest, Genetic Testing/Screening, Genomics & Medicine, Genomics & Society, Industry News, Legal & Regulatory, Patents & IP, Pending Regulation
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