23andMe’s Approval Marks ‘Baby Step’ in DTC
While personal genetics company 23andMe (Mountain View, Calif.) was granted authority by the U.S. Food and Drug Administration (FDA) in late February to market the first direct-to-consumer (DTC) genetic test, experts say this does not mark a return to business-as-usual for the company. Rather, this approval marks a “baby step” in establishing a pathway for DTC testing to receive a regulatory nod and is notable for the FDA’s classification of carrier status testing as a class II device with low to moderate risk, exempting them from premarket review. The approval of the carrier test for Bloom Syndrome, a rare, autosomal recessive disorder, comes just 15 months after 23andMe received an FDA warning letter calling for discontinuation of marketing of the company’s Personal Genome Service (PGS) due to a lack of submitted evidence of the service’s safety and evidence. Unlike PGS, a comprehensive DTC genetic assessment of 254 diseases and conditions, the Bloom Syndrome Carrier Status test is very limited in scope and results are very clear-cut. “These DTC panels have not been very predictive for common diseases,” explains A. Cecile Janssens, Ph.D., Emory University (Atlanta). “The problem is in genes like BRCA 1/2, where thousands of mutations have been documented, […]
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