Home 5 Clinical Diagnostics Insider 5 23andMe’s Approval Marks ‘Baby Step’ in DTC

23andMe’s Approval Marks ‘Baby Step’ in DTC

by | Apr 10, 2015 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, DTC-dtet

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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