23andMe sales and marketing update

23andMe relaunched its Personal Genome Service (PGS) in the U.S. with carrier tests included in the product. The company discontinued consumer access to its health-related genetic testing in December 2013 after it received a warning letter from FDA that said 23andMe was marketing the service “for medical device uses” for which it did not have FDA clearance or approval. 23andMe also raised the price of the service from $99 to $199. The service includes carrier tests for 36 conditions including cystic fibrosis and sickle cell anemia, but does not currently include reports on disease risks or drug-interaction risks (see BioCentury, Dec. 9, 2013).

In February, FDA granted approval for 23andMe’s Bloom syndrome carrier test and said subsequent autosomal recessive carrier screening tests would be exempt from premarket review. 23andMe launched its PGS in the U.K in December 2014, noting that “many of the drug responses, inherited conditions and genetic health risks that were of concern in the U.S. have been removed” from the U.K. product (see BioCentury, Dec. 8, 2014 & Feb. 23, 2015). ...