23andMe relaunches genome service in U.S.

23andMe Inc. (Mountain View, Calif.) relaunched its Personal Genome Service (PGS) in the U.S. with carrier tests included in the product. The company had 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.

The service includes carrier tests for 36 conditions including cystic fibrosis and sickle cell anemia. 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 (see BioCentury Extra, Feb. 20). ...