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March 16, 2015.
23andMe has announced that it is launching a new drug discovery and development division using the human genetic data the company has collected. 23andMe’s research platform is, according to a statement, the “world’s largest consented, re-contactable database.” The new business unit will be led by Richard Scheller, PhD, who was formerly the executive vice-president of research and early development at Genentech. Dr. Scheller will be in charge of recruiting scientists and researchers for the division beginning in April 2015.
The Google-supported company had previously entered into deals with Pfizer and Genentech, allowing the companies to use the information in their customer-submitted repository of information. Prior to the announcement, it had also been selling genetic tests directly to consumers.
In 2013, FDA told the company, in a warning letter, that it could not market the “23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).” FDA said in 2013 that 23andMe had not even started other studies necessary to support a marketing submission for the PGS and had even initiated new marketing campaigns that would imply the company planned to expand PGS' uses without authorization. In February 2015, however, FDA issued a releasegranting permission to 12andMe to market a specific test to consumers for Bloom Syndrome, a rare disorder. Because the test was a “autosomal recessive carrier screening test” meant to inform the user of his or her carrier status, “the FDA determined that 23andMe’s submission did not have an applicable predicate device, and converted it to a de novo request,” according to a 23andMe press release, meaning that this type of test would be exempt from FDA premarket review. As Forbes’ Robert Hof notes, it’s not yet clear if 23andMe will still be able to offer whole genome sequencing kits, however.