(See the New York Times story, where Duke professor Misha Angrist said at least some of the FDA's claims were "borderline absurd." While in contrast, a Forbes columnist called 23andMe's tactics "the dumbest regulatory strategy" he'd ever heard of.)
The company wrote on its blog on November 25, "We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission..." By December 5, the company stopped releasing any healthcare-related information in its customer reports, although the 23andMe genetic profile is still available as raw information, with ancestry information, for $99.
What's new in April 2014?
In the last month, all sorts of news about 23andMe has been popping up, although not directly on the FDA issue. (The company is still working on that, but it's behind the scenes.) What we do know is that 23andMe has been on a hiring roll. For example:
- Kathy Hibbs, a well-known life sciences attorney and general counsel at Genomic Health (a leading medical genomics company with a $830M market cap) has joined 23andMe as general counsel and chief regulatory officer.
- Jill Hagenkord has been hired away from SF-based genomics startup In Vitae to be Chief Medical Officer of 23andMe.
BioIT World just featured 23andMe in a major late March story, "23andMe Pursues Health Research in the Shadow of the FDA." (Take that, FDA...) This detailed report focuses on an interview with Joyce Tung, who is 23andMe's Director of Research. Leveraging 23andMe data, Tung was senior author on a 2013 paper in the prestigious journal Nature Genetics on allergy loci.
With the new hires -- and we can assume this talent pool is not stupid -- it will be exciting to see what happens at 23andMe over the next year.
(For another celebrity hire as Chief Medical Officer in a genomics company, former NCI head Richard Klausner MD was snapped up by Illumina).