Be its product (Personal Genome Services “PGS”) an information service, or a healthcare device; be the FDA’s regulatory jurisdiction crystal clear or murky debatable, 23andMe has been short of responsible by not communicating with the agency for 6 months.
That didn’t take long. Quite literally about 5 days from the date of the FDA’s warning letter to 23andMe (11/22 – here) and the filing of a class action law suit in the Southern District Court of California (11/27 – here).
While the merits of the legal case are best suited for legal interpretation and debate, the damage to the marketing of general purpose Personal Genome Services (by 23andMe or any other company) could be significant. As stated in the filing:
“NATURE OF THE ACTION”
1. This proposed class action alleges that 23andMe, Inc. (“Defendant”) falsely and misleadingly advertises their Saliva Collection Kit/Personal Genome Service (“PGS”) as providing “health reports on 240+ conditions and traits”, “drug response”, “carrier status”, among other things, when there is no analytical or clinical validation for the PGS for its advertised uses.
2. In addition, Defendant uses the information it collects from the DNA tests consumers pay to take to generate databases and statistical information that it then markets to other sources and the scientific community in general, even though the test results are meaningless. Read more »