It looks as though the FDA is swooping down on the direct-to-consumer genetic testing industry in a serious way, sending formal letters to five companies informing them that their tests will be regulated as medical devices:
WASHINGTON — The Food and Drug Administration is issuing regulatory letters to five genetic test makers, the first sign that the government is cracking down on companies that claim to use DNA samples to predict inheritable diseases.
The FDA letters notify each company that their tests are considered medical devices and therefore must be federally approved as safe and effective. None of the companies have submitted their products for approval, according to the FDA.
The letters posted online deal with specific tests marketed by: 23andMe Inc., deCODE Genetics, Illumina, Navigenics and Knome Inc.
FDA asks each of the companies to contact the agency to make arrangements for submitting their tests for review.
23andMe has never submitted information on the analytical or clinical validity of its tests to
FDA for clearance or approval. However, your website states that the 23andMe Personal
Genome Service™is intended to tell patients in advance how they will respond to certain
medications including warfarin and clopidogrel. It also states that the data generated from the 23andMe Odds Calculator, a feature ofthe 23andMe Personal Genome Service™, includes the contribution of single-nucleotide polymorphisms (SNPs) to disease risk. Consumers may make medical decisions in reliance on this information.