FDA to regulate genetic tests as medical devices

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.

Depending on the details, this may be disastrous for the nascent personal genomics industry and its customers - excessive regulation would negatively impact on innovation in the field by increasing the barrier to entry for new products, as well as increasing costs for consumers.It's also worth noting that there's no real evidence that FDA regulation would have prevented the sample mix-up by 23andMe last week. As Dan Vorhaus noted in an excellent post on the incident, this mistake had nothing to do with the first-to-consumer nature of 23andMe's product; it's a problem that could have occurred to any genetic testing company. So the FDA's singling out of direct-to-consumer testing companies and their providers looks to be driven more by publicity than by a genuine desire to protect test consumers.For more as this story evolves, keep an eye on this blog and Genomics Law Report.Update: the letters are all available here (thanks to Dan Vorhaus). Here's an excerpt from the letter to 23andMe:> 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.