The FDA will regulate certain types of diagnostic tests the same way the agency monitors medical devices. Genetic testing companies deCODE Genetics, Illumina, Knome, Navigenics, and 23andMe all received letters from regulators last week informing them that, since their tests make health claims, they must be submitted for approval. Genetic test makers have thus far operated with very little agency oversight.
FDA official Alberto Gutierrez said that while the tests started out as a tool for consumers to learn about their ancestry, companies are now making claims that their services can predict how a person will respond to a drug, or how likely a user is to develop certain diseases. Test makers "began slowly making claims that we would consider high-risk, more medical-device-type claims," explains Gutierrez. "The ones we're worried about are those that say something about drug metabolism or those that define risks for major diseases." He added that all cancer test should be classified as high-risk, Class III devices. The agency is concerned that consumers will make medical decisions based on data that hasn't been tested for accuracy.
The test makers, of course, aren't pleased by the move. In a statement 23andMe said it "carefully explain[s] to our customers that the data we provide is informational and educational." 23andMe offers a test that looks for DNA sequences linked with a number of diseases, notes the Washington Post, while Navigenics claims to tell consumers how they'll respond to anticoagulant drugs warfarin and clopidogrel. Illumina markets a gene-scanning chip used by deCode and Navigenics.