Regulator sends warning letters to companies over direct-to-consumer genetic tests.

The FDA is beginning a crack down on companies selling genetic tests without the proper approval. DNA4Life and Interleukin Genetics are among the companies experiencing push back from the regulator, who sent a similar warning to Pathway Genomics over the marketing of a liquid biopsy DNA test in September. 

These letters come in the wake of 23andMe’s two-year battle with the regulator over its direct-to-consumer personal DNA tests. After being ordered off the market in 2013, 23andMe finally re-launched their service in February. The company’s current offering focusses on carrier screening, tests that can identify whether an individual carries genes associated with 36 different heritable disorders. 

Alabama-based DNA4Life offer a Pharmacogenetic Report, which for $249 will predict how patients will respond to commonly prescribed medication. According to the FDA letter the Pharmacogenetic Report qualifies as a medical device, and as such requires clearance. DNA4Life have yet to comment on the letter, but explained to Reuters that it did not believe that FDA approval was needed for the test. Interleukin Genetics and DNA-CardioCheck have come in for similar scrutiny, for tests designed to identify genetic disposition to a range of health conditions. 

The DTC marketplace has experienced a flurry of activity recently, as many companies are looking to take advantage of the FDA’s renewed goodwill towards 23andMe and the DTC model. With the advent of Illumina’s Helix in the marketplace, there is little doubt that genomics is set to become a mainstream consumer product. 

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