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FDA Issues Warning Letters to Direct-To-Consumer Genetic Test Manufacturers


The Food and Drug Administration (FDA) has sent warning letters to direct-to-consumer genetic testing companies – including DNA4Life and Interleukin Genetics – for selling the tests without the necessary agency approval. The crackdown comes just a few weeks after the FDA gave the all-clear to fellow genetic testing service, 23andMe.

The agency cited DNA4Life for selling the company’s Pharmacogenetic Report without FDA clearance, despite the fact that the testing tool is classified as a medical device. The Pharmacogenetic Report – which costs $249 – uses a patient’s DNA to determine how their body might respond to 120 of the most frequently prescribed medications.

According to the FDA warning letter, the agency said they have “been unable to identify any FDA clearance number” for DNA4Life’s product. Though the personal genetics company has not yet commented on the letter, in an earlier interview they did comment that they did not think they needed FDA approval in order to market the test.

Interleukin Genetics and DNA-Cardiocheck were also reprimanded by the FDA. Interleukin Genetics markets tests that can identify if an individual has a genetic predisposition to obesity, diabetes and heart attack.

As was the case with DNA4Life, the FDA said they could not find clearance numbers for Interleukin Genetics’ tests. They also cited an earlier letter from the genetic testing company which stated that its products were “laboratory developed tests.” The FDA pointed out the contrary was true, saying, “It appears that at the present time, your firm is offering these tests under a direct-to-consumer model.”

DNA-Cardiocheck is also facing FDA scrutiny over its direct-to-consumer test which claims to be able to identify genetic markers associated with stroke and heart disease. The FDA has requested the company provide its clearance number for the device or be prepared to show evidence as to why the test doesn’t require approval.

The warning letters come as more companies are popping up and offering direct-to-consumer genetic tests. Earlier this year, 23andMe received FDA approval for its genetic test for carriers of Bloom syndrome, which opened the doors for other companies to market similar tests.

The California-based company recently launched its $199 test which encompasses over 60 health, ancestry, wellness and personal genetics in its reports. 23andMe’s FDA approval came as a relief to the company, whose previous run-in with the agency resulted in the company pulling its TV, web and radio ads for its $99 genetic tests.

The warning letters sent to DNA4Life, Interleukin Genetics and DNA-Cardiolock are just the most recent in a long line of FDA pushback for the industry. Pathway Genomics recently received a warning letter from the FDA for marketing their direct-to-consumer liquid biopsy DNA test, without the proper “approval, clearance or listing.”