FDA cracks down on genetic test makers for direct-to-consumer marketing

Regulators sent a warning letter to Fairhope, AL-based DNA4Life for selling its Pharmacogenetic Report without clearance even though the tool qualifies as a medical device.  The report, which runs at $249, predicts how patients will respond to more than 120 of the most commonly prescribed meds.  The FDA said in its letter that it has “been unable to identify any FDA clearance number” for the product. DNA4Life is staying quiet on the letter, but said in an earlier interview that it did not believe that it needed FDA approval to sell its test, Reuters reports.

Regulators also came down on Interleukin and DNA-Cardiocheck for similar offenses. Waltham, MA-based Interleukin sells tests to identify people who have a genetic predisposition for increased risk of heart attack, diabetes, obesity or weight problems.  The Agency said it could not find clearance numbers for the tests and also pointed to an earlier letter from the company, which claimed that its products were “laboratory developed tests.”  However, contrary to this claim, “it appears that at the present time, your firm is offering these tests under a direct-to-consumer model,” the FDA said in its recent letter to the company.

DNA-Cardiocheck is facing the agency’s ire over its DNA-CardioCheck DTC test, which screens for DNA genetic markers associated with heart disease and stroke.  The Agency is asking the Lisle, IL-based company to provide the FDA clearance number for the device, or evidence proving why the product doesn’t need approval.  

The letters come amid a flurry of DTC genetic testing, as more companies look to hop on the bandwagon after 23andMe scored an FDA blessing earlier this year for its DTC product.  In February 2015, the Mountain View, CA-based company got an OK for its genetic carrier test for Bloom syndrome, opening the door for similar devices to enter the market. 23andMe recently notched FDA approval to roll out its $199 service with more than 60 health, ancestry, wellness and personal genetic trait reports, including one that provides information about whether people have genetic mutations that could lead to a disease in their children.

However, the company traveled a long road to achieve those milestones after falling out of the FDA’s good graces a couple of years ago.  In December 2013, the FDA slapped 23andMe with a scathing warning letter for its $99 genetic tests, accusing the company of selling the product without proper approval or required data and prompting 23andMe to pull it’s TV, web and radio ads for the test.

DNA4Life, Interleukin and DNA-Cardiocheck aren’t the only testing companies facing regulatory pushback.  In September 2015, the FDA sent San Diego-based Pathway Genomics a warning letter for marketing its liquid biopsy DNA test directly to consumers without proper “approval, clearance or listing,” the agency said at the time.

REFERENCE:  Fierce Medical Devices; 10 NOV 2015; Emily Wasserman

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