Unapproved At-Home Genetic Tests Might Run Afoul of the FCA and the FDCA

Recently, the Food and Drug Administration ordered genetic-testing company 23andMe Inc. to stop marketing its mail-order genetic testing kit, citing the risk that false results could cause consumers to undergo unnecessary medical procedures, or forego recommended medical procedures.

In 2010, the FDA expressed concerns about the emerging field of direct-to-consumer genetic tests, which the agency considered to be fraught with “high risks.” At that time, the FDA told 23andMe and other similar companies that it considered their at-home genetic tests to be medical devices requiring FDA approval.

A FDA spokeswoman told the Wall Street Journal that the FDA “needs to review genetic tests sold directly to consumers to make sure they are safe and do what they claim to do.” She said the agency issued its warning letter to 23andMe “after the company repeatedly failed to address specific concerns outlined by the agency since 2009.”

According to the FDA warning letter, because 23andMe’s genetic tests lacked requisite FDA approval or clearance, the tests were considered adulterated and misbranded under the Federal Food, Drug, and Cosmetics Act (FD&CA).

If they yield unreliable, inaccurate or false test results, these and other medical devices run afoul of the federal False Claims Act.