The possibility of strict regulation of direct-to-consumer (DTC) genetic tests in the US continues with further warnings from the Food and Drug Administration (FDA) issued to companies.
The FDA began sending warning letters that commercial tests or services might require regulatory approval as medical devices last year (see previous news). Earlier this month a fresh batch of letters went out; Lumigenix offers genetic predisposition testing similar to that of other DTC companies, whereas PQDNA is more unusual in offering solely a service to help consumers understand genetic data and identify information relative to health. Their CEO Andre Gous has said that the FDA could "regulate the industry into de facto oblivion” and that they risk overextending their regulatory reach, adding that it is nonsensical "to consider DNA 'spit tubes' as 'medical devices’".
The third company invited asked by the FDA to make a case for why their products should not be subject to medical device regulation is AIBiotech, which sells the controversial new Sports X Factor Test Kit, which claims to enhance athletic performance in young people by using genetic information to determine how to tailor training, determine how much rest is needed following head injuries, and assess the risk of inherited cardiac conditions. Experts are concerned about the veracity of the medical claims for this test, and potential dangers to children whose parents opt to have them tested.
Comment: This is a difficult situation; whilst the FDA has a clear legal requirement to regulate medical devices to protect consumers from harm including inaccurate test results or clinical interpretations, attempting to define any type of genetic testing and even interpretation services as medical devices is a stretch. Clearly, some sort of regulatory oversight for medical claims is needed, but so is a common-sense approach.