Genetic Tests Count as Devices, says FDAGenetic Tests Count as Devices, says FDA

Director of the Office of In Vitro Diagnostic Device Evaluation, CDRH, Alberto Gutierrez said the tests constitute medical devices because they are "intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease" or are "intended to affect the structure or function of the body."

In a statement, 23andMe said, "We disagree with the FDA's conclusion. ... We carefully explain to our customers that the data we provide is informational and educational." If customers want to use the information for medical decision-making, the statement says, 23andMe cautions that they consult with a doctor.

Navigenics took a similar stance, saying, "We believe our services comply with all existing federal and state regulations, and look forward to continuing our dialogue with the FDA to ensure transparency and the optimal use of genetic information as it applies to personalized medicine.

Some of the tests cited by the FDA have been sold for more than two years, and Gutierrez's letters say agency officials met with company representatives last summer. When asked why the FDA only now sent the letters, Gutierrez told the press, "If you look at the claims, they have continued to change." Although they might have started out offering tests to determine paternity or ancestry, "they began slowly making claims that we would consider high-risk, more medical-device-type claims."

According to Caroline Wright, head of science at the PHG Foundation, classifying these kits as devices may not be enough. "One of the biggest issues is that, while classifying DTC genetics tests as devices is certainly appropriate for assessing their analytical validity and direct safety, it does not and cannot provide an assessment of the service. Unlike testing kits, for which the devices legislation is designed, genome scans include an additional element of interpretation provided by the companies. This aspect of the testing service is extremely difficult to regulate, not least because the interpretation and performance of the test vary substantially between different contexts. Hence standard medical testing has traditionally been overseen by professional medical bodies. Simply trying to classify the complete genomic testing service as “a device” is entirely inadequate and will not address the difficult issues at hand."

However, she notes that the technology is not yet accurate enough to be used as a medical tool, and therefore suggests that "the best way to deal with this issue may be to ensure transparency and the provision of accurate information to consumers, to allow them to make informed decisions and to minimize the opportunities for harm."