Consumer-driven precision medicine gets boost from FDA

President Barack Obama's Precision Medicine Initiative promises a "new era of medicine--one that delivers the right treatment at the right time," and seeks $215 million to expand access to genetic data in order to better target disease treatments.

But while much focus has been on the implications of the initiatives for healthcare providers, the Food and Drug Administration (FDA) announced Friday that for the first time, it will allow a company to market a genetic test directly to consumers.

The company is called 23andMe, and the FDA's authorization affects a test that can determine whether healthy people have a gene variant that can lead their offspring to inherit Bloom Syndrome, a rare disorder characterized by short stature, sun-sensitive skin changes, an increased risk of cancer and other health problems, according to Genetics Home Reference.

Perhaps even more significant than the 23andMe test authorization, however, is the FDA's simultaneous announcement that it will exempt other direct-to-consumer genetic tests from the agency's premarket review--a move that Forbes called a "big win" for consumer access to low-cost genetic tests.

"The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in the announcement. "Today's authorization and accompanying classification, along with FDA's intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers."

Insurers also seem to be jumping on board, as Priority Health announced this week that it will cover comprehensive genetic testing for patients diagnosed with aggressive forms of cancer, FierceHealthPayer reported.

And last week, the National Institutes of Health (NIH)--which is set to receive $130 million to pursue the Precision Medicine Initiative--convened working groups of epidemiology, genomics, privacy, health information and mobile technology experts to produce a serious of whitepapers related to the initiative. The four reports "identify challenges and opportunities" related to building a large research cohort of genetic data as well as outline concrete steps to meet these challenges, according to the NIH.

One of the most pressing challenges the initiative faces is the privacy concern associated with such a large-scale collection of private health data, FierceHealthIT reported. But Jo Handelsman, associate director for science at the White House Office of Science and Technology Policy, told reporters in a Jan. 29 conference call that patients' privacy will be "rigorously protected," noting that her office has already begun to assemble working groups to offer guidance on the subject, according to FierceHealthcare.

To learn more:
- check out the FDA announcement
- read the Forbes article
- access the NIH whitepapers

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