FDA Allows Direct-To-Consumer Genetic Tests

One year after a very public squabble with genetic-testing company 23andMe, the Food and Drug Administration has decided not only to allow 23andMe to directly market its genetic test to consumer as a diagnostic device, but to free other genetic-testing companies from pre-market review or prescription status:

“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. 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,” said 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. “These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children.”

This is a very big deal. Genetic-testing companies will be able to innovate and launch new tests with little fear of being held up at the FDA. And consumers will be able to order genetic tests without bureaucratic interference. I anticipate that many will pay cash to do so (as they have already been doing).

The FDA has shown admirable self-control by withholding regulation of mobile health apps and devices for health and wellness. The latest decision on genetic tests confirms a welcome trend in regulatory restraint.

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