FDA Relaxes Stance On Personal Genetics Testing, Clears 23andMe To Resume Sales

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In November 2013, the FDA sent a letter to a personal genetic testing startup called 23andMe explaining that the company’s direct-to-consumer genetic test needed to be pulled from the shelves because it had not secured the necessary FDA clearance, and because it had not proven that the test results being presented to consumers were “accurate, reliable, and clinically meaningful.” The letter was a major news event in health IT because it led to the eventual shuttering of 23andMe’s flagship product a genetic test that identifies which diseases a person is at a higher risk of contracting, based on their inherited genes.

Now, nearly two years later, the FDA has granted 23andMe clearance to bring its direct-to-consumer genetic tests back to the market. The hard-won clearance does not let 23andMe return all components of its genetic test to market, but it does authorize the company to resume sales of “carrier screening tests,” which are tests that determine whether a healthy person is a carrier of genetic mutations that could be unknowingly passed on to their offspring in the form of dangerous inherited diseases. Today, parents don’t usually find out that they are carriers of a high-risk genetic mutation until their child is diagnosed with a disease. While couples with a family history that includes dangerous inherited conditions are encouraged to have genetic tests performed before having children, the general public is, for the most part, unaware of their own carrier status.

The FDA is hoping to change this by reclassifying all “carrier screening tests” as class II medical devices and granting them exemption from premarket review. “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,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics. “These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children.”

While this new, relaxed approach to regulating direct-to-consumer genetic tests is good news for the industry, 23andMe will only see a limited upside. The only screening from its original personal genetic test that will now be authorized for resale is a screening test for Bloom syndrome, a very rare disorder found primarily within Ashkenazi Jewish families. Bloom syndrome causes facial and stature deformities, and a predisposition toward developing cancer. Now, with a clear pathway to market defined by the FDA, 23andMe and its competitors can start rolling out new carrier tests to help couples understand the genetic risks their offspring will inherit.


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