FDA Approves 23andMe Genetic Testing for Direct Consumer Purchase

The United States Food and Drug Administration has just announced the first approved home genetic test for 10 health risks. The test can determine risk for various genetic conditions including Parkinson’s Disease and late-onset Alzheimer’s Disease.

Basically, the FDA has granted this approval for the California-based company 23andMe Inc; a company named, of course, after the 23 sets of chromosomes that contains all of the genetic coding within the human body.
Dr. Jeffrey Shuren—the director of the FDA Center for Device and Radiological Health—comments, “Consumers can now have direct access to certain genetic risk information,” in a news release, Thursday.
Along with this release, the announcement notes that diagnostic genetic testing materials continue to be “excluded from today’s marketing authorization and any future, related exemption.”
Some of examples of such diagnostic testing materials include the relatively new test to determine if a woman has the BRCA genetic mutation that makes them more vulnerable to breast cancer; a test which helps to assess the benefit of undergoing preventive mastectomies or other related surgeries that could reduce risk for cancer.
Scott Gottlieb, MD, has previously argued against the FDA’s prior policy on the 23andMe genetic tests. Now, it looks like he is focused on leading the agency in this movement. In a recent note, Gottlieb wrote, “The agency is trying to regulate mental responses to the data supplied by the tests – how others interpret or decide to act on accurate science.”

He continues, “Dodging the First Amendment requires more than loose speculation about the possibility that the molecular scripts of life are too subtle and important to be read with impunity by the masses.”

But just this week, 23andMe has managed to reinforce the idea that consumers deserve to have access to their own genetic information in order to help them make more-informed decisions about the direction of their healthcare. As such, they applaud the FDA’s decision to allow the sale of these genetic tests directly to consumers.

23andMe co-founder and chief executive officer, Anne Wojcicki comments, “This is an important moment for people who want to know their genetic health risks and be more proactive about their health. The FDA has embraced innovation and has empowered individuals by authorizing direct access to this information. It is a significant step forward for 23andMe and for the adoption of personal genetics. But, it is important that people understand that genetic risk is just one piece of the bigger puzzle. It does not mean they will or won’t ultimately develop a disease.”

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