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News Worms


FDA green-lights more 23andMe genetic tests

FDA green-lights more 23andMe genetic tests

Known as the 23andMe Personal Genome Service Genetic Health Risk tests, they assess a person's inherited risk for 10 diseases and conditions.

The agency said the new tests may help people make decisions about lifestyle and help them have informed discussions with health care professionals.

Hoping to streamline approvals, the FDA plans to exempt additional 23andMe genetic health risk tests from its pre-market review.

Included in the list are Alpha-1 antitrypsin deficiency, a disorder that raises the risk of lung and liver disease, Factor XI deficiency, a blood clotting disorder, Gaucher disease type 1, an organ and tissue disorder, early-onset primary dystonia, a movement disorder, and various blood disorders. A California company will now market that genetic test.

The tests are easy to use and isolate DNA from a saliva sample, which can be sent away to be tested for more than 500,000 genetic variants thought to be related to these diseases.

After being granted FDA approval on Thursday, the company says the tests will be available to the public in April.

Genetic screening for diseases including cancer have been getting cheaper and more consumer focussed in recent years, although most - like another recent start-up, the U.S. cancer-screening company Color - have still recommended going through a doctor. The decision is expected to open the floodgates for more direct-to-consumer tests for disease risks, drawing a road map for other companies to do the same thing. "If this goes into your medical record it's not going to be very hard for people to have access to it or to be discovered", Minazad said.

But some are stillconcerned about whether the genes in question actually correspond to a higher risk of disease reliably enough to warrant direct-to-consumer marketing and testing, as opposed to genetic testing with the guidance of a professional. But, he wrote in a statement following the FDA's announcement, the foundation recommends "that people who are interested in testing first seek guidance from their doctors and from genetic counselors to understand what the process may mean for them and their families".

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