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On February 19, the US Food and Drug Administration (FDA) authorized 23andMe to market a direct-to-consumer (DTC) carrier test for Bloom syndrome. The agency's decision to classify such carrier screening tests as class II medical devices, and exempting them from premarket review, may pave the way for a return of DTC genetic testing. The decision and the open door, however, have garnered mixed reviews from genetic counsellors and clinicians.

"This is the first step in our commitment to returning health information to our customers. Because this process was successful, we may be able to submit some future submissions through the standard 510(k) pathway," a spokesperson for 23andMe, based in Mountain View, California, told Medscape Medical News

FDA had banned the company from DTC marketing of genetic tests with a warning letter sent November 22, 2013, claiming that their "Personal Genome Service," termed "information," violated the Federal Food, Drug and Cosmetic Act. The company was selling the service without submitting evidence of accuracy, reliability, and clinical meaning.

Pros and Cons of DTC Genetic Testing

Genetics professionals had mixed reactions...