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Medical Devices / Submissions and Approvals

23andMe Receives Clearance for MUTYH-Associated Polyposis Genetic Test

Jan. 24, 2019

23andMe received 510(k) clearance from the FDA for its consumer genetic test, which looks for genetic variants that can lead to increased risk of colorectal cancer.

The test reports on the two most common genetic variants that influence MUTYH-associated polyposis, a hereditary colorectal cancer syndrome.

The syndrome is caused by genetic mutations and is characterized by a significantly heightened risk of colorectal cancer in a patient’s lifetime.

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