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FDA OKs Marketing of Direct-to-Consumer Genetic Risk Tests

FRIDAY, April 7, 2017 -- The U.S. Food and Drug Administration has approved the first home genetic tests for 10 diseases or conditions, including Parkinson's disease and late-onset Alzheimer's.

The approval -- granted to the California-based company 23andMe Inc. -- could help test users make lifestyle choices or spark important discussions with health care providers, the FDA said. The newly approved tests work by isolating DNA from a saliva sample. The DNA is then tested for more than 500,000 genetic variants. The presence or absence of these variants is linked with higher risk for any one of 10 diseases and conditions.

Besides Parkinson's or late-onset Alzheimer's disease, they include: celiac disease; alpha-1 antitrypsin deficiency; early onset primary dystonia; factor XI deficiency (hemophilia C); and Gaucher disease type 1. The other three are glucose-6-phosphate dehydrogenase deficiency; hereditary hemochromatosis; and hereditary thrombophilia.

Hoping to streamline approvals, the FDA plans to exempt additional 23andMe genetic health risk tests from its pre-market review. It said it may also exempt such tests from other companies that meet preliminary expectations. By establishing special controls and a pre-market review exemption, "the FDA can provide a streamlined, flexible approach for tests using similar technologies to enter the market while the agency continues to help ensure that they provide accurate and reproducible results," Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said Thursday in an agency news release.

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Posted: April 2017

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