BioCentury
ARTICLE | Clinical News

Personal Genome Service Genetic Health Risk (GHR) test regulatory update

April 14, 2017 7:40 PM UTC

FDA approved 23andMe's PGS Genetic Health Risk (GHR) test to assess genetic risk for 10 diseases and conditions. The approved indications are Parkinson’s disease (PD), late-onset Alzheimer’s disease (AD), celiac disease, alpha-1 antitrypsin (AAT; A1AT; SERPINA1) deficiency, early-onset primary dystonia, Factor XI deficiency, Gaucher's disease Type I, glucose-6 phosphate dehydrogenase (G6PD) deficiency, hereditary hemochromatosis and hereditary thrombophilia. 23andMe said the personal genetic test, which FDA approved through the de novo premarket review pathway, is the first direct-to-consumer test for genetic predisposition approved by FDA.

FDA said the approval excludes the use of GHR tests as diagnostic tests, which are “often used as the sole basis for major treatment decisions” such as preventive surgery. The agency said it intends to exempt from premarket review any future GHR tests from 23andMe. The exemption on future tests for genetic health risk would also apply to other companies once those companies have submitted the premarket notification for their first test...

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