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23andme

FDA clears 23andMe for pharmacogenetics testing

November 1, 2018 By Danielle Kirsh

The FDA recently cleared a pharmacogenetic DNA test from 23andMe that is designed to determine how users will react to certain pharmaceutical drugs. The FDA cleared the new 23andMe test to give information on 33 genetic variants that determine how patients will respond to more than 50 different prescribed and over-the-counter medications. The test, which […]

Filed Under: Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance Tagged With: 23andme

23andMe is back: FDA allows marketing of genetic health risk tests

April 21, 2017 By Chris Newmarker

23andMe

FDA this month allowed genetic testing company 23andMe to market genetic health risk tests for 10 diseases and conditions including Parkinson’s disease and late-onset Alzheimer’s disease. The de novo premarket review authorization, announced April 6, also included celiac disease, which results in the inability to digest gluten; alpha-1 antitrypsin deficiency, which raises the risk of […]

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: 23andme, FDA, medtech

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