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 […]
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 […]
The FDA is standing behind comments made by the chief of its medical device arm, Dr. Jeffrey Shuren, during testimony before a U.S. House committee last summer on direct-to-consumer genetic tests.
The remarks, made during a House Energy & Commerce Committee hearing on whether DTC genetic tests should be regulated by the Food & Drug Administration, passed un-noticed for the better part of a year until a video posted on FDAblog.org drew the attention of genetics researchers and bloggers this month.
23andMe Inc. closed its C round to raise $22 million from equity-based financing.
The Mountain View, Calif.-based genetics company said the funding came from the Johnson & Johnson Development Corp. (NYSE:JNJ), a new investor, and previous investors including New Enterprise Associates and Google Ventures (NSDQ:GOOG).