23andMe just won the first FDA approval to market genetic tests for estimating personal risk of having diseases such as late-onset Alzheimer’s, Parkinson’s, celiac, and hereditary thrombophilia. The company was already doing this years ago, but in 2013 the FDA ordered 23andMe to cease the practice of providing any commentary on customers’ potential for developing any diseases.
The company will be making personalized health reports available later this month, but those who wish to take advantage of the service immediately can order the kits and the results will have the new reports included.
Here’s some details about the approval according to 23andMe:
23andMe Personal Genome Service® submissions for genetic health risk reports were evaluated through the de novo classification pathway, a regulatory process for low- to-moderate-risk medical devices that are first-of-a-kind, for which special controls can be developed. In addition to general controls the process provides a reasonable assurance of safety and effectiveness of the devices (full list of authorized reports below). Further, the FDA indicated it will create a class II exemption for 23andMe’s substantially equivalent reports, opening a pathway for the company to release additional genetic health risk reports.
The company will release its first set of new genetic health risk reports including Late-Onset Alzheimer’s Disease, Parkinson’s Disease, Hereditary Thrombophilia, Alpha-1 Antitrypsin Deficiency, and a new carrier status report for Gaucher’s Disease in April, with additional reports to follow.
Link: 23andMe homepage…