Genetic genealogy and health testing company 23andMe announced that the FDA has authorized the company to issue 10 new genetic health risk reports to customers. Those include Late-Onset Alzheimer’s Disease, Parkinson’s Disease, Hereditary Thrombophilia, Celiac Disease and others (see the rest of the authorized report and a description of each condition in this 23andMe blog post).
The FDA in 2013 ordered 23andMe to stop offering its health analysis, which informed test-takers about their risks for 254 diseases and conditions, because the company hadn’t proven its tests were “analytically or clinically validated.” After negotiations with the FDA, 23andMe began offering more-limited health-related reports in 2015.
To obtain the FDA’s authorization for the new reports, 23andMe “conducted extensive validation studies for accuracy and user comprehension that met FDA standards,” according to its blog. The FDA also established a new authorization pathway for future 23andMe reports that are “substantially equivalent” to those already approved, which should facilitate reports on additional conditions.
The company will release the new set of genetic health risk reports in April. New customers will receive the reports when they’re available. Customers who’ve already tested should look for an email from 23andMe about their eligibility to receive the new reports (this has to do with your geographic location and the genotyping “chip” used for your original test). See more details on the 23andMe blog.
Learn how to use DNA testing in your genealogy research from our guidebook, The Family Tree Guide to DNA Testing and Genetic Genealogy.