In 2015, the FDA authorized the marketing of the first DTC genetic health-related test for Bloom syndrome. Since then 23andMe has received FDA authorization in all four categories of DTC genetic tests felt to have an impact on medical care.
These categories include genetic health risk, carrier screening, pharmacogenetics and cancer predisposition. Evaluation and regulation of DTC genetic tests by the FDA are based on analytic validity, clinical validity and how well a consumer understands the descriptive information about the test and its results without the participation of a healthcare provider.
23andMe is the only DTC genetic testing company to receive marketing authorization by the FDA in all four health categories. We currently provide over 60 Genetic Health Risk, Cancer Predispositions, Pharmacogenetics, and Carrier Status reports* to our customers. We believe genetics can be an integral part of healthcare and will continue to work with the FDA to release additional reports.