23andMe has received clearance from the Food and Drug Administration (FDA) to market a direct-to-consumer genetic health risk report on a hereditary colorectal cancer syndrome.
While more than 100 variants in the MUTYH gene have been linked with MUTYH-associated polyposis, the MUTYH-Associated Polyposis Genetic Health Risk report identifies the 2 most common genetic variants in people of Northern European ancestry. Carrying both of these variants or having 2 copies of 1 of these variants may increase an individual’s risk of developing colorectal cancer. The report, however, does not account for variants associated with Lynch syndrome, the most common type of inherited colorectal cancer.
Clearance through the 510(k) submission pathway makes this the second 23andMe direct-to-consumer genetic risk report for an inherited cancer to be authorized by the FDA without the need for a prescription; the BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report was cleared last March.
While not yet available, the MUTYH-Associated Polyposis Genetic Health Risk report will be offered to both new and existing Health + Ancestry Service customers; customers must choose whether or not they want to receive the information and for those who do, an education module will be included to help them interpret the results.
For more information visit 23andme.com.