DNA Company 23andMe Gets FDA Approval for Consumer Cancer Test
DNA testing company 23andMe has gotten approval from the FDA for a consumer test detecting hereditary colorectal cancer syndrome by determining whether customers have two genetic variants that influence MUTYH-associated polyposis, a rare condition associated with an increased risk of colorectal cancer. It is 23andMe’s second test for cancer risk cleared by the FDA.
The company’s BRCA tests, developed to determine breast cancer risk, were released last year amidst some controversy. Though there are more than 1,000 known BRCA gene mutations, the 23andMe test focused on three variants most common in people of Ashkenazi Jewish descent. This is not to mention a general concern about such tests being sold directly to consumers, without the insight of a doctor or genetic counselor.