23andMe gets FDA approval for consumer cancer test
Kristen V. Brown
DNA testing company 23andMe Inc. said it has gotten the green light from the U.S. Food and Drug Administration to offer consumers a test for a hereditary colorectal cancer syndrome.
- 23andMe said it will now be able to tell customers whether they have two genetic variants that influence MUTYH-associated polyposis, a rare condition associated with an increased risk of colorectal cancer. The FDA didn’t immediately respond to a request for comment.
- It’s the second test associated with cancer risk for which 23andMe has received FDA clearance. Last March, the Mountain View, California-based firm began offering a report on three genetic variants associated with increased risk of breast cancer in the BRCA1 and BRCA2 genes.
- The BRCA tests were controversial. Though there are more than 1,000 known BRCA mutations, the 23andMe test focused on three variants most common in people of Ashkenazi Jewish descent. The concern was that people not likely at risk for those variants — those not of Ashkenazi descent, for example — would mistake not having the mutations as not having any risk of breast cancer.
- There is also broad concern about such tests being offered to consumers directly, without the insight of a doctor or genetic counselor to help interpret results and plan any medical care accordingly.
- Hereditary colorectal cancers account for a minority of colorectal cancer cases, only about 5 percent, according to 23andMe.
- The new tests don’t look at variants associated with Lynch syndrome, the most common form of inherited colorectal cancer.
- Originally, 23andMe offered assessments for more than 250 diseases and conditions, but in 2013 the FDA cracked down and ordered the company to cease providing analyses of people’s risk factors until the tests’ accuracy could be validated.