STAT – Federal regulators approved the first direct-to-consumer test for the BRCA genes, which increase the risk of breast and ovarian cancer, the agency announced on Tuesday.
The test for the BRCA1 and BRCA2 genes, from 23andMe, uses a saliva sample. But it assesses only three of the more than 1,000 known BRCA1/2 mutations, raising concerns that women who are told they do not have any of those variants will be lulled into believing that, as a result, they do not have an elevated risk for breast and ovarian cancer.
The three specific BRCA1/BRCA2 breast cancer gene mutations are most common in people with Ashkenazi (Eastern European) Jewish ancestry, but even in this population only 2 percent of women carry any of the mutations, the FDA said. Women with one of the mutations have a 45 percent to 85 percent chance of developing breast cancer by age 70, 23andMe said.
Read more at STAT.