23andMe cleared by FDA to report additional BRCA variants

23andMe has received an FDA 510(k) clearance to expand its existing BRCA1/BRCA2 Genetic Health Risk Report. The clearance allows 23andMe to report an additional 41 variants in the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian, prostate and pancreatic cancer. Many of the 41 BRCA variants added through this clearance are known to have a higher rate of occurrence in populations traditionally underserved by genetic testing, including the African American and Hispanic/Latino communities. This marks the company’s fourth FDA clearance for genetic cancer risk. 23andMe will now report on 44 variants in the BRCA1 and BRCA2 genes associated with a significantly higher risk of breast and ovarian cancer in females, and breast cancer in males. The variants may also be associated with an increased risk for prostate cancer, pancreatic cancer, and potentially other cancers.