TEST:

23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

"23andMe Holding Co...today announced the Company has received a U.S. Food and Drug Administration (FDA) 510(k) clearance to expand its existing BRCA1/BRCA2 (Selected Variants) 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....In addition to the 510(k) clearance, the FDA also granted 23andMe the first-ever Predetermined Change Control Plan (PCCP), which allows the Company to add additional validated BRCA1 and BRCA2 variants and associated cancer risk information to its BRCA1/BRCA2 (Selected Variants) report without additional premarket review."

"23andMe Holding Co...today received FDA clearance for a genetic health risk report on a hereditary prostate cancer marker...This is the Company’s third cancer risk report clearance, following the FDA’s prior authorization for 23andMe’s BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report and its clearance for MUTYH-Associated Polyposis (MAP), a hereditary colorectal cancer syndrome...These two reports along with the new Hereditary Prostate Cancer (HOXB13-Related) report have been included by the FDA in a single 'Cancer Predisposition Risk Assessment System' regulation...These three 23andMe reports are the only direct-to-consumer genetic health risk reports for inherited cancers that have been authorized by the FDA for use without prescription."

"In addition, of the 343 carriers who provided both ancestry and family history information, 44% did not have a first-degree family history of a BRCA-related cancer and, in the absence of a personal history of cancer, would therefore be unlikely to qualify for clinical genetic testing. These findings may help inform the discussion around broader access to BRCA genetic testing."