COMPANY:

23andMe

"23andMe Holding Co...released three new genetic reports for 23andMe+ members on breast, colorectal and prostate cancer. The reports are based on statistical models known as polygenic risk scores (PRS), developed by 23andMe through its proprietary research database. These PRS reports calculate the likelihood of an individual developing one of these cancers, based on thousands of genetic variants associated with the disease."

"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."