23andMe Gets FDA OK on Direct-to-Consumer Genetic Test on Hereditary Prostate Cancer Marker

 

The clearance allows 23andMe to report on the G84E mutation in the HOXB13 gene, clinically shown to significantly increase the risk of developing prostate cancer in men with the mutation

 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading consumer genetics and research company, 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.

“We continue to work closely with the FDA in order to provide individuals with direct access to impactful health information that can help them make important life decisions,” said Anne Wojcicki, CEO and Co-Founder of 23andMe. “23andMe remains the only company with multiple FDA authorizations for direct-to-consumer genetic health reports. These reports provide our customers with the knowledge that they might be at risk for certain diseases, including hereditary cancers, empowering them to take appropriate preventative action with their healthcare provider.”

https://mediacenter.23andme.com/press-release/23andme-receives-fda-clearance-for-direct-to-consumer-genetic-test-on-a-hereditary-prostate-cancer-marker