23andMe has won FDA clearance for a direct-to-consumer genetic test on a hereditary prostate cancer marker. The nod comes from nearly a year after the Sunnyvale, CA-based company announced it was going public through a special purpose acquisition corporation (SPAC) merger with VG Acquisition.
The clearance is specifically for the Hereditary Prostate Cancer (HOXB13-Related) report.
This marks the third FDA clearance 23andMe has obtained for a cancer risk report clearance. Prior to the most recent clearance, the company has nods for the BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report and the MUTYH-Associated Polyposis (MAP), a hereditary colorectal cancer syndrome.
“We continue to work closely with 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.”
23andMe has garnered much acclaim in the medtech and diagnostics industry. The firm was one of MDDI’s 2016 Medtech Company of the Year Finalists.