MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

23andMe Keeps Snagging FDA Nods for Cancer Marker Tests

michelmond / Alamy Stock Photo IMG_2022-1-11-125620.jpg
The Sunnyvale, CA-based company said it has won FDA clearance for a genetic health risk report on a hereditary prostate cancer marker.

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

 

 

Hide comments
account-default-image

Comments

  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Publish