The FDA has granted 510K clearance to 23andMe’s direct-to-consumer (DTC) genetic health risk report on a hereditary marker for prostate cancer.1
The clearance is specifically for reporting on the G84E mutation in the HOXB13 gene. Research has shown that harboring this mutation significantly increases a man’s prostate cancer risk.
The FDA’s 510(k) clearance designation allows a company to market a medical device in the United States if the company can prove that its device is “substantially equivalent” to a device already being legally marketed
“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,” Anne Wojcicki, CEO and Co-Founder of 23andMe, stated in a press release. “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.”
According to 23andMe, clinical research has shown that up to half (33%-53%) of men harboring the G84E variant will develop prostate cancer, and these men also tend to develop the disease at an earlier age. Also of note, the prevalence of G84E mutations is highest among men with Northern European ancestry.
The company emphasized in the news release that their test does not assess for all genetic markers of enhanced prostate cancer, and that the report is not a substitute for recommended cancer screenings.
1. 23andMe Receives FDA Clearance for Direct-to-Consumer Genetic Test on a Hereditary Prostate Cancer Marker Published online January 10, 2021. Accessed January 10, 2021. https://bit.ly/3zHqltf.