Jan 11, 2022

23andMe Gets FDA Clearance for Prostate Cancer Risk Test

Genetics testing company 23andMe received Food and Drug Administration clearance for its prostate cancer risk test. It’s 23andMe’s third clearance for a cancer risk report — the company also has tests for genes that predict breast and colorectal cancer risk.

The test screens for a specific mutation on the HOXB13 gene linked with an increased risk of developing prostate cancer. Men with the mutation, the G84E variant, have around a three-fold higher chance of developing prostate cancer than men without, one study found. Around one in 70 people of European descent have the variant, according to a statement from 23andMe.

The prostate cancer risk report is not yet available to 23andMe customers, the company said. Customers will be able to choose whether or not they want to see their results. Those that choose to see it will also get access to an “educational module” to give them information about how to interpret the results.

Details may be found in an article by Nicole Wetsman in The Verge web site at: