23andMe Genetic Test for Prostate Cancer Risk Cleared

January 13, 2022

Sunnyvale, Calif.-based consumer genetics and research company 23andMe has received the FDA’s 510(k) clearance for a genetic health risk report on a hereditary prostate cancer marker — the HOXB13 G84E gene mutation.

The gene mutation, which is found in about one in 70 people with Northern European ancestry, has been shown to be associated with the risk of prostate cancer.

This is the company’s third clearance from the FDA for a cancer risk report. It previously received clearances for its BRCA1/BRCA2 genetic health risk report and a report on the risk of the hereditary colorectal cancer syndrome, MUTYH polyposis.

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