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23andMe Gains FDA Clearance for Direct-to-Consumer Prostate Cancer Genetic Risk Test

NEW YORK – 23andMe said Monday that it has received 510(k) clearance from the US Food and Drug Administration for a direct-to-consumer genetic risk report for hereditary prostate cancer that is based on the HOXB13 marker.

The test looks for the G84E variant, which is most prevalent in individuals of Northern European ancestry. Between 33 percent and 53 percent of men who carry the variant develop prostate cancer during their lifetime, compared to 12 percent of men in the general population.

This is 23andMe's third FDA clearance for a cancer risk report. The genetic testing firm previously passed 510(k) reviews for its MUTYH-associated polyposis report for hereditary colorectal cancer and another for three BRCA1/BRCA2 mutations, and said that it is the only company with multiple FDA clearances for DTC genetic health reports.

The Sunnyvale, California-based company has not yet released the HOXB13 test to market but said that it will be offered as an add-on to customers of its Health + Ancestry Service who have been genotyped on the firm's most recent platform.

"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," cofounder and CEO Anne Wojcicki said in a statement.

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