23andMe Receives FDA Clearance for Direct-to-Consumer Genetic Test in Colorectal Cancer

23andMe received Food and Drug Administration (FDA) clearance for a genetic health risk report on a hereditary colorectal cancer syndrome, according to the genetics company.
BY Kristie L. Kahl
PUBLISHED January 22, 2019
23andMe received Food and Drug Administration (FDA) clearance for a genetic health risk report on a hereditary colorectal cancer syndrome, according to the genetics company.

"We are committed to giving people affordable and direct access to important health information that can impact their lives," Anne Wojcicki, 23andMe CEO and co-founder, said in a press release. "We believe improved access to genetic testing and health information will help people engage in their own health."

The clearance followed 23andMe's BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report – titled the MUTYH-Associated Polyposis report – published in March 2018. The report, which was submitted to the FDA using the 510(k) submission pathway, is what enabled the agency’s clearance of the genetic test for the BRCA mutation.

Not yet available, the report will be offered to new Health + Ancestry Service customers as well as existing 23andMe Health + Ancestry Service customers who have been genotyped on the company's most recent platforms, where customers must choose whether or not they want to receive this information.

The test will also include an education module to inform customers on what they can learn from this report, how to interpret the results, and the test’s limitations.

 
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