Personal genetics specialist, 23andMe received a nod from FDA for a genetic health risk report on a hereditary colorectal cancer syndrome.
FDA’s nod for the Mountain View, CA-based company’s MUTYH-Associated Polyposis Genetic Health Risk report follows a previous authorization for the BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report in March 2018.
The MUTYH-Associated Polyposis report was submitted to the FDA using the 510(k) submission pathway, enabled by the BRCA decision in March 2018.
"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 release. "We believe improved access to genetic testing and health information will help people engage in their own health."
Like with other 23andMe Genetic Health Risk reports, the company said this one will also include an education module to ensure customers are informed on what they can learn from this report and how to interpret the results, as well as its limitations.
This clearance follows several years of work by the company that has led to four separate FDA de novo authorizations for direct-to-consumer genetic tests for carrier status, genetic health risk reports, select BRCA1 and BRCA2 variants and pharmacogenetic reports.