Silicon Valley consumer genetics testing company 23andMe said it has received regulatory clearance from the FDA for a new diagnostic to asses the risk for a type of hereditary colorectal cancer.
The company, which has previously received FDA authorization to test for selected variants of the BRCA mutation for potential breast cancer risk, used the 510(k) submission pathway for its new screening with its previous clearance acting as a predicate.
The MUTYH-Associated Polyposis screening looks at two genetic variants that can increase the odds of developing colorectal cancer by up to 100 percent, according to 23andMe.
It is important to note the test does not examine variants associated with Lynch Syndrome, the most common form of hereditary colorectal cancer.
While not currently available to the public, the report will eventually be offered as part of the company’s Health + Ancestry Service, which helps consumers understand their genealogical history along with potential genetic health risks.
“We are committed to giving people affordable and direct access to important health information that can impact their lives,” 23andMe CEO Anne Wojcicki said in a statement.
“We believe improved access to genetic testing and health information will help people engage in their own health.”
After the FDA cracked down on 23andMe’s claims that it could screen for dozens of potential genetic conditions, the company has played nice with regulators in order to bring their health-oriented products to market.
In addition to its cancer screenings, the company also worked with the FDA to get its Personal Genome Service Pharmacogenetic Report approved last year which is designed to provide more information about patients’ ability to metabolize drugs.
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