FDA News

23andMe receives FDA clearance for hereditary colorectal cancer syndrome genetic test

FDA granted clearance to 23andMe’s genetic health risk report for MUTYH-associated polyposis, a hereditary colorectal cancer syndrome.

The MUTYH-Associated Polyposis report — although not yet available — is a direct-to-consumer genetic test that is cleared by the FDA for use without prescription. This clearance followed the FDA’s authorization for 23andMe’s BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report last March.

“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 two variants included in the MUTYH-Associated Polyposis report account for 80% to 90% of MUTYH variants in people of Northern European descent, although they also have been found in people of other ethnicities.

Between 1% and 2% of people of Northern European ancestry harbor one of these two variants. Harboring both of these variants or two copies of one variant increases colorectal cancer risk by 43% to 100%; however, the risk associated with just one variant is unclear.

23andMe noted several limitations of the report, including that hereditary colorectal cancers account for only about 5% of all cases. Further, the report does not assess variants associated with Lynch syndrome, the most common form of inherited colorectal cancer.

Also, although this report looks at just two variants, there are more than 100 variants in the MUTYH gene that are linked to MUTYH-associated polyposis.

The FDA included both the MUTYH-Associated Polyposis report and the BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report in one “Cancer Predisposition Risk Assessment System” regulation. 23andMe submitted both reports to the FDA using the 510(k) submission pathway.

FDA granted clearance to 23andMe’s genetic health risk report for MUTYH-associated polyposis, a hereditary colorectal cancer syndrome.

The MUTYH-Associated Polyposis report — although not yet available — is a direct-to-consumer genetic test that is cleared by the FDA for use without prescription. This clearance followed the FDA’s authorization for 23andMe’s BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report last March.

“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 two variants included in the MUTYH-Associated Polyposis report account for 80% to 90% of MUTYH variants in people of Northern European descent, although they also have been found in people of other ethnicities.

Between 1% and 2% of people of Northern European ancestry harbor one of these two variants. Harboring both of these variants or two copies of one variant increases colorectal cancer risk by 43% to 100%; however, the risk associated with just one variant is unclear.

23andMe noted several limitations of the report, including that hereditary colorectal cancers account for only about 5% of all cases. Further, the report does not assess variants associated with Lynch syndrome, the most common form of inherited colorectal cancer.

Also, although this report looks at just two variants, there are more than 100 variants in the MUTYH gene that are linked to MUTYH-associated polyposis.

The FDA included both the MUTYH-Associated Polyposis report and the BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report in one “Cancer Predisposition Risk Assessment System” regulation. 23andMe submitted both reports to the FDA using the 510(k) submission pathway.