23andMe Receives FDA Clearance for Genetic Health Risk Report That Looks at a Hereditary Colorectal Cancer Syndrome

23andMe received FDA clearance to report on the two most common genetic variants influencing what is called MUTYH-associated polyposis (MAP), a hereditary colorectal cancer syndrome.

This new clearance is part of 23andMe’s ongoing efforts to work with the FDA to offer additional Genetic Health Risk reports as part of its Health + Ancestry Service.

“We are committed to giving people affordable and direct access to important health information that can impact their lives,” said Anne Wojcicki, 23andMe CEO and co-founder.

The MAP report is not yet available, but as soon as it is ready for release, it will be offered to new Health + Ancestry Service customers as well as existing 23andMe Health + Ancestry Service customers genotyped on the company’s most recent platforms. Like the 23andMe BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report, customers first must choose whether or not they want to receive this information.

If a customer chooses to view their report, they’ll go through an educational module to ensure customers are informed about what they can learn from their report, and how to interpret the results. Customers also learn about the limitations of the report. This is a similar step customers take to access other 23andMe Genetic Health Risk reports.

For example, information associated with the MAP report will clearly state that hereditary colorectal cancers only account for about 5 percent of all colorectal cancer cases. This is important to understand because not having one of the variants that 23andMe tests for does not mean that a customer does not have any risk for this kind of cancer. Additionally, this report does not look at variants associated with Lynch syndrome, which is the most common form of inherited colorectal cancer. Also, there are more than 100 variants in the MUTYH gene that are linked to MAP.

That said, the two variants included in 23andMe’s MAP report account for the majority (about 80-90 percent) of MUTYH variants in people of Northern European descent. The two variants included in 23andMe’s report are also the most prevalent in people with Northern European ancestry at between 1 and 2 percent. These variants have also been found in people of other ethnicities. Carrying both of these variants or having two copies of one of these variants increases the risk of developing colorectal cancer. If left unchecked, carrying both of these variants or having two copies of one increases the risk of developing colorectal cancer to between 43 and 100 percent. The risk for those who have just one variant is uncertain; however, some studies suggest that the colorectal cancer risk may be slightly increased, particularly for those with a family history of colorectal cancer.

The FDA clearance for 23andMe’s MUTYH-Associated Polyposis Genetic Health Risk report demonstrates substantial equivalence, through the FDA’s 510(k) pathway, to its predicate device 23andMe’s BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report.

This FDA clearance follows several years of work by 23andMe 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. Each has included an extensive FDA review process in which 23andMe submitted studies and evidence demonstrating that our reports are scientifically valid and understandable for consumers and that the results are analytically reliable.

For this newest clearance, the MUTYH-Associated Polyposis Genetic Health Risk report adhered to the same standards used in our other reports, including greater than 99 percent accuracy and utilization of key informational concepts that achieved 90 percent or greater comprehension in a demographically diverse population.