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23andMe Gets FDA Approval for Genetic Risk Report on Hereditary Colorectal Cancer Syndrome

NEW YORK (GenomeWeb) – 23andMe said today that it has received FDA clearance for a genetic health risk report for a syndrome associated with a higher risk of developing hereditary colorectal cancer.

The clearance enables 23andMe to report on the two most common variations in the MUTYH gene influencing MUTYH-associated polyposis (MAP), which confers a high risk for developing large numbers of pre-cancerous polyps, in turn increasing the risk for the development of CRC.

The approval also follows FDA clearance last March for 23andMe's BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report. 23andMe submitted the MAP report via the 510(k) submission pathway, through which it demonstrated substantial equivalence to the BRCA report. The FDA included both the new report and the previously authorized BRCA report in a single "cancer predisposition risk assessment system" regulation, the company noted.

As with the BRCA report, the MAP report is for over-the-counter use and is intended to be used on genomic DNA isolated from human specimens collected by the user. "The results of the test provide users with a genetic health risk assessment for developing certain cancers," the FDA states in its notification. "The test is not intended to describe a person's overall risk of developing any type of cancer nor to aid in determination of treatment or act as a substitute for recommended cancer screenings or appropriate follow-up."

23andMe noted that the MAP report is not yet available but will be offered to new and existing Health + Ancestry Service customers who have been genotyped on the company's most recent platforms. As with the BRCA1/BRCA2 report, these customers must choose whether they want to receive this information. 23andMe did not provide a timeline for commercial availability of the MAP report.

23andMe also noted that its reports include an education module to inform customers on the results and how to interpret them, as well its limitations. For example, the report will clearly state that hereditary colorectal cancers only account for about 5 percent of all CRC cases, and that it does not assess variants associated with Lynch syndrome, which is the most common form of inherited colorectal cancer.

The two variants included in the MAP report account for 80 to 90 percent of MUTYH variants in people of Northern European descent, 23andMe noted, adding that more than 100 variants in the MUTYH gene are known to be linked to MAP.

"Having two genetic variants or two copies of a variant in this report is associated with an increased risk for colorectal cancer," a 23andMe spokesperson said in an email. "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. Other factors besides the genetic variants in this report, such as age, family history, ethnicity, and more can influence your chances of developing colorectal cancer."

In addition, the spokesperson noted that if a consumer receives a "negative" or "no increased risk" result, "that does not mean you are not at risk of developing MAP or developing colorectal cancer. MAP is just one type of hereditary colorectal cancer. Furthermore, hereditary/inherited colorectal cancers only account for about 5 percent of all colorectal cancer cases."

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