23andMe secures FDA clearance for consumer cancer test

23 January 2019 (Last Updated January 23rd, 2019 10:46)

Personal genetics firm 23andMe has obtained clearance from the US Food and Drug Administration (FDA) for the use of its new direct-to-consumer genetic test on a hereditary colorectal cancer syndrome, MUTYH-associated polyposis (MAP).

23andMe secures FDA clearance for consumer cancer test
Designed as a genetic health risk report, the test looks for the two most common genetic variants of MUTYH-associated polyposis. Credit: Pixabay.

Personal genetics firm 23andMe has obtained clearance from the US Food and Drug Administration (FDA) for the use of its new direct-to-consumer genetic test on a hereditary colorectal cancer syndrome, MUTYH-associated polyposis (MAP).

Patients with MAP are likely to develop benign colon polyps at some stage in their life, which will give them an increased risk of developing colon cancer if these polyps are not monitored closely during colonoscopies. Many patients do not find out that they have polyps until they are being medically examined for other reasons. Polyps can eventually turn malignant and result in the spread of cancer throughout the body.

Designed as a genetic health risk report, the new test looks for two most common genetic variants associated with MAP.

“The company noted that a negative result genetic with the health risk report for MUTYH variants, which include more than 100, does not indicate the absence of colorectal cancer.”

The report will be made available for the company’s existing and new Health + Ancestry Service customers.

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

“We believe improved access to genetic testing and health information will help people engage in their own health.”

The company is set to offer an educational module for customers who choose to view their MAP report. The module will provide information on the report content and directions for interpreting the results.

In addition, the company intends to provide information regarding the limitations of the report, such as hereditary colorectal cancers accounting for around 5% of all colorectal cancers.

The company noted that a negative result genetic with the health risk report for MUTYH variants, which include more than 100, does not indicate the absence of colorectal cancer.

Furthermore, the consumer cancer test does not identify variants associated with another type of inherited colorectal cancer called Lynch syndrome.

The two variants included in the MAP health risk report are said to be linked to a higher risk of developing colorectal cancer. Carrying both the variants or having two copies of one of them increases the risk by 43%-100%.

Over the years, 23andMe obtained FDA clearances for direct-to-consumer genetic tests for carrier status, genetic health risk reports, select BRCA1 and BRCA2 variants and pharmacogenetic reports.

Additional reporting by Charlotte Edwards.