23andMe Just Got FDA Approval for Rare DNA Cancer Test

We’ve all seen the commercials – especially during the holiday season – for home DNA kits like 23andMe and Ancestry DNA, where a saliva sample can unlock your family heritage.

But what started as a fun way to dig into your family tree has blossomed into a nifty diagnostic tool that is poised to help many – especially in the rare disease community.

Just last week, 23andMe announced it was given the green light from the Food and Drug Administration to offer consumers a test for hereditary colorectal cancer.

Specifically, it will now be able to tell customers whether they have two genetic variants that influence MUTYH-associated polyposis (MAP), a rare condition associated with an increased risk of colorectal cancer.

What is MUTYH-Associated Polyposis?

MAP is a rare, hereditary condition characterized by multiple polyps in the colorectum. The known genetic cause is mutations in the MYH gene.

People with MAP are at an increased risk of developing colon and rectal cancer. The majority of colon cancers will occur between the fifth and seventh decade of life. An estimated 50% of people with MAP will have colorectal cancer at the time of diagnosis.

Burgeoning New Diagnostic Tech

This actually marks the second test associated with cancer risk for which 23andMe has received FDA clearance. Last March, the company began offering a report on three genetic variants associated with increased risk of breast cancer in the BRCA1 and BRCA2 genes.

And while there is broad concern about such tests being offered to consumers directly, without a doctor or genetic counselor to help interpret results and plan any medical care accordingly, this new direction is certainly an indication that the technology and ease of diagnosis will be more common as the months and years roll by.


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