23andMe Misses Almost 90% of BRCA Mutation Carriers

Ugh, I just read this article published on the Clearity Foundation website. 23andMe, which is FDA approved, only tested for the three most common mutations among women with a personal or family history of cancer.

Although 23andMe was not mentioned by name in the results, presented at the annual American College of Medical Genetics and Genomics recently, the study criticizes the lack of clinical utility of direct-to-consumer tests rather than criticizing the company itself.

Apparently 23andMe has been widely criticized for offering the test which gives many women a false sense of security. The FDA does caution women being tested by 23andMe that over 1,000 other BRCA mutations are not tested. That's a shockingly high number.

Of 4,700 women tested by another company, Invitae, only 12% had one of the 3 mutations tested for by 23andMe; 88% had a different mutation.

I understand why women with a personal history of breast or ovarian cancer choose to be tested by 23andMe - it's much cheaper when paying out of pocket for something their own insurance may not cover. These results should strengthen arguments to insurance companies to fully cover genetic testing.

To read the complete article, follow this link.