What a New FDA-Approved “At-Home” Cancer Test Really Means

23andMe’s genetic screening isn’t a panacea for your health

By Kirk Miller

 
23andMe Cancer Test
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08 March 2018

It was just last week that we posited that men who don’t like to go to the doctor can now take a bunch of much-needed medical tests at home.

And now there’s one more, and it’s a biggie: A test for cancer.

Consumer genomics company 23andMe, which at one point halted its genetic health tests after warnings from the US Food and Drug Administration, has been granted FDA approval for a direct-to-consumer test for certain cancers.

“The authorization allows 23andMe to provide customers, without a prescription, information on three genetic variants found on the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian and prostate cancer,” the 23andMe site notes.

The test will be administered in pretty much the same way as other at-home screenings: order a kit, send in a saliva sample and then see your results. (To get an idea of what the kit could look like, see 23andMe's current genetics test below.)

But even the FDA notes are a lot of "caveats" to this process: The test only detects three out of more than 1,000 known BRCA mutations. A negative result doesn’t mean you aren’t carrying a different BRCA mutation. And only a small percentage of Americans carry one of the screened mutations — basically, they’re present in about two percent of Ashkenazi Jewish women, and less than 0.1 percent of other ethnic populations.

“The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk,” says Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

But consider this an important first step: it allows for screening for people who may not normally have access to this kind of information. And it (most likely) will be a cheaper, more convenient process than going to the doctor.

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