The FDA Just Approved the First Home-Testing Kit to Screen for Breast Cancer Risk

Photo: Stocksy/Ivo de Bruijn

23andMe's buzzy genetic testing kit analyzes your saliva to give you a rundown on what your DNA says about your health, physical traits, and ancestry—and now the company is taking up its diagnostic reach a notch. It just released the first FDA-approved at-home testing kit for screening breast cancer risk.

But before you buy it and try it, keep in mind one pitfall of the product: According to Time, the $199 Health + Ancestry kit can now test for BRCA1 and BRCA2 genes, the presence of which indicates an increased risk of breast cancer by 45 to 65 percent. Though it seems like an easy way to gain some health-related info about your body, the test only assesses three mutations of these genes—even though more than 1,000 exist, Time reports. Furthermore, BRCA1 and BRCA2 are not the only genes to be wary of when it comes to breast cancer awareness: Multi-gene panel tests look for 25 to 50 genes that may increase the risk of breast cancer, according to the Susan G. Komen organization, a nonprofit that generates funds to find a cure for breast cancer. That means 23andMe's test could lead women to believe they don't have an increased risk when they actually do—which, TBH, is potentially more harmful than being untested and therefore unsure.

"My concern is that if an individual does this test without checking with their health-care provider and gets a negative result, that it will give them false reassurance." —Dr. Banu Arun, co-director of the clinical cancer genetics program at MD Anderson Cancer Center

"My concern is that if an individual does this test without checking with their health-care provider and gets a negative result, that it will give them false reassurance," Banu Arun, MD, co-director of the clinical cancer genetics program at MD Anderson Cancer Center, told Time. According to Dr. Arun, those three variants covered by the test are most common in people of Ashkenazi Jewish descent from Eastern Europe—but "most common" only equates to 2 percent of this population subset. In regard to the rest of the population, she said, they're even more rare, occurring in close to 0 percent.

So is this at-home test even worth trying? Robert Cook-Deegan, MD, a genomics law professor at Arizona State University, told Scientific American it's "not too bad as a screen" for women who have Ashkenazi ancestry, but "for other groups with different founder mutations—and there are many—it won’t help much. There’s a big need for users to understand that nuance."

Ultimately, it's cool that technology has advanced enough to produce at-home testing for breast cancer risk—but the 23andMe test is not a replacement for regular screenings. Especially because only about 5 to 10 percent of breast cancers are hereditary, according to; more often, cases are random or result from lifestyle factors like smoking, obesityhormone use, and exposure to toxins, the nonprofit reports.

And 23andMe is totally onboard with this sentiment, as Anne Wojcicki, CEO and co-founder of the company, noted in a statement that the kit is valuable for people who may not be familiar with their family history of cancer. But she added, "it’s important to understand that the majority of cancer is not hereditary. Our test does not account for all genetic variants that can cause a higher risk of cancer, and people should continue with their recommended cancer screenings."

If you do decide to take the home test and get an unfavorable result, talk to your doctor for detailed information and next steps. And if you get good news, don't take that as reassurance that you're safe from cancer for life—still do talk with your doctor.

In addition to having regular screenings, you should massage your breasts often to search for possible masses and practice breast self-awareness, because knowing your body goes a long way in helping you detect when you're not feeling your best.

Here's how thinking like a champion helped Olympic gymnast Shannon Miller fight cancer. Also, this is the link between endometriosis and cancer that you need to know about.

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