A Word of Caution on FDA Approved At-Home Breast Cancer Gene Testing

By: Courtney Floyd


Are at-home genetic tests a reliable screening option for hereditary cancers? 

The US Food and Drug Administration has approved a 23andMe test that screens for breast and ovarian cancer genes.

This is an exciting advancement for health empowerment, however before ordering this at-home genetic test there are a few things you should know:

  • The test only screens for three specific BRCA1 and BRCA2 mutations out of the 1,000+ known gene mutations that increase the risk for breast cancer. While the detection of a BRCA mutation on this test does indicate an increased risk, only a small population carry one of these three mutations. Most BRCA mutations that increase the risk of cancer are NOT detected with this test.
  • This test does NOT substitute evaluation by a doctor and genetic counselor. Although this test is less expensive and perhaps more convenient, the knowledge that comes with these test results is extremely limited and should not be used to make any medical treatment decisions.

“In my opinion, individuals should not have genetic testing without going through counseling from a certified genetic counselor first, so they can have all the information needed to make a fully-informed decision,” said Dr. Chrysopoulo after hearing the news. “For many, learning about a genetic mutation they carry and not knowing the potential implications can be a very difficult situation to navigate. It has implications not just for the patient, but for their entire family (in terms of health-related decision-making, planning, and health and life insurance). As if the former two aren’t enough, the latter can be financially devastating. Individuals should get tested if they want, but counseling ahead of time arms the them with the information they need to truly make the best decision for them. There are far reaching consequences of testing, both intended and unintended, that will be important for many people, but without prior counseling most folks can’t possibly realize what those are until the it’s too late. That’s a big concern for me.”

Are at-home genetic tests a reliable screening option for hereditary cancers?  | PRMA Plastic Surgery


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  • Alene Nitzky

    Thank you Dr. C and PRMA for sharing this critically important information that can be easily understood and shared. While it is tempting for many healthcare consumers to see this as an easy way to obtain information about their cancer risk, there are many other factors that must be considered around genetic testing- the first of which should be seeking the advice of a certified or licensed genetic counselor (each state has its own requirements). Many medical advances may seem to be advantageous yet they are often commercially hyped before they are really ready for judicious and beneficial use by the public. Always use caution around any new product and ask a licensed physician before you jump in!

    • PRMA

      Couldn’t agree more Alene!  Thanks so much!

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