NSGC Responds to U.S. Food and Drug Administration Approval of Direct-to-Consumer Cancer Test that Reports Three BRCA Mutations

The U.S. Food and Drug Administration approved the marketing of 23andMe Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 on March 6, 2018. This is the first direct-to-consumer (DTC) test to report on three specific breast cancer gene mutations most common in people of Ashkenazi (Eastern European) Jewish descent. The National Society of Genetic Counselors commends the FDA for recognizing that these tests are limited and should not be used for medical treatment without consulting with a medical professional, such as a genetic counselor.

Genetic testing is complicated and is only one piece of the puzzle when determining one’s risk for developing a disease. Genetic counselors can guide and support patients seeking more information about their genetic health and help interpret test results. The 23andMe test detects only three out of more than 1,000 known BRCA mutations and doesn’t rule out other BRCA mutations that increase cancer risk. Consumers who test positive for these mutations need to be retested in a clinical setting under the supervision of a medical professional before moving forward with any medical decisions. Those who test negative, yet have a strong family history of cancer, may be appropriate candidates for testing and should also consult with medical professionals.

Erica Ramos, MS, CGC, NSGC President, states, “Although this test may help to identify people who have a previously undetected BRCA mutation, there are several limitations and the results may be confusing or misleading without appropriate education. Anyone who has a strong personal or family history of breast or ovarian cancer and is interested in finding out more about their individualized risk should consult with a genetic counselor to discuss their genetic testing options, or to discuss their results. Genetic counselors can help them be prepared for what the results may tell them, identify other clinical tests that may be needed based on their history and understand how those results could affect them and their relatives.”

People considering direct-to-consumer genetic testing or those who have received results and need further explanation can find a genetic counselor in their area or talk to one via phone by using NSGC’s Find a Genetic Counselor tool.

About the National Society of Genetic Counselors

NSGC is the leading voice, authority and advocate for the genetic counseling profession, representing more than 3,600 health care professionals. The organization is committed to ensuring that the public has access to genetic services. For more information, visit aboutgeneticcounselors.com


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