On March 6, “F.D.A. Approves First Home Testing for 3 Breast Cancer Mutations, With Caveats” ran in the New York Times:
“The Food and Drug Administration for the first time has authorized a genetic testing company to offer screenings for three breast cancer mutations common in Ashkenazi Jews, giving consumers the ability to initiate testing at home and see results without talking to a doctor or counselor.” – as reported by Roni Caryn Rabin.
Below, Dr. Generosa Grana, Director of MD Anderson Cancer Center at Cooper; and Brooke Levenseller Levin, MS, LCGC, and Kristin DePrince Mattie, MS, LCGC, Licensed Genetic Counselors with the William G. Rohrer Cancer Genetics Program of MD Anderson Cancer Center at Cooper, share their comments on the release of this news.
For more information about genetic counseling, including information related to the Cancer Genetics Program at MD Anderson Cancer Center at Cooper, please click here.
“This continues the dissemination of genetic information into the public arena and likely represents the tip of the iceberg. But testing for disease-associated genes is a very different issue than knowing information about ones ancestry.
“I am seriously concerned about having this information delivered to an individual with no preparation. Genetic counseling prior to and following testing is critical to prepare patients for the results of tests such as these that, if positive, predict risk of disease (breast, ovary, prostate, pancreatic cancer and melanoma). The implications are significant for both the person being tested and for their family members.
“Based on these results the person who tests positive needs to begin to consider decisions regarding cancer screening, preventative surgery and lifestyle modification- all factors to decrease risk of developing cancer or increasing the odds of early diagnosis.
“Population based screening has been discussed and research studies are being done in the U.S. looking at issues related to it.
“As a clinician involved in the management of individuals and families who carry these genetic abnormalities, I believe this preparation is critical. The emotional response that these results can impart and the seriousness of the discussions that must follow obtaining the results are very significant. Preparation of individuals before testing and medical guidance once results are available is critical to support individuals in making meaningful use of these results. It is important to note that the FDA recommends confirmatory clinical testing and genetic counseling for patients who undergo the 23andMe testing:
“Consumers and health care professionals should not use the test results to determine any treatments, including anti-hormone therapies and prophylactic removal of the breasts or ovaries. Such decisions require confirmatory testing and genetic counseling.” (Click here for full statement from FDA)
“Only three specific BRCA1 and BRCA2 gene mutations which are most common in people of Ashkenazi (Eastern European) Jewish descent are to be reported at this time by 23andMe. However, these results do not represent full analysis of these two genes or include analysis of any other genes that may play a role in hereditary cancer risk. It is critical that non-Jewish individuals not misinterpret a negative 23andMe result and forego needed comprehensive genetic testing.”
Generosa Grana, MD, FACP
Director, MD Anderson Cancer Center at Cooper
Hematologist/Medical Oncologist
Brooke Levenseller Levin, MS, LCGC
Licensed Genetic Counselor
William G. Rohrer Cancer Genetics Program, MD Anderson Cancer Center at Cooper
Kristin DePrince Mattie, MS, LCGC
Licensed Genetic Counselor
William G. Rohrer Cancer Genetics Program, MD Anderson Cancer Center at Cooper