WASHINGTON, D.C., March 8, 2018 — On Tuesday, March 6th, the U.S. Food and Drug Administration (FDA) announced approval of a direct-to-consumer genetic test for BRCA mutations, which have been linked to an increased risk of breast, ovarian, and prostate cancer. The National Breast Cancer Coalition (NBCC) is concerned about the limitations and implications of direct-to-consumer genetic testing for breast cancer and believes it is irresponsible to market and promote its widespread use at this time. Genetic testing for cancer risk is a test for a healthy population, giving most people incomplete information about their risk of getting cancer. Genetic testing has limited value in the clinical setting and should only be performed in the context of well-designed clinical trials and research studies.
Of more than 1,000 known BRCA mutations, 23andMe’s Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants) only detects three, meaning that a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk. While the detection of a BRCA mutation does indicate an increased risk for developing cancer, only a very small percentage of the general population carry one of these three mutations and, of those who do, many will never get breast cancer.
The stakes are high. The interventions available to reduce risk are not a guarantee, and come with significant health and economic risks. With no universal access to health care and continuing threats to protection against pre-existing conditions, which may include predisposition to disease, the risks could include loss of insurance, increased premiums, or medical debt. While the tests may help some women who have a strong family history and who have a BRCA1 or BRCA2 mutation make health management decisions, the available medical options are extreme, of limited value, and have serious risks and side effects that must be considered, some of which may be life-threatening.
NBCC agrees with the FDA’s recommendation that genetic testing must not be used as a screening tool because it is an unreliable indicator of true risk of developing breast cancer. Most women who get breast cancer do not have BRCA1 or BRCA2 mutations, and some women with confirmed mutations will never get breast cancer. Fran Visco, President NBCC says, “Genetic testing cannot detect, cure, or prevent breast cancer, and there are few and limited options available for those who take the test and wish to reduce their risk of developing breast cancer. The emotional and physical stakes are high; no one should undergo genetic testing without genetic counseling. But there is no structure to make that available to large segments of the public.”
Research must focus on finding safe, reliable ways to reduce cancer risk in women and men. In the future, if women and men who have BRCA1 and BRCA2 mutations can be offered viable health management options, genetic testing will become more useful.
To read NBCC’s position paper on genetic testing for breast cancer risk, please click here.
