Women's Health

FDA Approves Historic First At-Home Breast Cancer Genetic Test

The FDA does not recommend health decisions to be made based solely upon this test

The FDA has cautioned against using this test to make major decisions relating to one’s health. “The consequences of some things that are done can be quite substantial. That’s not to be taken lightly,” said Dr. Chanock, in reference to surgeries to remove the breasts and/or ovaries. As a result, the agency is creating ‘special controls’ in order to make the expectations of the at-home genetic test, including its accuracy, labeling, duplicability, and clinical performance – clear to the general public. The U.S. Preventive Services Task Force has also cautioned against BRCA genetic testing for women who do not have a family history of breast or ovarian cancer. “While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations, and most BRCA mutations that increase an individual’s risk are not detected by this test,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health.