WASHINGTON – The U.S. Food and Drug Administration approved an at-home test that screens for several breast and ovarian cancer genes through the genetic testing company 23andMe. It is the first direct-to-consumer test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. The test analyzes DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. The test only detects three out of more than 1,000 known BRCA mutations and a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk. “This test provides information to certain individuals who may be at increased breast, ovarian or prostate cancer risk and who might not otherwise get genetic screening and is a step forward in the availability of DTC genetic tests” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in a statement. St. Pierre said the FDA approval comes with several caveats, and consumers and health care professionals should not use the test results to determine any treatments. The test report provides information describing what the results might mean, how to interpret results and where additional information about the results may be found. The FDA reviewed data for the test through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.
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