FDA OKs consumer test for breast cancer genes

The U.S. Food and Drug Administration has authorized a Personal Genome Service Genetic Health Risk Report for three breast cancer gene mutations.

It is the first direct-to-consumer test to report on the mutations, which are most common in people of Ashkenazi (Eastern European) Jewish descent.

The test only detects three out of more than 1,000 known BRCA mutations and aren’t the most common BRCA1/BRCA2 mutations in the general population. That means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk.

The test analyzes DNA from a self-collected saliva sample, and the report reveals if a woman is at increased risk of developing breast and ovarian cancer.

It also describes whether a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer.

“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. But it has a lot of caveats,” 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 news release.

“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. The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk,” he said.

The FDA advises that consumers and health care professionals not use the test results to determine any treatments, including anti-hormone therapies and prophylactic removal of the breasts or ovaries.