The test looks for three mutations. Most BRCA mutations that increase an individual's risk are not detected by this test. It can not determine a person's overall risk of developing cancer.
The three variants in the BRCA1 and BRCA2 genes are associated with a significantly higher risk of breast and ovarian cancer in women, and breast cancer in men. And FDA warned that the tests, which work by analyzing saliva samples, carry significant risks for individuals if they are used without consulting a doctor or genetic counselor. Mutations in these genes raise a person's risk for breast, ovarian, and prostate cancer.
In a prepared statement, 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, called the approval a step forward with "a lot of caveats". Due to the mentioned caveats, the agency indicated that patients should not exclusively rely on this test, nor should the test be used to determine a cancer treatment. The agency advises that patients and providers should not use the GHR report to determine the course of treatment, as these decisions require further testing and genetic counseling, according to the release.
Around one in 400 people have BRCA mutations that can cause cancer, and is more common among those with eastern European or Jewish descent. "Having a negative result for this test does not mean you don't have to worry about anything else", said Elrefai.
The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations.
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.
BRCA1/BRCA2 test has been authorized by the Food and Drug Administration (FDA). These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test. Test results come in the form of a report sent to the user.