FDA greenlights 23andMe's direct-to-consumer breast cancer gene test

Genetic testing company 23andMe's direct-to-consumer breast cancer test, which screens for three specific gene mutations, received FDA approval March 6.

Here are four things to know.

1. The test is the first to report on three specific BRCA1 and BRCA2 breast cancer gene mutations that are most common in people of Eastern European Jewish descent. The test only detects three out of more than 1,000 known BRCA mutations.

2. 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, warns that while the test can detect increased risks of cancer, it has a lot of caveats.

"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.

3. The test, called the Personal Genome Service Genetic Health Risk Report, analyzes DNA gathered from a self-collected salvia sample to determine if a patient is at increased risk of developing breast cancer.

4. 23andMe proved the test was accurate and could provide reproducible results, according to the FDA's review of the test.

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