STATEN ISLAND, N.Y. -- Federal regulators have approved the first direct-to-consumer genetic test for breast, ovarian and prostate cancer risks.
The U.S. Food and Drug Administration (FDA) authorized the Personal Genome Service Genetic Health Risk Report, by 23andMe Inc., on Tuesday, which will report on three specific BRCA1/BRCA2 breast cancer gene mutations.
"Being the first and only direct-to-consumer genetics company to receive FDA authorization to test for cancer risk without a prescription is a major milestone for 23andMe and for the consumer," said Anne Wojcicki, 23andMe CEO and co-founder, in a press release.
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. The variants may also be associated with an increased risk for certain other cancers.
These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities, according to the FDA. About one in 40 individuals of Ashkenazi Jewish descent has one of these three variants.
Women with one of these variants have a 45 percent to 85 percent chance of developing breast cancer by age 70.
The FDA said that while this test provides detection of a BRCA mutation, only a small percentage of Americans carry one of the variants. 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," 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 an FDA press release.
SOURCE: SILIVE
