23andMe’s Direct-To-Consumer Genetic Cancer Risk Test Receives FDA Nod

23andMe’s Direct-To-Consumer Genetic Cancer Risk Test – FDA Approved

The first direct-to-consumer DNA test for three BRCA1/BRCA2 breast cancer gene mutations has now received the federal approval.

The genetic testing powerhouse 23andMe is now all set to launch the testing kits. The forthcoming kit, which will be made available without a prescription, tests for BRCA1 and BRCA2, which are linked to higher risk of ovarian, break and prostate cancer.

“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,” the company’s CEO Anne Wojcicki said in a release tied to the announcement. “We believe it’s important for consumers to have direct and affordable access to this potentially life-saving information. We will continue pioneering a path for greater access to health information, and promoting a more consumer-driven, preventative approach to health care.”

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. This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk.

Studies suggest that some 1 in 40 people of Ashkenazi descent has one of these three variants, Shirley Wu, 23andMe’s director of product science said, and women with one of the variants have a 45 percent to 85 percent chance of developing breast cancer by age 70. The genes also suggest a higher risk of ovarian cancer in women, and breast cancer in men.

“Traditionally you only would get tested for BRCA if you have a family history of cancer” said Wu. “We are providing a test people at risk that otherwise would have been missed. This is a giant step forward for consumers in giving them direct access.”

“The 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 direct-to-consumer 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 F.D.A.’s Center for Devices and Radiological Health.

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

The FDA announcement stresses that the results of the tests are limited in scope, do not mean other cancer-causing gene mutations are not present, and should not be used to determine treatments without other testing and genetic counseling.

Still, 23andMe’s new testing kit could serve to show the potential benefits and risks of at-home testing, and it may serve as an important stepping stone on the path to comprehensive tests to determine a person’s risk of developing cancer and other health conditions.