FDA OKs BRCA Consumer Test

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The FDA statement emphasized that a negative test does not rule out the possibility that a person has an increased cancer risk associated with other types of genetic mutations, including BRCA and non-BRCA mutations.

US regulators have approved the first direct-to-consumer breast cancer gene test. 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, said in a statement that the utility of the test lies in offering information to a specific population that otherwise might not get genetic screening.

It's called 23andMe, and tests for three of the more than 1,000 genetic mutations linked to breast cancer. But they're most common among people of Eastern European Jewish descent. 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.

These tests might help with prevention, but can not diagnose cancer and can not rule out your chances of getting cancer, 23andMe said.

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The 23andMe test searches for the three DNA mutations that are found most commonly in people of Jewish descent. Results also should not be used to guide treatment such as surgery or hormones, the FDA said.

Genetic testing powerhouse 23andMe announced today that it's officially received the FDA go-ahead to launch a direct-to-consumer testing kit for genes linked to various forms of cancer. For all of these reasons, it is important for patients to consult their health care professional who can help them understand how these factors impact their individual cancer risk and what they can do to modify that risk.

In addition to self-breast exams, which men and women are encouraged to do at home, there's also an at-home test approved by the Food and Drug Administration that consumers can buy. As with the first 10 tests, the company is authorized to provide the results directly to the customer.

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.