FDA Gives 23andMe Approval To Check For BRCA Mutations

FDA Gives 23andMe Approval To Check For BRCA Mutations

The Food and Drug Administration just approved an at-home test that allows people to check their risk of breast cancer themselves.

The three variants of the gene are found most often in people of Ashkenazi Jewish descent, with one in 40 people of that background carrying one. There is no need for a prescription to take the test.

Additionally, the FDA says that this test should not substitute for a doctor visit because it doesn't account for every possible outcome.

After DNA analysis from a self-collected saliva sample, the results then detail whether a woman is at an increased risk of developing breast and ovarian cancer and whether a man is at an increased risk of developing breast or prostate cancer.

However, this does not find all genes that cause cancer, the FDA cautioned.

It's called 23andMe, and tests for three of the more than 1,000 genetic mutations linked to breast cancer. The variants may also be associated with an increased risk for certain other cancers. The American Cancer Society says this year, it will be diagnosed in 260,000 women and a few men, and will kill almost 41,000.

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BRCA1 and BRCA2 are DNA fix genes. She works for and mentors other survivors at Carolina's Breast Friends, an organization which provides compassion and support to people going through breast cancer. Those most at risk of developing such cancers are of Eastern European Jewish descent. About 45 percent of women with faulty BRCA2 genes will.

BRCA mutations are not the only genetic mutation that raise the risk of breast or ovarian cancer.

The three DNA mutations searched for in the screening make up a small percentage of hundreds of known BCRA mutations.

US regulators have approved the first direct-to-consumer breast cancer gene test. The company submitted data on user comprehension studies, using representative GHR test reports, that showed instructions and reports were generally easy to follow and understood by a consumer.

Along with the approval, the FDA is setting up special controls to ensure the test's accuracy and performance, the agency said.

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