Of-its-kind, at-home test aims to increase early breast cancer detection

Of-its-kind, at-home test aims to increase early breast cancer detection

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. In men, the mutations also raise the risk of breast cancer, and possibly prostate cancer as well, although the research is less clear for the latter.

It noted that the test only checks for three of more than 1,000 known BRCA mutations and that a negative result does not rule out increased cancer risk.

USA regulators have approved the first direct-to-consumer breast cancer gene test. It's the first at-home BRCA1/BRCA2 screening tool to be approved for use in the USA, and could significantly raise the number of people aware of having the cancer-related mutations.

Of course, the test shouldn't be taken as the be all, end all of cancer risk - nor is it meant as a replacement for a proper screening. But those mutations are not the most common BRCA mutations in the broader population. Additionally, most cases of cancer are not caused by hereditary gene mutations but are thought to be caused by a wide variety of factors, including smoking, obesity, hormone use and other lifestyle issues. Such decisions require confirmatory testing and genetic counseling.

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The approval comes four years after the FDA threw the brakes on 23andMe's race across the consumer genetic testing landscape in a November 2013 warning letter that amounted to a cease-and-desist order.

"For all these reasons, it is important for patients to consult their healthcare professional, who can help them understand how these factors impact their individual cancer risk and what they can do to modify that risk", the statement continued. The evaluation, through the FDA's pathway for novel, moderate-risk medical devices, required greater than 99 percent accuracy and repeatability for the assay to be approved.

"I don't want to trivialize the potential for serious psychological burden that this risk information might provide; however, it is risk information that we know can lead to life saving interventions", Green said.

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