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

For the first time, the agency authorized 23andMe's test for 3 BRCA1/BRCA2 breast cancer mutations, which are most common among Ashkenazi Jews.

The drug regulator said the test, which work by analyzing DNA collected from saliva samples, provides genetic risk information but can not determine a person's overall risk of developing a disease or condition.

The newly authorized test identifies three of 1000-plus mutations associated with breast cancer risk.

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The Personal Genome Genetic Health Risk Report was first approved last April to provide information for a broad range of genetic disorders. 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. However, even prescription-ordered genetic testing is not 100% conclusive that a person will develop cancer or not. The test should not be used as a substitute for regular cancer screenings, he said. The use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counselor. These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities.

Around one in 400 people have BRCA mutations that can cause cancer, and is more common among those with eastern European or Jewish descent.

The FDA said that while this test provides detection of a BRCA mutation, only a small percentage of Americans carry one of the variants. 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. The test report provides information describing what the results might mean, how to interpret results and where additional information about the results may be found. That service ended after the FDA got involved, however, with the administration citing concerns about providing that sorts of info to individuals who may not have any medical training. The agency also outlined special controls created to assure test's accuracy and reliability.

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