Published: Wed, March 07, 2018
Medicine | By Earnest Bishop

Test For Breast Cancer Gene Will Be Available In Weeks

Test For Breast Cancer Gene Will Be Available In Weeks

This test is far from definitive: There are thousands of mutations on the BRCA genes alone that can raise a person's risk of developing cancer, and 23 andMe's test can only identify three. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population.

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.

"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.

TUESDAY, March 6, 2018 The first consumer test for three BRCA gene mutations associated with breast, ovarian and prostate cancer risk has been approved by the U.S. Food and Drug Administration. "But it has a lot of caveats", Donald St. Pierre, of the FDA Center for Deices and Radiological Health, said in a statement. It's the first at-home BRCA1/BRCA2 screening tool to be approved for use in the United States, and could significantly raise the number of people aware of having the cancer-related mutations.

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The test should also not be used by consumers or health care providers to decide on any treatments, including anti-hormone therapies and preventive removal of breasts or ovaries.

Robert C. Green, a medical geneticist at Brigham and Women's Hospital, said the FDA's decision was somewhat surprising, but gratifying - and a step forward in democratizing genomic information.

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. The agency also noted that most cancers do not arise from genetic mutations but more likely from a combination of factors, including lifestyle and environmental factors. In women, the presence of one of the variants increases breast cancer risk by up to 85 percent before age 70. 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. The agency also outlined special controls created to assure test's accuracy and reliability.

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