Test For Breast Cancer Gene Will Be Available In Weeks

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The authorisation allows 23andMe to provide customers with information on three genetic variants known to be associated with a risk for breast, ovarian, and prostate cancer.

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. Most breast cancer mutations that increase a person's risk are not detected by this test. "The use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counselor".

"This test provides information to certain individuals who may be at increased breast, ovarian or prostate cancer risk and who might not otherwise get genetic screening, and is a step forward in the availability of [direct-to-consumer] genetic tests".

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It is also estimated that only between 10 to 15 percent of women diagnosed with breast cancer have a mutation in either BRCA1 or BRCA2 gene, according to the American Society of Clinical Oncology. About 2% of Ashkenazi Jewish women have one of the mutations, but they occur very rarely in other ethnic groups, the FDA says. For the first time, the agency authorized 23andMe's test for 3 BRCA1/BRCA2 breast cancer mutations, which are most common among Ashkenazi Jews. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. Those decisions should be based on confirmatory tests and genetic counselling. Additionally, the FDA says that this test should not substitute for a doctor visit because it doesn't account for every possible outcome.

But some people will, inevitably, be blindsided by upsetting results and have to pick up the pieces with their doctors and families, Cook-Deegan said. The regulator said it reviewed data for the company's test under a pathway for low-to-moderate risk devices that are not equivalent to an already marketed device. Overall, greater access to the information is "a good thing", he said, but dealing with the fallout "is just something we will have to get used to, as a culture".

It doesn't find all cancer-causing genes - not by a long shot, the FDA said.

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