FDA gives nod to 23andMe for no-prescription breast cancer gene testing

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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.

The three mutations detected by the test occur in about 2 percent of Ashkenazi Jewish women, but only 0 to 0.1 percent of other ethnic groups, according to the U.S. National Cancer Institute.

"The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk", he said.

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"Some of the uses for which PGS is intended are particularly concerning", the FDA writes, "such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these". "But it has a lot of caveats", Donald St. Pierre, of the FDA Center for Deices and Radiological Health, said in a statement.

About 1 in 40 individuals of Ashkenazi Jewish descent has one of these three variants.

Erica Ramos, the organization's president, said, "Anyone who has a strong personal or family history of breast or ovarian cancer and is interested in finding out more about their individualized risk should consult with a genetic counselor to discuss their genetic testing options, or to discuss their results".

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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.

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.

The market authorization for the test has been granted to the consumer genome and ancestry company, 23andMe. The test was reviewed through the de novo premarket review pathway. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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