Direct-to-consumer cancer risk test gets FDA approval

23andMe

For the first time the FDA has granted permission to market a direct-to-consumer genetic test to check for BRCA mutations that are associated with breast and ovarian cancer.

To take the test, you simply check a box and mail in your saliva, but doctors warn, it won't test everyone, saying it only searches for three DNA mutations that are found most commonly in the Ashkenazi (Eastern European) Jewish ancestry.

This test analyzes a sample of saliva and screens for three mutations of the BRCA1 and BRCA2 genes.

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BRCA1/BRCA2 test has been authorized by the Food and Drug Administration (FDA). The variants also are associated with ovarian cancer in women and breast and prostate cancer in men.

In a prepared statement, Donald St. Pierre, acting director of the office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, called the approval a step forward with "a lot of caveats". These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities. The test only detects three out of more than 1,000 known BRCA mutations. The FDA cautions that a negative result from the test doesn't rule out that a person has other BRCA mutations or an increased risk of cancer.

BRCA mutations account for about 50 percent of hereditary breast cancers and up to 65 percent of those who inherit the mutations will develop breast cancer. 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 addition to testing, it is important for patients to discuss cancer risk related to lifestyle factors with their providers, according to the release. As part of the process, the FDA examined user comprehension data, using representative GHR test reports showing instructions and reports were generally easy to follow for the consumer. The data were reviewed through the de novo premarket review pathway. They provide information on what the results might mean and where to get additional information.

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