The 23andMe test searches for the three DNA mutations that are found most commonly in people of Jewish descent.
"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".
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The FDA stresses that despite approving this first-of-its-kind test, the fact is that it only detects three out of 1,000 DNA abnormalities which can lead to cancer, so it shouldn't replace regular mammogram tests or trips to the doctor. Now they can add information about three BRCA mutations to the health reports they issue.
23andMe battled for years with the FDA over its direct-to-consumer genetic tests, and now works with the agency to do the studies that show the tests are accurate - in return for approval to market them. The test detects only three out of more than 1,000 known BRCA mutations. The test also does not provide information on a person's overall risk of developing any type of cancer. Due to the mentioned caveats, the agency indicated that patients should not exclusively rely on this test, nor should the test be used to determine a cancer treatment. "Together, BRCA1 and BRCA2 mutations account for about 20 to 25 percent of hereditary breast cancers and about 5 to 10 percent of all breast cancers", the National Cancer Institute says. Test results come in the form of a report sent to the user.
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"For all these reasons, it is important for patients to consult their healthcare professional, who can help them understand how these factors impact their individual cancer risk and what they can do to modify that risk", the statement continued. The test was reviewed through the de novo premarket review pathway.
"These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test".
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The FDA granted the marketing authorization to 23andMe.