FDA Authorizes First Direct-to-Consumer BRCA Mutation Test

Now they can add information about three BRCA mutations to the health reports they issue.

The test, which analyzes DNA from saliva, can only detect three out of more than 1,000 known inherited BRCA gene mutations. "The test should not be used as a substitute for seeing your doctor for cancer screening or counseling on genetic and lifestyle factors that can increase or decrease cancer risk". The test can identify three specific BRCA mutations that occur most often in people of Ashkenazi Jewish descent.

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23andMe founder and CEO Anne Wojcikci acknowledged that most cancer is not hereditary and that this test does not cover many variants tied to an even higher cancer risk. 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.

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.

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Additionally, the FDA says that this test should not substitute for a doctor visit because it doesn't account for every possible outcome. Most cancers are not caused by genetic mutations, and the ones tracked by the test aren't the most common BRCA mutations.

"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.

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The market authorization for the test has been granted to the consumer genome and ancestry company, 23andMe. "Having a negative result for this test does not mean you don't have to worry about anything else", said Elrefai. The test was reviewed through the de novo premarket review pathway. Along with this authorization, the FDA is establishing criteria, called special controls, which set forth the agency's expectations in assuring the test's accuracy, reproducibility, clinical performance and labeling. The test has the potential to provide a false sense of safety among consumers.