This test is far from definitive: There are thousands of mutations on the BRCA genes alone that can raise a person's risk of developing cancer, and 23 andMe's test can only identify three.
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Experts are also warning consumers and doctors not to use the test results to make any treatment decisions and that a negative test does not mean they don't have other genetic or lifestyle factors that could increase their risk of cancer.
This test analyzes a sample of saliva and screens for three mutations of the BRCA1 and BRCA2 genes. That accounts for a small percentage of people.
But "it has a lot of caveats", warned Donald St. Pierre, acting director of the FDA's Office of In Vitro Diagnostics and Radiological Health. But those mutations are not the most common BRCA mutations in the broader population. "The variants may also be associated with an increased risk for certain other cancers".
She said that although the company hasn't yet announced specific cancer risk mutations that it will add in the future, the approval surmounts a major hurdle.
"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 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.
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 agency also outlined special controls created to assure test's accuracy and reliability. As with the first 10 tests, the company is authorized to provide the results directly to the customer.
The FDA granted the marketing authorization to 23andMe.