Direct-to-consumer cancer risk test gets FDA approval


However, the test is limited in that it can only assess 3 mutations of breast cancer, most often only found in individuals of Ashkenazi (Eastern European) Jewish descent.

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.

The FDA's director of the Office of In Vitro and Radiological Health, Donald St. Pierre noted that the test has a lot of caveats. Now they can add information about three BRCA mutations to the health reports they issue. In men, the mutations also raise the risk of breast cancer, and possibly prostate cancer as well, although the research is less clear for the latter. However, even prescription-ordered genetic testing is not 100% conclusive that a person will develop cancer or not. Those decisions should be based on confirmatory tests and genetic counselling. That service ended after the FDA got involved, however, with the administration citing concerns about providing that sorts of info to individuals who may not have any medical training.

There are over 1000 known BRCA mutations so a negative test result does not rule out the possibility that an individual carries other BRCA mutations.

The FDA said that while this test provides detection of a BRCA mutation, only a small percentage of Americans carry one of the variants.

The three BRCA1/BRCA2 hereditary mutations detected by the test are present in about 2 percent of Ashkenazi Jewish women, according to a National Cancer Institute study, but rarely occur (0 percent to 0.1 percent) in other ethnic populations. 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. To win approval, the company submitted data showing its instructions and reports are easy to understand. At this time, the FDA is also establishing special controls that outline the agency's expectations for accuracy, reproducibility, clinical performance, and labeling.

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