FDA OKs BRCA Consumer Test

Faith Castro
March 8, 2018

Today (March 6), the US Food and Drug Administration approved 23 andMe's at-home genetic test as a diagnostic tool for increased risk of breast, ovarian, and prostate cancer.

While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual's risk are not detected by this test.

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. Such decisions require thorough testing and genetic counseling, the FDA added. But those mutations are not the most common BRCA mutations in the broader population.

Of course, the test shouldn't be taken as the be all, end all of cancer risk - nor is it meant as a replacement for a proper screening. 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.

The three gene mutations are most common in people of Ashkenazi (Eastern European) Jewish descent, but are not the most common BRCA1/BRCA2 mutations in the general population.

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These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities, according to the FDA.

However, this does not find all genes that cause cancer, the FDA cautioned.

The approval comes four years after the FDA threw the brakes on 23andMe's race across the consumer genetic testing landscape in a November 2013 warning letter that amounted to a cease-and-desist order. As with the first 10 tests, the company is authorized to provide the results directly to the customer. The agency also outlined special controls created to assure test's accuracy and reliability.

Critics say this groundbreaking test likely will spark huge debate, saying anything regarding a serious disease needs to be left up to medical professionals.

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