Published: Thu, March 08, 2018
Medicine | By Rogelio Lindsey

FDA OKs BRCA Consumer Test

FDA OKs BRCA Consumer Test

The U.S. Food and Drug Administration (FDA) authorized the Personal Genome Service Genetic Health Risk Report, by 23andMe Inc., on Tuesday, which will report on three specific BRCA1/BRCA2 breast cancer gene mutations.

According to the National Cancer Institute, the three mutations are present in ~2% of Ashkenazi Jewish women compared to 0 - 0.1% in other populations.

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. These mutations are not the most common of the BRCA mutations in the general population, the agency said.

This approval is expected to raise concerns over whether or not people should ask for professional medical help, as this information may not be appropriately handled by everyone, cancer experts said.

It doesn't find all cancer-causing genes - not by a long shot, the FDA said.

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

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.

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.

The three variants of the gene are found most often in people of Ashkenazi Jewish descent, with one in 40 people of that background carrying one. 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 FDA also cautioned against using the results to make treatment decisions, such as anti-hormone therapies or the surgical removal of the breast or ovaries.

The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations.

"These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test".

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