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ibusinesslines.com December 09, 2018


FDA Approves 1st Home Test for Breast Cancer Genes

07 March 2018, 04:15 | Melissa Porter

A 23and Me kit Lydia Ramsey Business Insider

23andMe kit

The newly authorized test identifies three of 1000-plus mutations associated with breast cancer risk. No doctor's prescription will be needed for the test. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population.

The test is fairly straightforward.

The test analyzes DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer.

So, while it is unclear what policy shift caused the FDA's recent change of heart, the announcement it published is jam-packed with caveats, highlighting the limitations of 23andme's now approved DTC test.

"The test only detects three out of more than 1,000 known BRCA mutations".

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.

"This test provides information to certain individuals who may be at increased breast, ovarian or prostate cancer risk and who might not otherwise get genetic screening, and is a step forward in the availability of [direct-to-consumer] genetic tests".


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.

Around one in 400 people have BRCA mutations that can cause cancer, and is more common among those with eastern European or Jewish descent. The American Cancer Society says this year, it will be diagnosed in 260,000 women and a few men, and will kill almost 41,000.

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

"For some people who might be getting this test, it might be hard for people to interpret and understand those results".

The FDA says the test is not a substitute for regular medical checkups and should not be used to make any medical decisions. The agency also outlined special controls created to assure test's accuracy and reliability.



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