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m3n4.net December 17, 2018


FDA Approves 1st Home Test for Breast Cancer Genes

10 March 2018, 01:27 | Louis Holland

FDA Approves 1st Home Test for Breast Cancer Genes

The FDA announced it will allow the genetic testing company 23and Me to market directly its breast cancer test that will help assess 3 mutations in a common form of breast cancer gene

Still, the company, which already tests DNA for other health risks as well as ancestry, said this cancer test is "a step in the right direction".

The three variants in the BRCA1 and BRCA2 genes are associated with a significantly higher risk of breast and ovarian cancer in women, and breast cancer in men. About 1 in 40 individuals of Ashkenazi Jewish descent has one of these three variants. The FDA has since allowed the company to test for a few genetic mutations linked to health risks, including some for Alzheimer's and Parkinson's. The test looks for three mutations. "This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk".

23andMe has received the first FDA authorisation for a direct-to-consumer genetic test for cancer risk. Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a statement that the utility of the test lies in offering information to a specific population that otherwise might not get genetic screening. Furthermore, only a small percentage of Americans carry one of these 3 mutations.

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USA consumers soon will be able to test themselves at home for some genetic mutations that increase the risk of breast, ovarian and prostate cancer - but you might want to think before you spit.

People shouldn't take the test without talking to an expert, the National Society of Genetic Counselors said.

Critics say this groundbreaking test likely will spark huge debate, saying anything regarding a serious disease needs to be left up to medical professionals. But, of course, the results of the test should in no way be taken as a replacement for a visit to the doctor.

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But in a flawless world, a discussion with a medical provider would still happen first, before someone decides whether to get tested and which tests to take, said Susan Domchek, an oncologist who directs the Basser Center for BRCA at the University of Pennsylvania. To win approval, the company submitted data showing its instructions and reports are easy to understand.

The FDA says those three hereditary mutations occur in about two percent of Ashkenazi Jewish women, but rarely in anyone else.

It is estimated that less than one percent of the general population has a mutation in either of BRCA1 or BRCA2.

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It is estimated as well that only 5 to 10 percent of cancer is caused by gene mutations inherited from a parent.



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