Test For Breast Cancer Gene Will Be Available In Weeks
08 March, 2018, 03:46 | Author: Arnold Gilbert
The patient simply takes a sample of his or her own saliva and tests it.
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.
The test itself is simple enough.
The market authorization for the test has been granted to the consumer genome and ancestry company, 23andMe.
However, this does not find all genes that cause cancer, the FDA cautioned. "This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk".
While at first glance the test seems like a real breakthrough and a new tool in the fight against cancer, the reality is that its impact will likely be more muted. The FDA expanded that today, adding breast cancer risk testing onto the approved list. And that can lead to cancer. And even worse, it could give some people a false sense of security and others a cause to worry for no good reason. But they're most common among people of Eastern European Jewish descent. About 45 percent of women with faulty BRCA2 genes will.
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.
The three DNA mutations searched for in the screening make up a small percentage of hundreds of known BCRA mutations.
The test is being sold by 23andMe, ...
"Being the first and only direct-to-consumer genetics company to receive FDA authorization to test for cancer risk without a prescription is a major milestone for 23andMe and for the consumer", the company's CEO Anne Wojcicki said in a release tied to the announcement. "The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors", said St. Pierre. Those decisions should be based on confirmatory tests and genetic counselling.
Along with the approval, the FDA is setting up special controls to ensure the test's accuracy and performance, the agency said. The agency also outlined special controls created to assure test's accuracy and reliability.
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