Published: Thu, March 08, 2018
Medical | By Vernon Walton

FDA approves first at-home test for cancer risks

FDA approves first at-home test for cancer risks

"These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population", the FDA said in a statement.

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

Approval of this testing a big step forward in the availability of genetic tests for consumers, but there are more than 1,000 BRCA mutations and this test does not screen for the ones that are most commonly associated with a higher risk of cancer in Americans.

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. 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. Such decisions require thorough testing and genetic counseling, the FDA added. 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. And FDA warned that the tests, which work by analyzing saliva samples, carry significant risks for individuals if they are used without consulting a doctor or genetic counselor.

BRCA1 and BRCA2 are DNA fix genes.

If it comes back positive for any of the three genetic mutations, like BRCA, the patient is instructed to see a doctor. Those most at risk of developing such cancers are of Eastern European Jewish descent.

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

Women with one of these variants have a 45 percent to 85 percent chance of developing breast cancer by age 70.

BRCA mutations are not the only genetic mutation that raise the risk of breast or ovarian cancer.

The test should also not be used by consumers or health care providers to decide on any treatments, including anti-hormone therapies and preventive removal of breasts or ovaries. The company submitted data on user comprehension studies, using representative GHR test reports, that showed instructions and reports were generally easy to follow and understood by a consumer.

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