FDA approves first at-home test for cancer risks


A new test can predict breast cancer risk.

The US Food and Drug Administration has approved the first home test for consumers to check breast cancer risk.

"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 ability of direct-to-consumer genetic tests".

In a blog post, the American Cancer Society's chief medical officer, J. Leonard Lichtenfeld, said people with strong family histories of cancer could be misled by apparently reassuring results on such a limited test: "In short, you might be led to think you are off the hook, when the hook is still very much intact". The approval is specifically for the Personal Genome Service Genetic Health Risk (GHR) Report for the BRCA1/BRCA2 test revealing breast, prostate, and ovarian cancer risk. "Women with one of these variants have a 45-85 percent chance of developing breast cancer by age 70".

These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities, according to the FDA. The patient simply takes a sample of his or her own saliva and tests it. "I think genetic testing is best used in the context of all of your ongoing medical care".

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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.

"One thing I want people to think about is how prepared you are for this information", she said. Those decisions should be based on confirmatory tests and genetic counselling. They provide information on what the results might mean and where to get additional information. When they carry mistakes themselves, the fix isn't made, or it's made improperly.

The FDA statement emphasized that a negative test does not rule out the possibility that a person has an increased cancer risk associated with other types of genetic mutations, including BRCA and non-BRCA mutations.

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