There's an at-home test for breast cancer mutations. Should you take it?
The Food and Drug Administration has approved the first at-home test people can use to get genetic information about their risk for breast cancer, potentially setting the stage for more do-it-yourself medicine in the future.
But, breast cancer experts caution, it is still important to get an expert to interpret the results and have mammogram screenings on a regular basis.
The $199 kit — from 23andMe, a California-based personal genomics and biotechnology company — analyzes a person's saliva.
When sending the information, people must ask that their saliva be analyzed for breast cancer genes or ovarian cancer genes, the FDA said in a news release. The test also can be used to check men for risk of developing breast or prostate cancer.
The test specifically identifies whether a person has any of the three BRCA1/BRCA2 breast cancer gene mutations that are the most common in people of Ashkenazi — Eastern or Central European — Jewish descent. There are 1,000 known BRCA mutations. BRCA1/BRCA2 mutations identified by the test are present in about 2 percent of Ashkenazi Jewish women, the National Cancer Institute said.
Dr. Jane Raymond, a medical oncologist at Allegheny General Hospital, said the 23andMe test is a small piece of the puzzle and questions remain about what people will do with the results. She said she expects a lot of people will order the kit.
“This serves a small portion of the population,” said Raymond, adding that it's important for people to know their family history of breast cancer.
“But, if you have a strong history of breast cancer, it doesn't necessarily mean you have a predisposition,” she said.
According to the American Cancer Society, about 266,120 new cases of invasive breast cancer will be diagnosed in women in the United States this year.
“This authorization is incredibly valuable for those who might not be aware of their Ashkenazi Jewish descent or aren't familiar with their family history of cancer,” Anne Wojcicki, 23andMe CEO and co-founder, said in a statement. “But it's important to understand that the majority of cancer is not hereditary, our test does not account for all genetic variants that can cause a higher risk of cancer, and people should continue with their recommended cancer screenings.”
A report in the New York Times said the FDA required 23andMe to add a warning statement explaining the test's limitations, as well as the fact a negative test does not rule out other genetic mutations associated with cancer risk. Also, the warning says test results should not be used to determine medical treatment.