Federal regulators have approved the first direct-to-consumer genetic test for breast, ovarian and prostate cancer risks. In a statement, the FDA said that the three mutations 23andMe's test evaluates are BRCA1/2 variants that occur most commonly in people of Ashkenazi Jewish descent.
In addition to self-breast exams, which men and women are encouraged to do at home, there's also an at-home test approved by the Food and Drug Administration that consumers can buy.
According to a release by the company, the authorization "allows 23andMe to provide customers, without a prescription, information on three genetic variants found on the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian and prostate cancer". "The variants may also be associated with an increased risk for certain other cancers". These mutations are not the most common of the BRCA mutations in the general population, the agency said.
"Most BRCA mutations that increase an individual's risk are not detected by this test", St. Pierre said. 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.
The FDA stresses that despite approving this first-of-its-kind test, the fact is that it only detects three out of 1,000 DNA abnormalities which can lead to cancer, so it shouldn't replace regular mammogram tests or trips to the doctor. Additionally, most cases of cancer are not caused by hereditary gene mutations but are thought to be caused by a wide variety of factors, including smoking, obesity, hormone use and other lifestyle issues. To win approval, the company submitted data showing its instructions and reports are easy to understand. The test was reviewed through the de novo premarket review pathway. They provide information on what the results might mean and where to get additional information. The agency also outlined special controls created to assure test's accuracy and reliability.