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 the National Cancer Institute, the three mutations are present in ~2% of Ashkenazi Jewish women compared to 0 - 0.1% in other populations.
The decision expands the Company's Personal Genome Genetic Health Risk (GHR) Report to now detect these breast cancer mutations.
However, this does not find all genes that cause cancer, the FDA cautioned. The forthcoming kit, which will be made available without a prescription, tests for BRCA1 and BRCA2, which are linked to higher risk of ovarian, break and prostate cancer.
"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". The FDA expanded that today, adding breast cancer risk testing onto the approved list.
"The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk", he said. As the service notes, around half of BRCA carriers who offered medical history in a study don't report cancer history among immediate relatives. The test can identify three specific BRCA mutations that occur most often in people of Ashkenazi Jewish descent.
And the FDA said no doctor or patient should use the test as a basis for deciding treatment, "including anti-hormone therapies and prophylactic removal of the breasts or ovaries". For this reason, a negative test result could still mean that a person has an increased risk of cancer due to gene mutations.
Things changed in a big way in 2017 when the FDA authorized 23andMe to provide direct-to-consumer DNA testing for 10 conditions like celiac disease, Parkinson's, Alzheimer's, and more.
The test, from 23nMe, analyzes DNA from saliva collected by clients, the FDA said in an agency news release. The agency also outlined special controls created to assure test's accuracy and reliability.