Food and drug administration okays 23andMe home test breast cancer DNA test, with warnings
The Food and Drug Administration approved the first at-home test that consumers can buy directly to check their breast cancer risk on Tuesday.
The 23andMe test searches for the three DNA mutations that are found most commonly in people of Jewish descent. No doctor’s prescription will be needed for the test.
“These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population,” the FDA said in a statement.
The approval will likely set off a debate over whether people can handle this type of genetic information without professional help, cancer experts said.
“The test analyzes DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer,” the FDA added.
It doesn’t find all cancer-causing genes — not by a long shot, the FDA said.
“The test only detects three out of more than 1,000 known BRCA mutations. This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk.”
People shouldn’t take the test without talking to an expert, the National Society of Genetic Counselors said.
“Consumers who test positive for these mutations need to be retested in a clinical setting under the supervision of a medical professional before moving forward with any medical decisions,” the group said.
“Anyone who has a strong personal or family history of breast or ovarian cancer and is interested in finding out more about their individualized risk should consult with a genetic counselor to discuss their genetic testing options, or to discuss their results,” the group’s president, Erica Ramos, said in a statement.
Dr. Len Lichtenfeld of the American Cancer Society predicts some controversy.
“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.”
“Of this I have no doubt: this is the start of an early discussion on the value and role of genetic testing in the population at large. Who should be tested, what they should be tested for, what to do about those test results, and how to help people make the best decisions for their health care are all on the table.” he added.
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”.
“These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test.”