The Food and Drug Administration has approved the first over-the-counter home breast cancer test.
It’s not exactly over-the-counter, since it requires you to order the kit and then send in a sample of your saliva. Results return to you in a few weeks. It’s also not exactly a breast cancer test. It checks for the presence of three specific gene mutations that are associated with higher risk for developing breast cancer.
“The test only detects three out of more than 1,000 known BRCA mutations,” said the FDA in a press release. “This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk.”
The particular gene mutations checked in this test show up in about 2% of women whose heritage includes Eastern European Jewish populations. It rarely shows up for other individuals. As it happens, there are legal reasons that most of the gene mutations can’t be tested for in these home tests, so this situation is not likely to change soon.
The FDA specifically says that this test is not to be used by health professionals for diagnosis or treatment.
Understanding the limitations
Sarah Faitak, R.N., Director of the Breast Center, says it’s very important that anyone who tries a test of this kind understands what such a test can tell you — and what it can’t.
While the test accurately pinpoints a few of the mutations that correlate with increased breast cancer risk, it doesn’t even check for most of the genetic markers a thorough genetic risk assessment does.
“Getting a negative result does not mean a mutation that increases risk is NOT present”, Faitak says. “The home-based tests are not designed to find all of the mutations that might increase risk.”
What’s more, Faitak emphasizes, “A negative test does not reduce risk from personal history.” The greatest danger with a test of this kind is that many women who are at risk will get the impression that they are not. This false negative result may keep a woman from following through on important screenings.
A genetic risk assessment with a trained professional will give you a more accurate indication of the degree of risk you might face. Just 5 to 10% of American women have a hereditary form of breast cancer. Knowing if you are in the high-risk population empowers you to take the right steps to safeguard your health.
Morgan Ludwick, RN, the Lead Risk Assessment Specialist at the Breast Center, mentions that there can be unforeseen consequences for women who take this test.
Women who don’t know that they have a family history of breast cancer or who are unaware of their Ashkenazi Jewish heritage could benefit from the knowledge. Getting this information from a genetic test could let them know that they need to follow up with their physician. But this benefit comes to only a very small proportion of women who take this test… and there may be unintended consequences.
“There are emotional and family consequences that people don’t think about before doing something like this,” she points out. “Professionals need to help people understand how much stock to put into any result, let alone a direct-to-consumer test.”
Visiting the Breast Center and working with specialists to gather information and fully understand your risk level for breast cancer is very different from opening an envelope and learning that you have a higher chance of breast cancer than you realized.
“Many people think they are just doing it for fun,” says Ludwick. The test checks for many things besides risk of breast cancer. There are also different rules about privacy for tests that take place without medical supervision.
Consumer Reports recommends trying these tests only “for curiosity.” The FDA seems to agree, since they instruct that these tests should not be used to make medical decisions. If you are concerned about the hereditary risk of breast cancer, you should contact the Breast Center to schedule a risk assessment with a professional.