This story did do some very important things: including provide cost information and explaining how the test is made available. We’re unclear, though, why this story is something worth doing. There’s no evidence provided in the story to show that this test does anything to improve health outcomes for women. And it doesn’t discuss how the results aren’t always clear-cut–how are women supposed to make sense of the test? Is genetic counseling provided?
Patients who are found to carry a deleterious BRCA gene mutation are recommended to undergo more intense surveillance and potentially elective surgery due to their increased risk of breast and ovarian cancer. Patients who have been diagnosed with breast cancer and are found to carry a deleterious mutation are often counseled about bilateral mastectomy as well as having their ovaries removed due to their increased risk of additional cancers. Costs of existing tests may serve as barriers to uncovering this important information, which this story discusses. However, readers needed more information on how accurate this type of testing is, and what happens when they receive results.
The story talks about the test being $149 and that it is the most affordable test on the market.
There is no information quantifying the benefits of the test in the story. Has this type of genetic testing been shown to reduce deaths rates from breast cancer? And if so, by how much?
Also, according to research, how likely is it to accurately detect the gene? How often are the results wrong? How does it compare on that front to other tests on the market?
It is also important to stress that if a patient tests negative for a BRCA gene mutation, they are still at risk for both breast and ovarian cancer.
The BRCA gene test can help provide an estimate of risk, but a negative test does not mean that the woman is not at risk.
There are no mentions of the harms of testing and then seeking unnecessary treatment or the harms from false positives. We do appreciate that the story says clearly that not everyone should take this test:
“Medical professionals say no. The BRCA test is “absolutely not recommended for every single person,” according to Dr. Jennifer Ashton, ABC News chief women’s health correspondent.”
However, the story does not indicate if Color provides genetic counseling services to patients undergoing their test. There can be significant implications for patients and their families with both positive and negative results. In addition, the story makes no mention of the possibility of indeterminate results–some patients test for a “variant of uncertain significance,” also known as a VUS. These are detected mutations that may or may not confer an increased risk of cancer.
Genetic counseling before and after testing, ether by a certified genetic counselor or a physician with training in medical genetics, is critical to ensure that patients and their families have their results put in the proper context.
There is nothing in the story about the quality of the evidence. Was there a journal article published about the test? Did the FDA just approve the test for sale? What do we know about the evidence used for that approval?
There is no disease mongering in the story.
We liked that the story cited The U.S. Preventive Services Task Force, which brings some important balance to discussions around screening. The story also quoted the president of Morehouse University School of Medicine, Dr. Valerie Montgomery Rice. The two women with the BRCA gene who are quoted in the story appear to be independent, although often in stories like this, the company involved put the reporter in touch with the patients. It would have been nice to know how the journalist found out about the patients.
There is no comparison to alternatives.
The story made it clear that the only way to get access to the test would be through a physician. It says:
“The Color test must be ordered by a physician, either through your own doctor, or an independent physician through the company. Users are asked to send a saliva sample — which carries your D.N.A. — to their lab, where it is analyzed. Results are then sent back to the user online in three to four weeks.”
The story does not establish the novelty of the test. Why is the story important now?
The story does not appear to rely on a news release.