These cancer gene panel tests may be doing more harm than good by providing useless results to patients, an international group of scientists warned recently.
International researchers are opposing genetic tests that attempt to pinpoint genes linked to breast cancer, arguing that they should not be used until they have proved to be valid methods.
Several companies such as Myriad Genetics Inc., Invitae, and Illumina Inc. are marketing tests that look for 100 inherited cancer genes, 20 of them for breast cancer, and these tests have become increasingly popular since June 2013 when the U.S. Supreme Court invalidated some patents Myriad had for genes known as BRCA1 and BRCA2 that heralded high risk for breast and ovarian cancers, among others, according to a Reuters report.
It’s not those those genes that these scientists are concerned about, it’s the lesser known genes that are being packaged with them for the tests, with experts noting that the scientific community doesn’t really yet know what the risk estimates are for mutations in these genes.
In a paper published in the New England Journal of Medicine, a total of 17 genetic experts are urging against the use of panel tests until they have been validated in a clinical setting.
The U.S. Food and Drug Administration could be stepping in, as it is currently mulling how to regulate such tests, as the Clinical Laboratory Improvement Amendments of 1988 doesn’t require the tests to prove clinical validity.
While proponents say that having more genes to look at it makes it a more thorough look at a person’s cancer risk, but critics argue that it simply muddles the results and creates a number of potentially false warning flags. The scientists say that while they aren’t saying the genes aren’t important, they think the work is unfinished in making it a part of the cancer screening process.
