Researchers, patients rise up against gene tests for breast cancer not linked to risks
Patients, helped by a team of international researchers have risen up against paying for genetic tests that are not directly linked to breast cancer, saying such tests are not necessary and completely unvalidated in the light of ongoing researches.
According to a report published in the New England Journal of Medicine, the researchers emphasized that “a genomic test should not be offered until its clinical validity has been established.”
This initiative will affect a number of companies such as Ambry Genetics, Illumina, Myriad Genetics Inc., and Invitae Inc. among others who carry out such tests for as much as 100 inherited cancer genes – and even over 20 for breast cancer.
The BRCA1 and BRCA2 inherited cancer genes are the most dangerous for developing breast cancer, ovarian cancer, and other related cancers; but the patient for tests on this has held by Myriad Genetics Inc. was invalidated by the US Supreme Court in June 2013.
“The reality is that we don’t have good risk estimates for mutations that occur in many of the genes on the panels,” said Fergus Couch, a breast cancer expert at Mayo Clinic in Rochester, Minnesota.
The FDA is now set to regulate diagnostic tests in labs, and these include many genetic tests.
It is true that genes that are not much known can provide essential data for determining cancer risks, but medical experts and even patients do not often know what the results of the tests actually mean.
“It’s been pretty widely assumed that all of these genes on all of these panels have clear clinical validity,” said Dr. Susan Domchek, a breast cancer expert at the University of Pennsylvania. “The point of this article was to say, we’re not finished with that step yet.”
The US Centers for Medicare and Medicaid Services among many insurance companies say panel tests for BRCA1 and BRCA2 cancer genes “are not reasonable and necessary,” and they would not be paying again for such tests when carried out by patients.