The US Centers for Medicare and Medicaid Services among other insurance companies have registered their displeasure to continue paying for panel genetic tests which they say have no links to cancer, and therefore “not reasonable and necessary.”
A team of international scientists has also discountenanced the need for any genetic tests that cannot be validated to have links to increased chances of cancers, saying most hereditary genes that patients get screened for do not predispose them to cancers, including breast cancer.
With the decision of several patients and insurance companies to stop paying for “unneeded” genetic tests, several companies that carry out such panel tests stand to lose business and patronage – and these include Myriad Genetics, Invitae, Illumina, and Ambry Genetics among others.
Most hereditary cancer genes run into hundreds, and about 20 of them tend to breast cancer including the BRCA1 gene and the BRCA2 gene.
Fergus Couch, a breast cancer expert at Mayo Clinic in Rochester, Minnesota states that that several genes tested for are relatively unknown, and that medical practitioners do not have a fool-proof way to determine the levels of mutations within the genes tested in panels.
According to a report published in the New England Journal of Medicine, several genetic experts argue that “a genomic test should not be offered until its clinical validity has been established.”
The US Food and Drug Administration (FDA) now proposes to increase its regulation of diagnostic tests conducted in labs, and it is expected that the oversight function will bring sanity into genetic testing again.
The study co-author and a breast cancer expert, Dr. Susan Domchek of the University of Pennsylvania noted that that most of the genes on panels do not have clear clinical validity, and that according to her indicates that most of the genes are not actually related to risks of cancers in patients.