A group of international researchers has suggested that it’s not right to offer such genetic tests until there is strong evidence that they are valid and useful in clinical practice.
Myriad Genetics, Illumina Inc, Invitae are some of the companies which create such tests. The tests look for up to 100 inherited cancer genes, including more than 20 for breast cancer.
In June 2013, the US Supreme Court has invalidated patents held by Myraid on BRCA1 and BRCA2; this has resulted in increased popularity for such tests.
BRCA1 and BRCA2 are the genes which are believe to increase the risk of breast, ovarian and other cancers.
The researchers are actually not happy about including lesser known genes in the tests.
A breast cancer expert at Mayo Clinic in Rochester, Minnesota, Fergus Couch, said that there is no way developed so far to precisely estimate risks of mutation that occur in many of the genes on the panels.
Couch and 16 other genetic experts called for not using such panel test until they are clinical validity has been established.
Dr. Susan Domchek, breast cancer expert at University of Pennsylvania and co-author of the study said, “It’s been pretty widely assumed that all of these genes on all of these panels have clear clinical validity, meaning the genes are clearly associated with cancer. The point of this article was to say, we’re not finished with that step yet.”
Earlier this month, the US Centers of Medicare and Medicaid Services said that it is not reasonable or necessary to go for large panel tests for the BRCA genes that include genes not relevant to the patient.
The study is published in a paper on Wednesday in the New England Journal of Medicine.