Researchers Oppose Unvalidated Gene Panel Tests for Cancer Links

“A group of international researchers is making the case that genetic tests that look for multiple hereditary genes suspected of being linked to breast cancer should not be offered until they are proven to be valid and useful in clinical practice.

“Such tests, made by several companies including Myriad Genetics Inc, Ambry Genetics, Invitae and Illumina Inc, cover up to 100 inherited cancer genes, including more than 20 for breast cancer.

“They have become increasingly popular since June 2013, when the U.S. Supreme Court invalidated patents held by Myriad on BRCA1 and BRCA2, two well-characterized genes that put a woman at high risk for breast, ovarian and other cancers.

“What the researchers are concerned about are lesser-known genes included in the tests.

” ‘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.”