publication date: Aug. 8, 2014

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Daniel Hayes Leads Tour of Caris Website

Tumor profiling information Caris Life Sciences provides in its reports isn’t backed by sufficient evidence to justify some clinical decisions, said Daniel Hayes, a breast cancer expert at the University of Michigan.

Hayes, the university’s Stuart B. Padnos Professor of Breast Cancer Research and a member of a recent Institute of Medicine committee that issued a report on omics, was clicking through the Caris website as he spoke with Paul Goldberg, editor and publisher of The Cancer Letter.

PAUL GOLDBERG: Let’s start with the fundamentals.

DANIEL HAYES: I’ve been quoted many times as saying: a bad tumor marker is as bad as a bad drug. Unless we have a really high level of evidence, through two important and critical terms—(1) analytic validity, and (2) clinical utility—in my opinion, a marker shouldn’t be used to direct care.

The best examples I can think of are ER to direct endocrine therapy and HER2 to direct anti-HER2 therapy in breast cancer. There are other cancers, like KRAS for anti-EGFR antibodies, and more recently ALK mutations for crizotinib.

The issue I have with many of these companies—and I believe Caris is one of those—is that they have over-interpreted or berry-picked positive studies from many different assays that may or may not actually be predictive for a specific drug. Or, even worse, they make assumptions based on logic that a drug ought to work or not without any evidence to back up these assumptions.

As I go through their examples on the Caris website, first I see that they don’t have … Continue reading 40-32 Conversation with The Cancer Letter: Daniel Hayes Leads Tour of Caris Website

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