publication date: Aug. 8, 2014
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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