Is the Dx Industry Ready to Quit this Vicious Cycle? Asks Oncologist


Dan Hayes, Clinical Director, Breast Oncology Program, U of Michigan Cancer Center

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Listen (4:27) A vicious cycle

Listen (3:07) Why don't we value Dx as we do Rx?

Listen (3:31) Three key terms for turning things around

Listen (5:05) CoDx a step forward, but regulation for all tests is needed

Listen (6:44) Have you seen more companies going the CoDx way?

Listen (3:21) A cultural problem?

Listen (5:49) The days of doing LDTs are past

Why aren't diagnostics valued as highly as therapeutics? Often a diagnostic or prognostic test such as the popular OncoTypeDx sold by Genomic Health can protect patients from undergoing unnecessary drug therapy. This saves money throughout the medical system and most importantly, the patient benefits. So why, when drugs often sell at tens of thousands, even hundreds of thousands of dollars per year, are the diagnostics sold so cheaply?

Dan Hayes is an oncologist at the University of Michigan Cancer Center. He's also the co-author on a recent paper, Breaking the Vicious Cycle. Specifically, Dan and his coauthors are addressing this value issue with tumor biomarker tests. But the paper is really a referendum on the diagnostics industry as a whole.

Dan and his colleagues say there is not one single problem, but that the industry is in a vicious cycle that leads to the undervaluing of the tests. In today's interview, Dan goes over the various "nodes" of the cycle (uneven regulation, reimbursement, publications, etc.) and articulates some of the practical suggestions for breaking the cycle.

Is the diagnostics industry ready to grow up and go the same route as the drug industry? It has to, Dan insists.

"The days of academic labs doing LDTs are past," he says.

Podcast brought to you by: Myraqa Clinical Research: The CRO for Point of Care and PMA Diagnostics.