companion diagnostics

CoDx the Only Way Forward for Big Pharma: John Palma, Roche Molecular


John Palma, Director of Medical Affairs, Roche Molecular

Bio and Contact Info

Listen (6:54) On demonstrating clinical value of CoDx

Listen (4:45) What is the lead time for CoDx from discovery to market?

Listen (4:11) International considerations

Listen (4:38) CoDx the only way forward for big pharma

Listen (6:54) Are you seeing more companies opt for the CoDx way?

John Palma is the Director of Clinical and Scientific Affairs at Roche Molecular. His job is to demonstrate the clinical value of the companion diagnostics that are developed at Roche. In today's interview, John gives us a "view from the trenches."

How does his team decide when to move forward on a promising biomarker? What is the lead time for CoDx compared to Rx? What are the considerations in going international? What does success look like? John addresses some practical realities for those moving pharma in the direction of personalized medicine. Will a CoDx business strategy be able to save big pharma? John says it's the only way forward.


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


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

Bio and Contact Info

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.


Toward a New Paradigm in Regulating Diagnostics: Liz Mansfield, FDA


Liz Mansfield, Director of Personalized Medicine, OIVD, FDA

Bio and Contact Info

Listen (5:04) New report on personalized medicine

Listen (1:54) How is the FDA handling CoDx associated with breakthrough therapies?

Listen (1:52) Is the FDA open to seeing the use of POC tests as CoDx?

Listen (5:11) How much authority do you actually have?

Listen (3:10) Regulating whole genome tests

Listen (2:00) Are we headed to a world of CoRx?

Listen (5:35) Moving toward a new paradigm of diagnostics regulation

We're happy to have Liz Mansfield from the FDA to the program as part of our series on CoDx. Liz is Director of Personalized Medicine in the Office of In Vitro Diagnostics.

The symbiotic relationship between business and regulation has been part of our American history from the days of the railroads to the present age of genomic medicine. New technology is constantly presenting difficult questions to the public, opportunities for business, and challenges for regulators. For example, there are a slew of new point-of-care tests coming on the market. How open is the FDA to seeing these tests used as CoDx? And how is the regulatory body preparing to evaluate a test on 3 billion base pairs, a whole human genome. Some wonder if the FDA will lose its relevance in the genomic age when there are vast amounts of data floating around and a whole genome test is easily available.

In today's interview, Mansfield chips away at these questions with confidence and a certain amount of humility in the face of the coming technologies. Unable to say whether any company has yet sought approval on a whole genome test, she does say that the team at FDA is preparing for such time.

"We've seen this coming," she says. "Huge amounts of data can be drawn out of a single sample. And we've had to come up with a new paradigm for regulation where we're not to look at each individual measurement so closely. We're going to have to ask for representative measurements and trust those more than we have in the past."


Editor's Note: Our apologies for the static in the interview. Liz was on an internet phone at her office and there is slight interference. Also, since this show was published, the FDA cleared a Dx Assay on Illumina's MiSeq platform (Nov 20, 2013).

Alan Mertz Sells Personalized Medicine on Capitol Hill


Alan Mertz, President, ACLA Bio and Contact Info

Listen (6:28) Revolution in healthcare colliding with terrible time in the Capitol

Listen (5:54) A growing recognition of personalized medicine in Washington

Listen (6:16) Story of the recent CPT code change

Listen (4:40) Are there still labs that are not being paid for MoDx tests?

Listen (3:01) What is your message to Dx industry?

Today we begin a new series, Going the Companion Diagnostics Way. We’ll be looking at issues around reimbursement, regulation, and development of diagnostics in conjunction with a therapeutic. Talk to anyone in the world of diagnostics, and they’ll tell you the big challenge is reimbursement. And things are getting even worse. Recently Medicare has changed the way tests are reimbursed, but the change has been ineffective and left many testing labs without any reimbursement for several months this year.

Here to talk to us about the Medicare issue and about reimbursement and personalized medicine in general is Alan Mertz. He’s the president of the ACLA or American Clinical Laboratory Association who represents the nation’s leading clinical labs. This means that Alan is the salesman for molecular diagnostics on Capitol Hill. Hear in this interview Alan's summary of the Medicare debacle with new CPT codes and his message to those in the industry going forward.


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