When Mara Aspinall, president of Ventana Medical Systems, a member of the Roche Group, talks about companion diagnostics, she isn't talking company line. She is talking passion. She is talking action. And yes, she is talking business.

Aspinall brings an urgent zeal to her workplace where she leads a team charged with an exalted corporate goal: to improve the lives of all patients afflicted with cancer.

A member of the former Advisory Council on Genetics in the Obama and Bush administrations, and a co-founder of the European Personalized Medicine Association, Aspinall assumed her Ventana post in September 2011 and already has spearheaded important collaborations between Ventana and major players - including Pfizer, Bayer, Aeterna Zentaris, Syndax - to further the cause of personalized medicine through companion diagnostics.

Aspinall offers ADVANCE readers her perspectives on the emergence of personalized medicine and the vital role of laboratory diagnostics and professional diagnostic teams.

ADVANCE: Can you give us a basic definition of "companion diagnostics" since it's a relatively new term, and tell us what it means to laboratorians?

ASPINALL:  Certainly. The FDA defines companion diagnostics as a device that identifies or determines a condition of use for a therapeutic product and is important to ensure the safe and effective use of that product.

So, companion diagnostics is the ability to use testing to subdivide patients. The result of that testing is what is casually considered a sub-type of a disease, not just "a disease."  In my mind personalized healthcare is all - fundamentally and foundationally -- about the diagnostic. There would be no personalized healthcare without it. So it is putting the lab professionals at the central position to say what the real, detailed diagnosis of a patient is. It is not good enough to say a patient has "cancer." 

ADVANCE: Can you explain why "it is not enough to say 'cancer'"?

ASPINALL:  I have a wonderful chart that examines blood cancers over the last hundred years. The chart shows that 100 years ago there were two known types of blood cancers - lymphoma and leukemia. That was it. Today we have identified 105 lymphomas and leukemias. So it is clearly not good enough to identify just "cancer," or "lymphoma" or "leukemia." It needs to be a much more specific diagnosis and the power to make that happen is in the lab professionals' hands. I'm so excited about that!

ADVANCE: Is it safe to say that companion diagnostics dig down to the most elemental level of disease?

ASPINALL:  Yes. It's typically defining the genes or the proteins of the tumor, or of the patient. I think increasingly it will be an even broader array of biomarkers; I do believe each day it expands in terms of how we are defining that. We're starting to find that a biomarker in the broadest sense can be any marker for biological activity that helps define the status of the patient. This really opens up the world. What's important to understand is that is it's not about one type of test. It's about a broad array of tests.

ADVANCE: Does this mean we're in the brink of a brave new world in the marriage of diagnostics and care?

ASPINALL:  Yes. Absolutely. I believe that is the next great transformation of medicine. It's all about getting that diagnosis right at the most specific level possible because without it we cannot use the great therapeutics that exist today. At Ventana our mission is to improve the lives of patients afflicted with cancer and our passion is exactly the same, but to do it with diagnostics.

ADVANCE: How has this changed what used to be "business as usual"?

ASPINALL:  Specifically it means pharma and biotech are embracing this idea. The same couldn't be said five years ago when it was not being broadly embraced throughout the industry. Now I can tell you many, many of the pharmaceutical companies and biotech companies that we work with and talk to are creating an opt-out program, not an opt-in. They embrace this idea so aggressively that they are assuming all of their compounds will have a companion diagnostic associated with it. That's the real change that has happened in the last 3-5 years.

ADVANCE: Will this require a new mindset for medical professionals?

ASPINALL:  As companion diagnostics evolve, laboratories will need to keep up with new advances of technologies. It means working with the pathologist to ensure laboratorians understand the wider array of technologies. Digitalization, imaging components and IT components will be more aggressively used going forward as well.

I do think we have to train oncologists and other treating physicians to understand implications of these tests. The treating team, which should include the pathologist, needs to adapt. A key piece to success is changing how physicians think about handling a patient and in their recognizing that the diagnostics team plays a more and more important role. The diagnostics team should be part of that treating physician team.

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