Companion Diagnostics – Regulatory Improvements, Market Trends and Emerging Technologies Podcast Transcript

Amid Zand:
Hey everyone. Welcome to the podcast from Cambridge Healthtech Institute for the Sixth Annual Next Generation Diagnostics Summit which runs from August 19th to 21st in Washington DC.

My name is Amid Zand and I'm an associate conference producer at Cambridge Healthtech Institute. We have with us today one of our speakers from the Companion Diagnostics: Technology and Reimbursement Track, Dr. Richard White, director of Global Brand Strategy at Genomic Health. Dr White, thank you for joining us.

Richard White:
You're welcome.

Amid Zand:
We know that the diagnostic test to stratify patients and guide therapy are becoming a reality in the healthcare setting. The technology is maturing and the companion diagnostics market is getting tighter. So based on that I have two questions for you. Number one is, is there any room left for improvement in the companion diagnostics offering? And if there is a room for improvement, can you predict the future for us? What are the technologies and companion diagnostics moving to in general?

Richard White:
Yeah, I mean there is absolutely a lot of room for improvement in companion diagnostics. I think we have seen over the years just an improvement of first of all what is the definition of a companion diagnostic, defining that for people, defining that both for the government, regulators, and also people in the development of the companion diagnostic. I think that area itself is still evolving and still improving. So even before we get to the technology, I think how we define companion diagnostic, how we regulate them globally, how we bring them to market, and how we actually use them, there's many areas for improvement here.

Over the last 10 years or so we've seen through the FDA probably a total cumulative of 20, about 23 what you would call companion diagnostics. Some of those are classically defined as being in drug labels, other are not "in the drug label". I think there is room for improvement. First of all in terms of regulatory, I think if you look around the world you'll see that different regulatory bodies have different regulatory criteria for companion diagnostics. You know in Europe they have a CE-mark label for their IVD, in Japan it's MHLW, in the United States is obviously the FDA, both the 501K or PMA.

So from my current view of how I think about things globally, I think there's a lot of "lack of alignment" around how we actually regulate companion diagnostics. I think from what I just said previously, what we consider a true companion diagnostics, the classic way is one that is actually included into a drug label, and then that is used by the physician for he or she to inform make a better treatment decision.

I think, again, as you mentioned previously, if you look at over the last 10 years in the cumulative 20 or so tests that are "companion diagnostics" all of those are not in drug label, but they're being used to actually guide therapy. By strict definition I think we'd probably be left in 20.

I think we have a lot of headroom, I think we've been moving in a positive direction, but I absolutely believe there is a lot of improvement in the companion diagnostics.

Then you say, we talk of heightening, I think, yeah, there's more attention, I think there's more players in the field of companion diagnostics, I think from the pure IVD perspective I think we [inaudible 00:03:04] the pressure for increased revenue in the diagnostic space. I think more and more companies are seeing companion diagnostics as an opportunity in terms of increasing business, so I think that has increased the level of competition, so the market is getting tighter. But as previously I think exactly what companion diagnostic is and how it's going to be regulated is a huge question for us in the future.

Amid Zand:
For the next question Dr. White we are very much looking forward to the Next Generation Diagnostics Summit, and this year we're expecting an outstanding event. Can you tell me what are you main expectations for this upcoming meeting and your participation?

Richard White:
Yeah I think for me, one of the hot topics, a couple of hot topics. Number one is the role of next generation sequencing. I mean just implicit in the title makes people of the summit, males people think, right? So how are we going to incorporate next generation sequencing in companion diagnostics? What does that really look like?

I mean there's been a lot of activity in next generation sequencing with a whole new genome thing now coming to fruition, but there's still the issue of how we're going to use a very sophisticated technology, even though it's become more portable, to develop companion diagnostics. Then how are we going to distribute that technology in a way where we can have access to it readily. One of the big questions for me is, how do we get access to that information in a very timely way?

You have multiple models now and [inaudible 00:04:30] most of what you see, and you have a centralized model where the testing is done in a big laboratory or wanted by the big lab companies. Then that information is then over a couple of days and even weeks that information is then sent to the healthcare provider for he or she to help make a decision for their patients.

I think that is the current model. But for me I think we need to think even more and the increased number of people with the Affordable Care Act having access to healthcare how we can actually use that information in a very distributive model, where we can get that information closer and closer to the source of the patient and therefore lower the cycle time upon which the physician can get that information and for it to be useful for making an informed patient decision.

Then the other issue is big data, how are we going to make readily available all the information that's coming to us from the next generation of diagnostics? Some of that will be sequencing. You have other folks who are actually using protein based diagnostics as well. But the issue comes now to how are we able to then use that data and filter it? How we're able to mine it? How are we able to then make it into a clinically actionable information? That's the key. How are we going to use that information partitioning and then make it clinically actionable.

[Inaudible 00:05:41] we have a lot of data, but data is not always information. You've got to go from big data to big information I would say, and then find the kind of platform upon which that information in my opinion can be widely distributed and can also help with the pressure we're going to be under, both in the laboratory and the physician office to deal with this increased amount of patients that physicians are going to see.

We cannot separate the two. We have to think more holistically about not being separated from this issue of what's going on in healthcare. I think the more we can align those two areas and pull those together, that is the area of technology companion diagnostics and the area of how we're going to deliver health care for the future, to me those are inseparable topics, and I would love to hear all my colleagues began to discuss that and become more of a holistic type of part of the overall answer to the problems we're going to face in the upcoming years in healthcare in the United States and also globally.

Amid Zand:
That was Dr. Richard White, director of Global Brand Strategy at Genomic Health. He will be speaking at the Technology and Reimbursement Track at the upcoming Sixth Annual Next Generation DX Summit, also known as Next Generation Diagnostics Summit, taking place on August 19th to 21st in Washington DC.

If you would like to hear him in person go to for registration information and enter the key code podcast. I am Amid Zand, associate conference producer. Thank you for listening.

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