Reflections on the past 15 years in the industry.
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In vitro diagnostics is, by many accounts, an underrated, undervalued industry. While pharmaceutical and therapeutic medical-device innovations tend to garner most of the mainstream media’s attention, the fact remains that 60 to 70% of medical decisions are influenced by some type of diagnostic testing, yet diagnostics accounts for only a tiny fraction of overall healthcare spending.
Some of the major developments within this very important industry during the past 15 years include increased automation, enhanced workflow, better product quality, and the discovery and commercialization of PCR. At the same time, market fragmentation and clinical utility of lab tests continue to pose challenges.
For in insider’s view of IVD’s past and future, IVD Technology’s editor-in-chief Richard Park spoke with Steven R. Binder, Tiffany P. Olson, and Thomas M. Tsakeris.
IVD Technology: How has the IVD industry changed during the past 15 years?
Tiffany Olson: One of the most notable changes has been in automation. Who would have thought robotics, sample prep, and sample in/result out would be standard instrumentation in most laboratories? It’s commonplace to see chemistry, immunoassay, and hematology instrument lines in the laboratory. Automation has increased efficiencies, reduced human error, and helped to revolutionize laboratory medicine. Given the aging population and scarce laboratory resources, it will continue to play an important role in years to come.
Steven Binder: I agree. I think workflow is the key word. The instruments were not really developed with the customers in mind 15 years ago to the extent that they are now, and understanding what makes work easier for the customer has been driving the design of instruments.
Total lab automation and modular automation, which were really not seen outside of Japan in the 90s, have made their way into the United States and many countries around the world because of the need for more automation and easier workflows.
Automation allows laboratories to satisfy physicians with guaranteed delivery times, with contracts between labs and hospitals. “If you get the sample to me by time X, I get the results back to you by time Y.”
Thomas Tsakeris: In the regulatory sense, the more things that have changed, the more they’ve stayed the same. I mean, we still have, from a regulatory perspective, the same fundamental rules and regulations and laws. While there have been some important changes in the last 15 years—the ASR regulation comes to mind, as well as FDA’s In Vitro Diagnostic Multivariate Index Assays initiative, which has given pause to many in the industry that are affected by it.
But in general, I think the biggest change in the last 15 years, as far as regulation goes, is probably happening right now. The whole concept of how FDA approaches its regulatory processes, such as the 510(k) process in particular, is undergoing some fundamental rethinking.
And I think that ultimately will have a big impact on how IVDs are regulated. I’m referring primarily to the whole concept of substantial equivalence. That clearly has changed over the last 15 years.
So, Tom, with regard to all of the various changes and improvements from a technical and technological standpoint in the IVD industry during the past 15 years that Tiffany and Steve talked about in terms of automation and workflow, do you feel that the regulations have not kept up?
Thomas Tsakeris: I think in some respects it has kept up pretty well. Roughly 99% of all new IVDs that reach the marketplace are through the 510(k) review process.
So that process is still working pretty well, although you can always talk about how things need improvement. One of the things that’s evolving, even as we speak, is the idea that if you have a new technology platform, or perhaps you’ve discovered a new biomarker, it may raise new issues of safety and effectiveness that can’t be easily compared to technology platforms or markers that were approved 15 years ago.
When you look at the questions that the FDA is asking as part of their review of premarket submissions, just simply telling the agency that you’re equivalent from an intended-use standpoint is one thing. But the agency now seems to be asking more questions about, for instance, if this product or this test becomes approved, how does one reconcile the new test if it doesn’t agree with the predicate test?
And that is a very remarkable question. It’s very problematic. I see more and more of that type of questioning as part of the underlying review of clinical utility. And that’s the thing that I think is important.
Besides automation and workflow, what were some of the other big achievements in the IVD industry during the past 15 years?
Steven Binder: The lab-tech shortage, which was discussed extensively in your roundtable five years ago, continues to be a major concern today. Given that laboratories see volume increases of 10 to 15% every year, this is to me the most important thing that the diagnostic industry has addressed, because without this automation, without this improvement in workflow, physicians would become very frustrated, especially in this country, where the volumes are increasing the most.
And the fact that the industry has been able to come up with these automation solutions has allowed the use of lab tests to continue to expand, despite the limited number of people available to do the work.
If you calculate efficiency by dividing the number of tests that a lab did in a year by the number of people who were running tests, the increase in that number would be extremely high.
Thomas Tsakeris: I certainly sense that the quality of testing has been measurably improved. Yet at the same time, I believe that the number of recalls is simply too high. And so another reason I think FDA is engaged in all sorts of programs internally, such as looking at how users are using products, doing risk analyses, performing extensive risk analyses, trying to come to the root of why there are problems, is because more products are being approved or cleared for marketing day in and day out. That said, there are still lots of apparent problems in production, and I think that is something that is still worrisome at FDA.
Tiffany Olson: The discovery and commercialization of PCR has perhaps provided the largest value over the last 15 years in laboratory medicine. PRC has helped in identifying infectious diseases, providing early HIV detection, and serving as an enabling technology in the decoding of the human genome. PCR has advanced medicine and patient care. Now with the wealth of data that we have from the human genome, the future will be in trying to turn it into meaningful health information. Over the last several years the ability to provide genetic testing has propelled personalized medicine to the front pages of newspapers and magazines. The general public is aware of molecular medicine, as can be seen in the direct-to-consumer genetic organizations. Whether you agree with the concept or not, it just shows that laboratory medicine has made it out of the basement.
Even in pop culture, laboratory medicine has become an exciting profession, with television programs such as CSI that are helping to generate interest for the younger generation. PCR and molecular testing has gone Hollywood and with it a public yearning for more innovation.
Thomas Tsakeris: What strikes me is that there is so much information available on the Web now. And primarily on the Web, I have noticed that everybody who has some sort of condition and is willing to discuss their disease or condition with others, friends or family members, can get in response a tremendous amount of feedback along the lines of, “Have you been tested for this? Have you been tested for that?”
I think the public is becoming a lot more sophisticated about technology and about medicine. And it’s starting to show up in family conversations, a lot more so than maybe 15, 20 years ago.
Tiffany Olson: Agreed.
What were the biggest hurdles and challenges that IVD manufacturers had to overcome during the past 15 years?
Tom Tsakeris: When you talk about the IVD industry, the first thing you have to think about is: Who comprises the industry?
Fifteen years ago, or even four, the IVD industry was, in my mind, the traditional company like an Abbott or a Bio-Rad or a Becton Dickinson—a traditional company that makes and produces test kits and instrument systems and reagents.
With the advent now of laboratories and laboratory-developed tests and FDA’s interest in developing policy on regulating certain types of laboratory-developed tests, the number of producers has increased; the competition has certainly increased.
The players in the IVD industry are colleagues as well as competitors. They’re consumers as well as competitors.
So the dynamics within the IVD industry have changed considerably from my perspective in the last 15 years, simply because of the fact that the labs, which have been traditional consumers of IVD tests, are now also producers—and they’re competitors to the IVD companies.
Tiffany Olson: The industry still struggles with explaining the value that diagnostics can bring to the healthcare system. As we know, 80% of all patient information includes some type of diagnostic testing, yet it only accounts for 3% of the overall healthcare expenses. Laboratory testing is one of the best buys in healthcare.
With healthcare reform, the value that diagnostics can bring to the patient and in helping to reduce waste needs to continue to be told.
Another challenge will be the rapid change of infectious diseases such as HIV, hospital acquired infections, SARS, and avian flu. There will be challenges for the industry in speed to commercialize testing.
New deadly diseases will continue to occur faster than before, industry and regulatory will be forced to work together to solve these problems.
Steven Binder: I fully agree with Tom regarding fragmentation of the market. It’s a major challenge going forward. Regarding clinical utility of the lab tests, this continues to be a problem. We clearly don’t get our share of the healthcare dollar. The doctors have shifted their focus from disease diagnosis to disease management.
When you see a television program like House, it’s a little misleading, because it implies doctors spend all their time trying to figure out what diseases they’re dealing with, when, in fact, most doctors have little time for that. That’s one of the reasons they don’t value diagnostics, and that’s really a big challenge.
Although DNA testing has been great for infectious diseases, it’s been great in other areas, too, like for genetic diseases and human leukocyte antigen. It hasn’t been great yet for cancer, diabetes, and certain other diseases.
Even with infectious diseases, we’ve used DNA to replace serology and microbiology methods. In general, we haven’t added that much new content to the menu for DNA. There are some things that are new, like HIV genotyping, that we didn’t have 15 years ago, but mostly we’ve moved from one technology to the other.
But the problem of identifying new biomarkers is where we really have a pretty sorry record. You may have all seen the chart that Dr. Leigh Anderson of the Plasma Proteome Institute shows about how an average of one to two biomarkers are introduced every year, maximum. Some years, it’s zero. We have a huge amount of investment, especially on the pharma side, in new biomarkers. That’s not coming out the bottom of the clinical diagnostic pipeline. And we really haven’t offered a lot to address many of the chronic diseases.
So what we really need are some truly new tools for addressing medical questions that are pretty much unanswered today.
Tiffany, I wanted to follow up on a point that you made in the previous question about the IVD industry’s biggest achievements. You specifically identified PCR, molecular diagnostics, and decoding of the human genome. Now, without a doubt, molecular diagnostics is one of, if not the fastest-growing segment of the IVD industry during the past 15 years, and it’s had an incredible impact. But if you recall, back when the human genome was first decoded, everybody was predicting that it would completely revolutionize IVDs and take over the industry, but my understanding is that it hasn’t quite reached the level that people were expecting and had hoped for. Please comment on that.
Tiffany Olson: I would agree that the industry is not as far along as would be expected. When some of the articles on the power of companion diagnostics first started hitting the mainstream media such as Forbes and The Wall Street Journal, the expectation was that a revolution in medicine would take place. Today there are still just a few limited examples where a diagnostic and pharmaceutical are proactively paired together. This is partly due to the lack of collaboration between the pharmaceutical and diagnostic industries. As the cost of healthcare is coming under greater scrutiny, the two industries are starting to work more closely and are understanding the value of companion products.
And Steve, you talked about work shortages in the labs and called how the IVD industry has addressed that by implementing various automation solutions a “success story.” The population is, of course, growing and growing, and the Baby Boomer population is aging. With these demographic factors in mind, are work shortages something that IVD manufacturers will need to continue to address in the next 5, 10, 15 years?
Steven Binder: Absolutely. I don’t think anybody expects the amount of testing to go down any time soon. No convincing solution has been proposed concerning how we get more people working in the laboratory. So unless hospitals are willing to invest in building larger laboratories, the burden will be on diagnostic manufacturers to get things done more efficiently.
One solution is the relocation of lab tests. Hospitals in some cases choose to offer only emergency testing, and they send out everything else. So you get centralization. Testing may be sent out to a regional lab. It may be sent out to a large reference lab. But that’s work taken away from the hospital. When it goes to a larger center, it can be more easily automated with higher throughput, lower cost per test, et cetera.
The other solution, of course, is to return testing from the hospitals to the doctor’s office, which we haven’t talked about yet, because it’s a trend that’s still in the future. But one could imagine the burden on hospitals also decreasing if more tests were moved closer to the patient.
How do you view the current status of the IVD industry? Would you have believed it if someone told you 15 years ago that the IVD industry would be where it is today? Do you think the IVD industry should be further along than where it is today?
Tiffany Olson: The industry is at an inflection point, and companion diagnostics will cause different business models to emerge. With the growth of molecular testing estimated at between seventeen and nineteen percent, innovative diagnostics will continue to be developed in this segment.
Oncology in particular lends itself to molecular testing and more companion products. In a recent decision from ODAC, ChemGenex was advised to have a demonstrated validated diagnostic before regulatory submission of its oncology therapeutic.
There is tremendous pressure to decrease overall cost and waste in the healthcare system, being able to aid physicians in answering what is the right drug and the right dose at the right time, will greatly improve patient care.
Other surprises that no one would have predicted include the potential of the $1000 genome. Also, new players never anticipated to be in diagnostics have emerged such as Siemens and CVS/Caremark, and we can expect to see others. Regarding your question, “Are we where we should be today?” the point-of-care testing segment comes to mind.
When point-of-care testing was first being proposed to hospitals, there was a belief that laboratorians would wear a “tool belt” with all types of testing that would be done at the bedside. There has been a slower adoption rate than what the industry predicted.
Steven Binder: Genomics has been a major development. The imminent $1000 genome has the potential to completely change the industry. No one would have predicted that. The other thing, of course, is the Internet. It’s very hard to remember how primitive we were 15 years ago on the Internet.
We talked earlier about the idea that people look up their diseases online. Of course, you can now check your lab results on the Internet, which was inconceivable 15 years ago. Also, you can order lab tests on the Internet, which is a problem from my point of view. Those are the things I wouldn’t have predicted.
Two surprises: I would say limited expansion of point of care again, and then the absence of good clinical-utility studies to justify diagnostics to me is very disappointing. Hemoglobin A1c is one of the few analyses that was thoroughly evaluated in terms of its clinical utility and is now used as a textbook example of how such things should be done. There aren’t too many other examples like that.
Thomas Tsakeris: One is reminded that the current status of any industry is highly dependent upon the national economy. And right now, there is stress in the economy. We hear about it all the time. We feel it, too.
And I think the IVD industry, at least in the last couple of years, has experienced the same types of fallout from the distressed economy— namely the fact that there have been layoffs, there have been mergers, and there have been complications that have arisen as a result of the fact that, while there is still a demand new IVD products, you also have situations, particularly among the smaller innovative companies, in which all the new biomarkers and companion diagnostics and molecular-genetic tests are being developed.
What we’re finding is that many of these companies have great ideas. Many of the markers and tests that they’re developing have considerable promise. But the fact is that these companies get to a certain point where they simply run out of resources to pursue an end game.
Sometimes they don’t even get into the game. It’s been my experience, for example, that, as far as my consulting is concerned, many of these companies develop protocols for proposed-test clinical testing and the demonstration of clinical utility. They get the blessing of the agency to go ahead, yet the studies never get done.
And that is unfortunate, because these companies simply run out of resources, and they wait until they’re either bought out or someone else is willing to pick up the tab. And that’s disappointing.
As far as looking back 15 years, I think the molecular diagnostics area has been something that was anticipated once the human genome was mapped. That project certainly gave rise to a lot of the molecular diagnostics that we’re seeing today.
So I think there was an anticipation of growth. And there certainly has been growth. But my biggest feeling of disappointment is for the point-of-care industry. Here’s an area where we would anticipate that the application of new technology to a very favorable environment would be to develop a new point-of-care test. But that hasn’t happened. I’m not sure what the reason is. Is it because of regulation? Is it because doctors aren’t interested in doing point-of-care testing? It’s hard to say why we haven’t seen more of it. But it is an area in which I would like to see more progress.
What do you think will be the biggest achievements in the IVD industry during the next 15 years?
Steven Binder: I think that the multiplexing technologies that have been developed for both proteins and DNA offer a lot of opportunities. First of all, they offer numerous opportunities to reduce costs by combining reagents, calibrators, controls, ergonomic savings, et cetera. We’re already seeing products like this for autoimmunity and serology. We are also seeing it in other areas, like HLA testing and molecular diagnostics for respiratory viral panels. These approaches could be greatly accelerated by next-gen sequencing on the DNA side, as well as the further commercialization of protein arrays. So this achievement is something that I’m quite certain is going to happen, probably in more like five years than 15 years.
Over a 10- to 15-year period, another technology that may come into play is mass spectrometry, which is now being developed for large protein panels. It has already been developed for DNA panels by Sequenom. We already have mass spec for small molecules for newborn screening. The growth of mass spectrometry, although it may not be available to every hospital, will open all sorts of new frontiers.
There are challenges in multiplexing because of the need for algorithms, but these are solvable problems, in my opinion, well within the range of current technology, and I expect to see a lot of growth and a lot of new medicine coming out of this.
Thomas Tsakeris: I don’t know what will be the biggest future achievement for IVDs. I think we’ll all be surprised by whatever that achievement is. I have a wish list based in part on what I see as promising developments today that I think will be enhanced as time goes on and technology becomes more developed.
But one of the things that’s sort of exciting for me is in the area of digital pathology—such as the digital-slide concept, where one can rely on looking at a digitized image and then make judgments about the image and send the image around. Here again, the Internet plays a valuable role.
You can have teams of clinicians who are able to confer more easily. And so I think that is one specialized area where I hope and expect to see a lot of interesting developments.
Another area that I think has stalled over the years gets into the new-biomarker-discovery discussion.
We’ve already talked a little bit about the fact that there are scant new biomarkers that have been approved. Or, when you look at biomarkers that are used for screening or early detection of cancer and other serious diseases, despite the fact that we have all this new technology with molecular diagnostics and microarray technology and so forth, we have yet to see that magic bullet of a marker. We’re lacking the ability to identify definitively, let’s say, stage 1 pancreatic cancer—something where we can actually do something about the test result.
I am looking forward to the further evolution of diagnostic-biomarker discovery. I think, if FDA regulations can keep up, that we’re going to see a lot of growth in that area.
Tiffany Olson: I agree with both Steve's and Tom’s comments. In addition, we are going to see China become a huge player—estimated to be the second largest healthcare market—and their unique needs within the diagnostic industry will cause global manufacturers to design products differently.
What about the India market?
Tiffany Olson: Yes, that’s also another very large emerging market. India, China, Brazil, and Russia are all going to be large markets in the future.
In general, would you say that many of these so-called emerging markets outside of the traditional dominant markets, like North America and Europe and Japan, will play an even greater role in the IVD industry in the next 15 years?
Tiffany Olson: Manufactures will need to make sure that the needs of these countries and customers are taken into consideration in the design and commercialization of products. The clinical practice of medicine in different countries must be considered.
What will be the biggest hurdles and challenges that IVD manufacturers will have to overcome during the next 15 years in order to reach the various achievements that you’ve mentioned?
Thomas Tsakeris: I think the hurdles we’ll encounter in the next 15 years aren’t going to be fundamentally different than the hurdles of the last 15 years. I think it’s a question of scale and economics. And I think that, to continue to be innovative, what we’ve seen is that a lot of the new innovative tests are being developed by the small companies. That’s not to say that the large companies aren’t building their fair share. Clearly, they’ve got the resources, the R&D budgets to discover new diagnostics.
But the challenge is really going to be the availability of resources to continue to develop the R&D budgets that are going to be necessary to realize some of these new diagnostic tests, which we all hope will make healthcare better in the future.
So bottom line is, I think it all has to do with economics. I think the challenges of raising money to contribute to R&D to develop the tests is significant. And then, of course, there is always the regulatory burden. I would like to see FDA go back to the basics as they deliberate further on the evaluation of new tests.
Right now it’s as if the glass is half-empty almost in everything that comes up that’s new at the agency. I’d like to see that change.
Tiffany Olson: I agree with Tom on the need for regulatory changes and the ability to accelerate innovative products to market. If regulations become burdensome, they will stifle new testing and innovation.
From the standpoint of R&D efficiency, the challenge continues in providing new biomarkers that will have a clinical impact. As pharmaceutical and diagnostic industries work together, optimizing R&D outcomes will be essential to a company’s survival.
Steven Binder: First of all, I do believe FDA is going to change the rules in the near future, maybe even by the time this interview is published. And if that’s the case, that’s the biggest challenge, because any change in FDA’s way of looking at the universe will have huge repercussions on the diagnostic industry, on the startups, on the reference labs, on everybody.
Companion diagnostics are a big challenge, in the sense that they offer the biggest opportunity. Lots of people would like companion diagnostics to succeed, but there are economics issues associated with the long time to development. There is the regulatory issue, in that there isn’t really a lot of guidance yet.
And finally, there is the clinical utility issue. What I like about companion diagnostics is that, if we do find a way to launch kits and drugs at the same time, there’s built-in evidence of clinical utility behind that decision. What’s been killing a lot of these new markers and even a lot of the point-of-care devices that Tom was talking about has been the lack of congruence between when you launch it, when it gets regulatory approval, and when it gets reimbursed. So getting those three things lined up and working together would do a huge amount to propel new markers and new technologies, if we can figure out how that’s done.
Tiffany, you mentioned that during the next 15 years you expect that there will be new and different competitors in the IVD industry, with new business models. I’m wondering if you could elaborate on that point a bit and specify what sort of new and different competitors you mean, and what sort of new models they might possibly bring to the IVD industry.
Tiffany Olson: One of the trends that are occurring can be seen with the specialty providers and large retail pharmacy chains. They are offering diagnostic testing, therapeutics, and IT information that they claim can save their members costs. It is an interesting model that others might choose to enter, such as IBM, Walgreen’s, McKesson, or other large distributors.
Steve and Tom, you each mentioned the impact of the Internet. Could you please expand on how IVD manufacturers and the IVD industry will have to address the dissemination of information online and how it will affect business?
Steven Binder: The Walgreens example was a good one; it is direct-to-consumer selling. The Walgreens “kit” was just a collection kit, but it’s going to become more and more common—unless a major regulatory change occurs—for labs to sell directly to consumers and to bypass doctors.
Also, reference labs can also bypass the hospital lab by targeting doctors for a particular test—we see this now with Genomic Health. So the role of the salesperson is unclear right now, especially if we have targeted advertising via the Internet. That would be a really major change in the industry, from my point of view.
Although Walgreens may have failed to put this particular DTC test on its shelves, there is clearly potential for this to happen in the future. And it will be driven by the desire to utilize the Internet and other resources to go direct to the consumer and bypass other parties who may try to put restraints on the cost of healthcare.
Thomas Tsakeris: If there is one area where I think regulatory lag could develop into regulatory anxiety, it is in the area of offering tests over the Internet.
The rules and regulations that FDA and other regulators have developed didn’t really take into account the Internet at the time that they were enacted.
And I think that what makes this interesting is that there’s going to be this usual tension—and certainly the politicians are going to make a lot of hay out of this—between the consumer’s right to investigate their own health status, and the regulators, who are often trying to protect the public from themselves and are fearful of any sort of significant abuse that might occur in these direct-to-consumer enterprises. Any failures are going to be perceived as a lack of regulatory oversight.
And these kinds of things have a habit of having bad outcomes in that the oversight tends to get perhaps more extreme than maybe it needs to be. On the other hand, who’s to say? It depends on which side of the philosophy you happen to be on. Do consumers have the right to know? And should they be able to take responsibility into their own hands? Or do we need to have the government involved in many of our day-to-day activities?
I think it’s going to bring up some very interesting ethical issues.
What do you think will become of companion diagnostics and personalized medicine with regard to IVDs and the IVD industry during the next 15 years?
Tiffany Olson: This area is ripe for change over the next 15 years. The companion-diagnostic segment will be similar to the growth and adoption we’ve seen with molecular testing. Business models, partnerships, and acquisitions between pharmaceuticals and diagnostics will go beyond oncology to areas like Alzheimer’s and rheumatoid arthritis. In the future, testing will always be provided before therapy. Science and industry are just starting to make this a reality.
Steven Binder: There are a lot of IP issues to be resolved. For example, if you want to make a particular drug work with a particular test, that is somewhat straightforward. But if you want to take advantage of science that’s being developed in a number of places and being patented in a number of places, and combine that knowledge into a single test, there are many IP challenges.
This issue has already popped up for BRCA, which was mentioned before. It has popped up in rare genetic diseases. So finding solutions on the IP side to support personalized medicine becomes much more complicated, because even the one-drug, one-lab-test problem is not always easy to solve.
The other problem with personalized medicine on the legal side is standard-of-care issues. That’s another problem that has to be solved before personalized medicine can truly succeed.
Thomas Tsakeris: I certainly would like to see a better process at FDA, to make it easier for drug companies and diagnostic companies who may be partnering to be able to better synchronize the premarket approval process so that the drug and the diagnostic are approved at relatively the same time.
The nonregulatory challenge that I think will take some time to iron out is that of a small IVD company that is faced with partnering with a big pharma company. What I have seen is that not only are there wrinkles at FDA that need to be smoothed out to allow the companion diagnostic to proceed without undue delay, there is also going to be the wrinkle between the diagnostic company partnering with the big drug companies, which have different cultures and different ways that they approach problem-solving.
And so I’m hopeful that we’ll see more companion diagnostics, that there will be more development in that area. But the thing that is holding up progress is the fact that it’s hard for these companies to work together. They simply have different styles.
What should the IVD industry’s primary goals and objectives be during the next 15 years? And what do you think the IVD industry will look like 15 years from now?
Steven Binder: Consolidation is going to continue. We may reach the state where there are three or four major players and a moderate number of boutique players.
But what it really means from the industry’s point of view is that offering a full product line or a large product line may be important in order to survive. And it’ll become harder and harder, as Tom already mentioned, for companies that have one great idea and one product to break in on their own. It’s already pretty hard now.
Companies do need to think about whether their portfolio makes sense as a whole and how they’re going to compete in 10 years when laboratory results are combined with imaging results. To me, that is one of the biggest things that could change the industry.
I think the primary goal is to demonstrate clinical utility so that laboratory tests will be compensated appropriately, based on their value to human health.
Thomas Tsakeris: There will be a future for the IVD industry. We are all hopeful there will be breakthroughs in one aspect or the other of diagnostic testing. We touched on some of those, the wish list of some things that we might anticipate.
Tiffany Olson: In fifteen years, companion diagnostics will be commonplace, and the healthcare system will be much more efficient. Physicians will know what drug will deliver the best treatment for a particular patient. Point-of-care testing will continue to evolve, and IT solutions will solve current challenges—such as with EMR: electronic medical records. In the future, genetic testing will be considered standard, and individuals along with physicians will understand the impact of the diagnostic information. Diagnostics will be outcome-based, and the industry will need to continually provide innovations to improve patient health.
Steven R. Binder is director, Technology Development, for Clinical Diagnostics Group at Bio-Rad Laboratories (Hercules, CA). He can be reached at steve_binder@bio-rad.com.
Tiffany P. Olson is vice president, Diagnostics, at Eli Lilly & Co. She can be reached at olson_tiffany@lilly.com.
Thomas M. Tsakeris is president, Devices and Diagnostics Consulting Group (Rockville, MD). He can be reached at ddcgi@comcast.net.