NEW YORK (GenomeWeb) – Throughout history, diagnostics has been a footnote in healthcare, or at most, an asterisk to expensive drugs when people talk about making care more personalized and cost effective.
The diagnostics industry has been trying to raise the profile of its tools and tests for years, and demonstrate to payors and decision-makers that they require increasingly specialized expertise, complex technologies and algorithms, and are instrumental to how patients are diagnosed and treated. Despite this, industry players continue to bemoan the fact that payments for diagnostics haven't increased in step with their value.
The way to change the conversation is through academics, believes Mara Aspinall, a diagnostic industry veteran who led Genzyme Genetics for a dozen years and headed up Roche subsidiary Ventana Medical Systems. She spearheaded the launch of the International School of Biomedical Diagnostics at Arizona State University two years ago in partnership with Dublin City University and other industry partners.
The one-year, online master's degree offers midcareer professionals a chance to develop specialized expertise in the technology, science, business, and application of diagnostics. And enrollment has been doubling since the launch of the school in 2015.
"As much as we've made tremendous advances in the therapeutics realm, we can't move forward and use all of them cost effectively, unless we have that accurate diagnosis," she said in a recent interview. "What we hope to achieve with this school, and many others in the future, is to have diagnostics be recognized as a discipline in and of itself, yet integral to all the other medical and scientific disciplines."
Below is an edited transcript of the interview.
The diagnostic industry employs 3.5 million worldwide, and diagnostics are responsible for 70 percent of all clinical decision-making. But diagnostics account for only 2 percent of healthcare spending. The diagnostics and lab industry has been wanting to change this dynamic for some time and convince lawmakers and payors to pay for the value that tests add to patient care. Why has this been so challenging to achieve for the industry?
The statistic about 70 percent versus 2 percent has been around for a while, and the conversation needs to expand from that to encompass the reality of what we deal with on a day-to-day basis. The first additional statistic I would give you is that those diagnostics that we're talking about accounts for 80 percent of what's in an electronic health record. So, if you go even further, not just the decision-making, diagnostics are core to the medical record. This is obvious, but in many instances the diagnosticians in a hospital are not part of the discussion around how to frame and create an EHR in a hospital.
The broader issue is that diagnostics has a challenging history. For a long time, for decades, it was thought of as the simple analysis that was done behind the scenes. In the early years, diagnosis was done using the doctors' five senses. The diagnosis was the simple part, the treatment was the complexity. What we have learned, through the improvement of diagnostic technologies and the subtleties of disease, is that the diagnosis itself is the first step toward treatment or cure.
We have to change the perception of the industry. For the longest time, the diagnostics themselves were also relatively inexpensive compared to any treatment. There were these small dollar amounts. While that has not changed in proportion to therapeutics, what has changed is the perception that these are no longer products that are just a few dollars each. And that has been tough.
In envisioning these challenges, at what point did you think you needed a school for diagnostics?
We have been talking about [these challenges] for a long time. I went back to my conversations, and they haven't changed in over 10 years. The fundamentals that we talked about 10 years ago, are still the challenges today. What I realized is that when you look at the creation of other fields … when it becomes an academic discipline is when it gains credibility. With academic research it gains the additional gravitas that this is something that didn't just happen one by one, by one doctor or one hospital. Rather, this is something that is a science in and of itself, something that has power beyond the individual [example] on a day-to-day basis. That’s what I believe diagnostics was missing.
In addition, we realized that we needed a school because everyone in the industry was learning one day at a time. The industry was made up of people who had come from pharma, who had come from diagnostic technologies, or were pathologists. We needed a generation of business executives that understood diagnostics from the core. That requires the ability to teach it and to focus on the fundamentals of the science, the technology, the financials, as well as the application.
So, is that what the industry is missing — more business executives who don't start off in other parts of the life sciences space but as diagnostics professionals?
No, students at the school start off in all aspects of the healthcare industry. Approximately 70 percent of our students are midcareer executives. They are in a pharmaceutical company, a biotech, a diagnostic firm, or a hospital. We have several pharmacists. They are coming to recognize that they want and need more depth of understanding of diagnostics in order to advance their careers.
They come to us to get that additional depth in academic science but also in practical experience. One of the key pieces of our program is that all of our students are required to do an applied project, so they get experience outside their individual field to learn about diagnostics in practice.
What kind of projects are students pursuing to meet that criteria?
It's a broad range. The business-oriented projects are focused on market research in the US and around the world, [for example] on adoption curves — how diagnostics have been and can be adopted in various markets. Some of these projects are focused on market sizing and what the opportunities are for companies in a particular aspect of the diagnostics world.
What's most important to highlight in terms of the applied projects is that the companies are requesting them. So, it is for the most part, biopharma — both the bio side and the pharma side. These are companies that are introducing new products, expanding their markets, and are looking to get a better understanding, with the help of our students, of how their product or service will be adopted.
The second area is in bench research. A number of our students have the ability to work in a lab and work on diagnostic-specific systems. Our third area is one of great focus in the school: bioinformatics. Our students work on curating and quality-controlling [data], and interact with a company's team on a particular algorithm that will be used to improve a diagnostic.
Bioinformatics is an area with workforce shortages. I've heard organizations talk about their need for bioinformatics expertise in comparison to the expertise they currently have. Are there other areas in diagnostics with workforce shortages that the school might be able to address?
Arizona State University has a strong biomedical informatics department and a strong program in [math and statistics]. George Runger, who heads up the International School of Biomedical Diagnostics today, is also the chair of the biomedical informatics department. That's a key piece of it. [For] students who are midcareer, learning more about statistics, bioinformatics, and how it impacts diagnostics is one of the reasons that they are taking this master's degree. But for students directly out of undergraduate work, we find they're in two areas. Premed students appreciate the ability to learn more about all aspects of the diagnostics industry. The other area is in informatics, and students who might have a master's in math and statistics are looking to deepen their understanding of the field by [learning] how [these disciplines] work in diagnostics.
The school has been enrolling students since 2015. Is student enrollment growing?
We started with 24 students. We moved to 48 the next year and this year we're at 71 students in the master's program. We expect 100 students next year and at least 250 in years beyond that.
With a Master of Science in biomedical diagnostics, what types of jobs are students getting? Does the program have a job placement service, particularly since it sounds like they could be working with a company doing research for their applied projects?
Most of the students, remember, are already happily employed and doing very well. This is more about getting experience from what is happening in the world at large. ASU has a large placement office for students who are graduating college and looking for jobs. We have had success where students who are graduating college, have had internships and have been placed in jobs.
From the companies' perspective, for some of them it's about hiring, but mostly they want access to the best and the brightest in the field. For students doing research for their applied projects for companies that are not competitive with their [employer], it gives them a chance to get experience in a different field.
In recent years, as genetics has become more integral in areas of pharmacogenomics and cancer, medical and pharmacy schools have been revamping their genetics education programs. The University of Miami, for example, has a master's certification program on genomic medicine for first-year medical students. Is there a similar need for other schools to revamp their approach to diagnostics education? How are people getting this education if it's not on the job?
For the most part, it is on the job. That has been an effective way to do it for decades. Physicians are practicing diagnostics successfully on a day-to-day basis. The second way has been through individual companies when they release a new product, for them to do the education of the marketplace. I don't see either one of those changing. They are an important part of our landscape.
My vision here is that the baseline education should start much earlier. Ultimately, we will have an undergraduate major in diagnostics, we will have medical schools better teaching diagnostics, and have pharmacy and nursing schools teaching diagnostics in and of itself. That will improve the foundation of knowledge about the industry, so that when an individual company talks to a healthcare professional, they've got that foundation of the importance of the science, the technology, and the application of diagnostics.
My vision and the vision of all of us associated with the school is that diagnostics is a core to treating patients effectively. I believe a patient has nothing without an accurate and timely diagnosis. As much as we've made tremendous advances in the therapeutics realm, we can't move forward and use all of them cost effectively, unless we have that accurate diagnosis.
That is the core to genomics, and it is the core to companion diagnostics. As opposed to diagnostics being the asterisk on someone else's science — pharmaceutical science, biology, chemistry — what we hope to achieve with this school, and many others in the future, is to have diagnostics be recognized as a discipline in and of itself, yet integral to all the other medical and scientific disciplines. Without having professors and students who are focused on that, we cannot achieve it.
At what point do you think you can start an undergraduate degree specifically in diagnostics?
First, we will start a PhD program in the next few years for students who want to work with professors to create research in the field. We've already begun to do that. After that, we'll be working with medical schools, and we're already in discussions with them, to add diagnostics to their curriculum. We can provide the core material to do that. The third piece will be adding an undergraduate minor, and ultimately a major, as the field develops.