COMMENTARY

Change Makers: Matt Sause on the Future of Diagnostics

John Whyte, MD; Matthew Sause

Disclosures

August 08, 2022

Dr Whyte speaks with Matthew Sause, President and CEO of Roche Diagnostics North America, about the future of diagnostics and its role in early detection, healthcare inequities, and everyday convenience.

This transcript has been edited for clarity.

John Whyte, MD: Welcome everyone, I'm Dr. John Whyte and you're watching Change Makers: The Future of Health, where we interview CEOs who are changing and reshaping how we think about health.

Have you done a lab test at home over the past year? It's amazing, isn't it? You do it on your time and when convenient for you, and you often get the results in a few minutes. Diagnostic tests keep getting closer to the patient.

I had the opportunity to visit with Matt Sause, president and CEO of Roche Diagnostics North America. Matt told me that we haven't focused enough on diagnostics. Most research dollars are spent on therapeutics, but think about it: We have to first diagnose a disease or condition before we can start that therapeutic journey. Diagnostics play a key role in our health, and they need investment. But how do we do that?

We also talked about how diagnostics are evolving. Will we have a time when we have tests that don't require any puncturing of the skin or drawing of blood? What's the evolving role of the physician when ordering the test? Do we really need it? And if so, when? It's a fascinating conversation about the future of diagnostics. Take a listen.

Matt, thanks for joining me today.

Matthew Sause: John, it's a real pleasure to have you here, and I'm really looking forward to this conversation.

Whyte: Let's start off with, how has COVID changed diagnostics? I could walk down the street and ask people about PCR and antigen testing, and many of them could tell me the difference. The majority of them would at least know what I'm talking about. That would not have happened 3 years ago. Has COVID fundamentally changed the diagnostic testing industry?

Sause: I think it absolutely has. What you just described is something that even my parents can describe the difference between PCR and antigen testing. And I think what that's done is that diagnosing COVID at the appropriate time has made a fundamental change in how we've managed this pandemic. There's been a lot of discussion about masks and vaccines, and I think testing has become a real cornerstone of the world's response to the COVID pandemic. So the average individual has significant more knowledge about testing than they would have had just a few years ago. Some of that information, I think, we'd like to continue to educate and drive the appropriate use of testing, but the general awareness has increased significantly. What that's done is allowed the general population to understand just how important testing is to the delivery of healthcare in the United States. According to the Centers for Disease Control and Prevention (CDC), 70% of healthcare decisions are based off of diagnostic testing, but only 5% of our spend on healthcare in the US is on diagnostics. I think there's a real opportunity for diagnostics to transform healthcare and move it to an earlier state of detection.

Whyte: But why is it undervalued? Is it because traditionally it hasn't been as glitzy in a way, or the news doesn't cover it as much, compared with when we have a new drug, it's often covered? When we have a new diagnostic, it may not get as much press. Is that part of the challenge in terms of the value that consumers see in diagnostic testing? Because you point out that you can't even start talking about treatments until you diagnose a disease or condition.

Sause: It's hard to say how we ended up in that kind of dynamic where people didn't perhaps value [diagnostic testing] appropriately, but I'd say that certainly what COVID has done is pushed it to the forefront and helped it establish its value. I mean, how many people now will take a self-test before they have a large party or before they go on a trip? How many people know when they go to the hospital to ask to get a PCR test? It's really fundamentally changed, and I think it's a moment for us as an industry to reinforce how critical it is to address the overspend on acute and chronic healthcare in the US and move it more to preventive care, which is also only 4% of the US healthcare spend. I think there's a real opportunity for us to shape how healthcare is delivered, and I'm excited to be in diagnostics at this particular moment in time.

Whyte: So you think we'll change more to a wellness approach? Because we've been talking about that for many years. We need to focus on prevention. We need to focus on screening. Will that be one of the lessons from COVID in terms of the diagnostics industry, that there'll be a shift more toward wellness?

Sause: I hope it is. Certainly what people understand is the power of diagnostics to change behavior, the power of diagnostics to make decisions. I think also as a function of COVID, we've invested significantly into our infrastructure for testing in the US. We've also invested significantly through programs like RADx through the National Institutes of Health (NIH) in enabling technologies, digital [healthcare], telemedicine, and new testing modalities to drive testing closer to patients. And I think that it's a moment to leverage that in terms of how healthcare is delivered and also how we're able to change wellness in the United States.

Whyte: You've talked about that need to bring diagnostics closer to the patient, and many people as you referenced, have been doing self-testing. Is that what we mean by "closer to the patient"? Or is it more about point-of-care in physician offices? How are we going to bring it closer to the patient on things other than COVID?

Sause: That's a broad question. I think how healthcare moves close to the patient really depends on the testing question. Certain tests definitely will still take place in a doctor's office close to the point of when the patient or individual is best suited to receive care. Other tests with a psychosocial element, or that are appropriate for lifestyle management — perhaps those are best suited for testing in the home. I think it's really going to depend on what indication we're speaking about in terms of which should move to what different setting.

An example is cervical cancer. We know that over 10 million Americans missed a cancer screening during the pandemic. As a result, we're not seeing less cancer; we're seeing more late-stage cancer. And that's an extremely unfortunate outcome. Now, certain things like cervical cancer screening, if there's an opportunity for that to be done in the home and mailed to a physician's office; there's an opportunity there to address a critical need in terms of how care is delivered and also allow it to fit within the changing way that people operate given the pandemic. People are less likely to be going into their doctor's office. If we meet them with a screening test where they are, does that then improve detection and will that change to better outcomes? That's the hope.

Whyte: We talk about patient-centricity, one aspect of which is convenience as well as adherence. Why wouldn't a patient want to do a test at home if they could vs traditionally have to drive somewhere or take public transportation for a quick test, and then do it all over? Many people will say that patients' expectations are fundamentally changed and they're not going to go back to the way it was — and that includes diagnostic testing.

Sause: Absolutely. If you look at things like utilization of telemedicine, it's dipped from where it was at the height of the pandemic, but it's significantly higher than what it was before the pandemic. If you're able to couple those telemedicine visits with objective diagnostic information that could be gathered and obtained at home, then you have an opportunity to improve care and improve access. Because I think one of the things that's also become apparent due to the pandemic is the number of individuals leaving the healthcare practice: nurses, physicians, laboratory staff. Staffing in hospitals and healthcare institutions has been a challenge for the industry. Diagnostics and also the use of modalities like telemedicine can hopefully address that. I think there's a tremendous opportunity there.

Whyte: You have a quote on your website that I want to read to you. You say, "The goal is to transform healthcare by delivering novel diagnostics to help improve patients' lives." What does that mean on a practical basis for viewers?

Sause: There's a lot of medical conditions that have high unmet burden, where the introduction of novel biomarkers and testing modalities can change how the outcome and how patients are managed. An example is preeclampsia. At 20 weeks of gestation, with hypertension and proteinuria, it's a condition that can have a significant impact on the life of the mother and the baby. So we have developed a blood-based task that received breakthrough designation from the US Food and Drug Administration (FDA) that could be used together with other information to rule out preeclampsia. That's a disease with significant burden here in the United States, and also one that disproportionately impacts different parts of our society. People of color are three to four times more likely to have a negative outcome for preeclampsia than other populations. There's other diseases like this, such as Alzheimer's disease, where people of color have 1.5 to two times the risk of developing Alzheimer's during their life and the availability of new diagnostic biomarkers to definitively diagnose those conditions is critical.

Whyte: But how do we know we have the right surrogate measure,? The right biomarker that's going to correlate? That's been an area of controversy at times. How do we sort that out?

Sause: The key there is doing the right investigational studies, and doing those investigational studies in the patient populations that are represented by what we just described, which is the changing demographics of those illnesses. So with our Alzheimer's trial, we have a cerebrospinal fluid (CSF) biomarker for amyloid beta 42/Ptal 181, which are two biomarkers that are well associated with Alzheimer's disease. And we correlate that with the gold standard, which is PET scan. So we take what's considered a gold standard and compare our performance with that. At the end, what we're very hopeful is that we'll have a test that can be much more broadly administered and create access to those populations that have higher disease burden.

I was reading the recent Nature Reviews Neurology, where it talks about that it's not just about the ability of biomarkers; it's about the availability of scheduling a doctor's visit. The majority of diagnosis of Alzheimer's today is done through a cognitive assessment. Cognitive assessments in certain communities are very difficult to schedule. I think with the availability of more definitive biomarkers, you can diagnose disease earlier, and by diagnosing it earlier, get that patient into management. That management will lead hopefully to better outcomes. So I really feel that with innovation, like in preeclampsia, in Alzheimer's, we can address some of the inequities in healthcare and bring innovation forward that will change how a lot of these challenging diseases are managed.

Whyte: What about cost? Cost is always an issue as we address equity. Many people are uninsured, and sometimes insurance isn't covering, as you know, especially newer tests. How do we address the issue of cost when we're trying to eliminate inequities?

Sause: That's a great question. By diagnosing disease earlier, you are removing a lot of cost from the system. If you look at late-stage diagnosis downstream — when you look at late-stage diagnosis of cancer, the cost of metastatic disease management vs detecting disease earlier, when often it can be cured, is dramatically different.

Whyte: But insurance doesn't think like that. Isn't that part of the challenge that we don't address how we should be investing? Why aren't we celebrating innovation in terms of diagnostics? All that you've just pointed out in terms of the improvements that we made — consumers aren't hearing about it, physicians aren't hearing enough about it. Why don't we have that celebration of the innovation that we've had during COVID that is continuing to persist?

Sause: That's a really great question. All I can say is that we're investing significantly in having the team that can build that access story that will allow us to have the conversation with payers to drive coverage. What I've taken a point of is recruiting a lot of the folks that are very good at developing this kind of evidence and working with payers from our pharmaceutical business and bringing them over to diagnostics, because the type of engagement that we're going to have with payers is going to be very similar in the future. And we want to make sure we have that same level of expertise to tell that story: You have this tremendous opportunity to improve quality of life, remove downstream cost, and move from this more acute and chronic disease management into a more proactive, like we were saying, wellness approach. It's really exciting, but it is not obviously without challenges, like you said, the general population still has an opportunity to become more aware of this.

Whyte: Innovation requires resources, you pointed that out. One aspect of resources is people, and we've talked a lot at Medscape and WebMD and elsewhere about burnout among physicians, among nurses, among pharmacists. But what about laboratory personnel in terms of the burnout there? How concerned should we be about burnout and laboratory personnel?

Sause: I first want to say that the lab personnel in the United States are really unsung heroes of the pandemic. We were talking about the millions and millions of PCR tests that were run during the pandemic. There's a person behind all of those. And I do really want to recognize the incredible work they did.

With that said, as all healthcare workers, they're under the same pressures in terms of staffing, like you mentioned, doctors and nurses. There was a challenge with staffing a lot of clinical laboratories even before the pandemic based on a wave of coming retirement. And I think now with the pandemic, that's even more of a challenging situation.

One of the things we've done is we've invested significantly in, like we said, automation and standardization of our laboratory equipment. What you see around us is next level in terms of the automation that we're able to bring to the clinical lab, allowing those laboratorians to focus their resources on the most critical tasks and not repetitive, manual labor, like in the past. That's something we're also really proud of — how we've innovated the delivery of diagnostics on top of the biomarkers that we've also invested significantly in.

Whyte: Has COVID changed that perspective of partnership? Everyone I've been talking to has been saying "partnership," to be fair. That's not what it was like pre-pandemic, was it? It was really kind of more…everyone was kind of isolated. Do you think these partnerships are going to continue in a post-pandemic world?

Sause: It's an interesting question, and I maybe don't have the juxtaposition for contrast, because I started this job right before the pandemic started. So I jumped right into the fire. It was — there's no other way to say it, John — well, there is. For myself, initially I had incredibly positive interactions with both the FDA as well as the federal government and how we made sure we got tests to the folks that needed them the most. And so, moving forward, we also had a tremendous collaboration with Francis Collins' RADx program at NIH for getting rapid antigen tests for patient self-testing into the home. It was a research collaboration that allowed us to do the clinical development for that test together with the federal government.

Whyte: And that's a success story that we often don't hear about.

Sause: Absolutely. I can be relatively sure that those kind of collaborations didn't happen before the pandemic. Will they still happen? I'd like to believe they will. For emerging pathogens like monkeypox, we've been highly engaged with the federal government there. And I would like to hope that COVID was a catharsis for how we view these kind of public-private partnerships between industry and the US government in terms of best taking care of the needs of our population.

Whyte: Are we better prepared for the next pandemic? I'm not saying that monkeypox is the next pandemic; you mentioned monkeypox, but are we better prepared? What are the lessons learned?

Sause: We've built an incredible infrastructure for testing now in the United States. All of this investment, this RADx investment, as well as the private industry's tremendous investment in testing has really led to a rejuvenation of the infrastructure for testing in the United States. I think that's an important part of it. I think the awareness of how you need to roll a test out very quickly and get ahead, like you said — the first step is testing. I think there's a broad awareness of that. So for me that's really critical, and we actually authored a white paper that we presented to the US government on preparing for the next pandemic.

Whyte: What's the future of diagnostics? Let's not look 10 years in the future. Give me your perspective of what it's going to be like 3 years from now? Is it going to be all without puncture of any body part or vein? Is it mostly going to be done in the home? Will much of it be virtually with digital apps? What does the future look like, Matt, for diagnostics?

Sause: That's a great question, John.

Whyte: Take out your crystal ball.

Sause: Looking around the room at all this automation, I think what we're going to see is a migration of the modality to the setting in which it most benefits the patient. We look at things like COVID home-testing. I would also imagine a similar migration for things like sexually transmitted infection (STI) testing, which is a lot of times done in public health laboratories.

Whyte: People don't often come in because they're embarrassed or because of access.

Sause: Precisely. And I think the ability to move that closer to the patient would really help identify more individuals, which would then decrease the spread and decrease the societal burden.

We spoke a little bit about neurologic diseases like Alzheimer's. One in 9 individuals over the age of 65 is living with Alzheimer's. That burden is just going to grow into the future. So I think that integration of those biomarkers into diagnostic testing modality is going to become a critical part of the near future. But the convergence of some of these technologies, we call it multiomics: existing protein biomarkers, DNA sequencing, fragmentomics, looking at the circulating tumor DNA that's released from tumors in the cell, bringing those together for early cancer diagnosis. I think there's tremendous opportunity,

Whyte: You're catching it at 10, 20 cells in theory, vs 600,000 cells when someone presents — that's what's exciting.

Sause: Exactly. And I think these technologies also have the ability to monitor disease over time. So if you diagnose disease early, having what's called minimal residual disease detection for these tumors and then being able to reach endpoints in new clinical trials for new modalities of treatment, you have a surrogate to overall survival, disease-free survival at a certain point, which enables clinical investigation of new drugs and also then enables better management of symptoms if you're able to do it from a blood draw.

Whyte: You wake up every morning, what's on your mind?

Sause: Yeah, I wake up every morning, I think the thing on my mind is how we make this all come together and how we make it happen. We've talked about a lot of these technologies that are very far-reaching in nature, and getting the team to come together. In the past, a lot of our different functions worked in silos. And in order to execute this, what you talked about — access, changing practice guidelines, and then delivering and executing on the investigation — requires an orchestration of a lot of functions that maybe we didn't have to do in the past. So for me really, how we bring those together is what I wake up thinking.

Whyte: But now your job's easier now.

Sause: Exactly. Thanks, John. It's so much easier. But how we get those teams to work in concert that's what's on my mind.

Whyte: What do you tell viewers who are watching about diagnostics? What do they need to know today?

Sause: I think what they should know is that for us as a society, embracing the use of diagnostic testing and biomarkers has the potential to help us all lead healthier lives. I think that's really something that we all should embrace. It's not like an intervention, like a pharmacologic intervention. It allows us to make better choices about how we live and what kind of care we receive. And hopefully that has a benefit on humankind.

Whyte: Absolutely. It's the first step that we all need to take in terms of treating disease and preventing disease.

Matt, I want to thank you for taking the time today and telling us how the diagnostics industry has been changing as well as what we can expect in the future.

Sause: Thanks, John. It was a great conversation. I really appreciate your time today.

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