From Lab to Launch by Qualio
From Lab to Launch by Qualio
Sepsis Detection Made Rapid and Accurate with Dr. Rolland Carlson CEO of Immunexpress
Join us with guest Dr. Rolland Carlson, CEO of Immunexpress to talk about the transformative work happening in sepsis diagnosis.
Dr. Carlson discusses the importance of rapid sepsis diagnosis. The episode covers challenges faced during product development, regulatory achievements, and future plans for sepsis diagnostics. Dr. Carlson also shares advice on ensuring product quality and navigating FDA clearances.
00:00 Introduction to From Lab to Launch
00:25 Meet Dr. Rolland Carlson, CEO of Immunexpress
01:31 Challenges and Innovations in Sepsis Diagnosis
03:01 Impact of COVID-19 on Clinical Trials
04:17 The Vision Behind Septicite Rapid
05:17 Technical Insights into Sepsis Diagnosis
14:00 Regulatory Achievements and Quality Management
16:58 Integrating Septicite Rapid in Clinical Workflows
24:00 Future Innovations in Sepsis Diagnostics
25:34 A Personal Note from Dr. Carlson
26:29 Conclusion and Farewell
https://immunexpress.com/
https://www.linkedin.com/in/rollie-carlson-ph-d-059074a/
Qualio website:
https://www.qualio.com/
Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast
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Music by keldez
Hi there! Welcome to the From Lab to Launch podcast by Qualio, where we share inspiring stories from the people on the front lines of life sciences. Tune in and leave inspired to bring your life saving products to the world.
Meg Sinclair:Welcome to another episode of From Lab to Launch by Polyo, where we delve into the latest innovations and insights from the life science industry. I'm Meg, your host, and today we're thrilled to have Dr. Roland Carlson, the CEO of Immunexpress with us. Raleigh has been at the forefront of transforming sepsis diagnosis. It's a critical condition responsible for millions of deaths and significant health care costs globally. Rapid and accurate diagnosis is paramount, and Immune Express has developed a diagnostic tool that significantly enhances the ability to differentiate sepsis from non infectious inflammation within an hour. Raleigh has over 25 years in biotechnology, serving as CEO a few times, and held key roles at Abbott Laboratories, and this is Inc in molecular diagnostics and business development. You can see his full bio in the show notes. Septicite Rapid, supported by extensive clinical trials and peer reviewed publications, has received FDA 510k clearance, CE marking, and approval from the Australian Therapeutic Goods Administration. Welcome, Raleigh.
Dr. Rollie Carlson:Matt, great to be here. Thank you.
Meg Sinclair:Thanks. So you've been the CEO of Immune Express for over six years. Can you tell us briefly how you got connected to the company and what it was like leading through COVID? Um, it was probably a disruptive time for the business, as I imagine.
Dr. Rollie Carlson:As it was for everybody, I'm sure. Yes. Yeah, I, um, I joined the company actually, uh, after a career at Abbott, as you mentioned, where I was head both by, uh, Diagnostics and pharmaceutical responsibilities. And I, I left Abbott to join the entrepreneurial world. So, um, and I left for startups in Austin, Texas, and we founded a company called Assurgen, which now has been purchased by Biotechni, and later a Nasdaq CEO company for Wafergen Biosciences, and now Immune Express. Um, I knew Immune Express as in my company in Austin. We had built a assay based upon their novel gene markers for for sepsis, and they wanted to have a system by which they could do clinical testing for. So I was introduced to the company that way, um, and, uh, and after my stint at WaverGen, I was gainfully unemployed and the board was looking for some changes of leadership. And so they asked me to be the advisor and one thing led to another. I came on as CEO.
Meg Sinclair:Stars aligned.
Dr. Rollie Carlson:Yes. Um,
Meg Sinclair:yeah. And what kind of challenges did you all face during? COVID.
Dr. Rollie Carlson:Well, with COVID, I think, as we were in the middle of our, uh, clinical trials associated with our, our diagnostic, we developed a product and we were quite bullish about, you know, from a time, you know, not only fundraising, but then also getting FDA clearance and COVID put a wrench in the works quite a bit. Uh, not only did it slow down, obviously hospitals were, were, you know, The front line was COVID management at that point in time and doing clinical work was not, um, that high in their priority. And so, um, however, we knew that the test and we had developed and did studies in, in, in Europe very quickly that found that the test was very usable for COVID induced sepsis, you know, as, as a result, so I delayed our clinical trials for probably a good year. And then also we filed for the FDA. And of course, they were looking at approvals for COVID products. And so, um, that delayed us a good another nine months or so. And so, but we were fortunate. We were the first non COVID product in infectious disease to get cleared by the FDA, uh, coming out the other end. And so, uh, we were very pleased with
Meg Sinclair:that. Lots of stars aligning on your side there. Right. Uh, so septicite. Rapid is a groundbreaking tool in sepsis diagnosis. Can you share with us the inspiration and initial vision behind the development?
Dr. Rollie Carlson:Yes. Well, sepsis is really a conundrum, you know, where it's one of the leading causes of death in hot U. S. Hospitals. Uh, there's been some improvement as far as mortality and morbidity, but it's very difficult to diagnose. And so physicians actually relying on pretty archaic, uh, uh, technologies from 100 years ago of doing blood cultures and waiting for 24 or 48 hours to see if they can get a result. And many times they don't get a result. So, you know, physicians are really challenged to have a multitude of inputs and to try to diagnose sepsis early. It's easy to diagnose sepsis. Uh, when it leads to, uh, organ failure and, uh, and somebody's in dire, dire straits. However, early detection of sepsis is, is, is quite difficult. So therefore, there's a lot of judgment that physicians have as a consequence of that. So the vision of our, our, our technology was to actually develop a test that could be rapidly diagnosed. sepsis in the early stage and be able to intervene with the appropriate patients who are septic. But many times, 42 percent of the time, physicians believe it's sepsis, but it's not. So both ruling in and ruling out sepsis is very, very important because it could be these people are sick. There's some other ideology. They should be treated for something else, or they should look for something. So the way to do that, which historically has been to look for pathogens, requires a number of copy numbers of a bacteria or virus or path or fungus to grow. And what we were measuring and we found that the human, uh, substance is really dysregulated, uh, systemic inflammatory response syndrome as a result to a pathogen infection. And what that starts is your, your, your, your body is actually hyper immuno reacting to the pathogen. And it's really that hyper immune response that actually leads to cascade and ultimately, you know, high morbidity or more mortality. And so what it was important to do. There's systemic inflammatory response with no pathogen. It's ephemeral. If you were in a car accident or you had chronic pancreatitis, you might have symptoms of systemic inflammatory response. And what we developed was actually measuring the human response from like blood cells with a highly sensitive M. R. N. A. QPCR test that measures differential expression of these genes. And these genes, what they're able to do is, uh, on some in the presence of a pathogen or highly upregulated. And the other one is not. And then if there's not a pathogen, then the one gene is quite stable. And the other one is actually, uh, lower expressed. So we can measure it. Uh, the algorithm, uh, and that spits out a score of the probability of sepsis from high to low.
Meg Sinclair:Great. And how is the speed important here with this new testing compared to the old archaic methods?
Dr. Rollie Carlson:Well, um, the, it's pretty well known that if somebody does have sepsis, uh, as each hour goes by, the increased probability of mortality goes up by 8%. So if you're waiting for 12 hours or so, yeah, obviously that's a problem. And so, uh, it was important when we did our market research is that you needed to have a test. And the test, by the way, that I originally, uh, developed in my former company for the for immune express was on a conventional molecular platform, which was a plate based one, which would take about 8 to 12 hours. And they were looking at retrospectively what was the diagnosis and found a high correlation. But for, from a marketability standpoint, you really had to have something that could Have a result within one to two hours. And so that was part of our design goals for the test that we have, uh, such a site rapid, uh, which is a sample to answer, um, uh, product and, uh, very easy to use. And we can have a turnaround time in one hour.
Meg Sinclair:That's a big difference from eight hours.
Dr. Rollie Carlson:Absolutely. That's
Meg Sinclair:such an improvement in patient outcomes, I can imagine.
Dr. Rollie Carlson:Indeed. Indeed.
Meg Sinclair:What else, um, with the subcyte rapid performance compares to other biomarkers that you can share with us?
Dr. Rollie Carlson:Well, there's a number of, there's a number of biomarkers and there's other sort of symptomology, you know, that, uh, that. In clinical, clinical signs that that physicians look at. And in sepsis it's probably about 12, uh, 12 of them, you know, it'd be fever, high blood, white blood count, uh, uh, low lactate levels. Lactate is is something that's used that's more about, uh, perfusion and make sure that you have the appropriate sort of fluids associated with that. Um, and other biomarkers are nonspecific. In other words, there's there's some procalcitonin, which is actually a a a marker that is very specific for bacterial infection and is not used. It's used indirectly for sepsis detection, but Uh, it's it's labeled for actually withdrawal of antibiotics. If somebody is responding to that, uh, CRP is also used in some occasions. But what they have to do is really take all of those together and be able to come up with a result. And in our clinical trials, what we did was we looked at our septus score result, which is the result that we get from our test compared to all those other variables. And it was Uh, well, well, when you combine those variables together, then you get a, uh, an improved performance. The CEPA score alone, uh, was actually superior to all those combined. Um, so, um, instead of a physician having to do a multifactorial in their head of those 12 different things, then they should be able to have that score. Now, You know, you do need to look at those other variables because every, every, uh, every patient has sort of a unique situation. And so, um, but, and so what we look at is if there's two sides of that systemic inflammatory response, uh, and, and physician is suspicious of sepsis, then you should do a blood draw, um, and which normally they would do for cultures. At the same time, they should do this for cultures. our test. And what we found was that, you know, within an hour, you could have the result with a very high correlation. If it led to a positive blood culture, we had a very high, probably high correlation with blood cultures. But we have that result within an hour where you had to wait for 24 hours for the blood test.
Meg Sinclair:And time is of the essence with sepsis. So that's amazing. Well, we talked a little bit about your challenges with COVID. What are some of the most significant challenges you faced in the development and clinical validation of septicide rapid?
Dr. Rollie Carlson:Well, in my career, and I'm sure that, you know, your, your listeners, as well. If you're looking at a product that's, um, you're trying to develop and, and you're actually looking at something that is maybe a better mousetrap, maybe it's faster, cheaper, whatever for an existing, the existing product, the, uh, what I'll call the product market fit is, is pretty well defined. Okay. So, uh, if you have a better oncology test, something that's faster, You know, for EGFR, K RAS or something along those lines are easier to handle. So that, that is fairly straightforward. But when you get to a, a product, which is, which is in a space that is novel and, and there isn't a fixed application, then that product market fit is very important to understand early in the process, uh, because, You can go down and think, you know, internally believe that, you know, this is the best thing since sliced bread. But as a matter of fact, are you really fulfilling a customer need? So you have to do the market research up front. You need to make sure that your design goals fit that. And you have to be pretty rigid about that. Is, is, do you meet those or not? For example, if we were trying to develop a subsite rapid and, um, it took three hours instead of one hour. Then you know what? We usually go back to the drawing board. Don't try to go out with three hour test, you know, uh, in in that regard. And then the other thing is, it's a do the market research up front. And then, uh, and and I think that as you're doing In the IBD world in diagnostics, it's different than what you're doing for a CLIA test, for sure. Uh, you need to be able to lock down what the specifications are for getting FDA clearance and uh, other, other clearances. And many times, companies, because of the rush to try to get the product out, will lock down those design goals. Too early, and then they get down the process and, uh, they might find that manufacturability is a problem. Things along those lines. Mm-Hmm. So, um, my philosophy, which I've learned the hard way, is stay in phys feasibility as long as you can to make sure that you've asked the hard questions that you're able to over, you know, achieve as far as those, those goals are concerned. And then actually it's very easy to go through that design process.
Meg Sinclair:Great advice. Speaking of your 510k clearance and CE marking, you've also gotten the Australian Therapeutics Goods Administration approval. That's quite the regulatory, um, quality achievements and quality management is at the heart of what we do here at Qualio, so have to ask, um, how does Immunexpress ensure the reliability and accuracy of your products and instill a quality of culture?
Dr. Rollie Carlson:Well, I think that number one, I mean, if you're in this business, you have to aspire to have the highest quality to fulfill your customers. And we're talking about serious, you know, medical devices and diagnoses, and you have to ensure that you're providing your customers and your patients, you know, quite frankly, the highest quality product. Um, I had the benefit of Of learning within the Abbott system, so to speak, you know that you needed to really have being lockstep with quality quality regulatory early on in the process, and particularly for founders. And I've worked with founders who had That it might, for example, the company in Austin that I joined, the co founder there was, you know, a fantastic scientist and very successful in the life science world and had never done anything in the quality regulatory sort of, uh, and the appreciation of that, you know, one tends to discount if you haven't gone through that, but that can come back clearly to, uh, be, be an issue. So, uh, engaging quality and regulatory, which I, You know, as as key members of the team, not just something that you sort of throw over the wall. You can't do that to be successful, you know, in that regard. And I've been very proud of the team that we have, you know, in achieving the accomplishments we've had. We have at the Express, they're experience both domestically and internationally. And, you know, if you work with the agencies up front too, um, and making sure that you, in some cases, and particularly in this situation where you have a novel product like Ceptoside Rapid, you need to go through and engage the agency early on and saying, this is what we're planning on doing. Do you have the input before we spend, you know, millions of dollars on clinical trials, et cetera.
Meg Sinclair:Yeah, great advice. Those early FDA meetings are always worth having, especially with those novel devices to, to know where you need to chart your map.
Dr. Rollie Carlson:Indeed. And sometimes you get feedback that you don't, you really don't want to hear, but it's very important to get that early on because if you spend, you know, uh, your investors money and you have expectations for clearances and, and you have a, um, a hiccup. And I think there's some experiences, you know, fairly recently with companies where they went all the way down the path and they couldn't get FDA clearance. And that obviously, uh,
Meg Sinclair:Yeah, too late to pivot at that point. So exactly. How does stuff to say rapid test integrate with current clinical workflows in hospitals and what feedback have you received thus far from healthcare providers?
Dr. Rollie Carlson:Well, what we found with sepsis, and not only in Europe and the U. S., it's, it's managed very differently by different institutions, uh, but, and, and there's many sort of stakeholders associated with sepsis management. If you're trying to be able to identify sepsis in the emergency room, uh, department, then what you're trying to do is, you you know, quickly rule in, rule out in that. Um, our test is really not for screening, you know, a patient who might come in with a fever and and looks a little a little sick or so. It's really somebody that's strong, especially suspected of being sepsis. And you know what? The different stakeholders associated with sepsis management are going to be, uh, critical care, uh, patients. doctors, nurses, E. D. Doc. That's going to be doing the admissions. And then ultimately, um, you know, the infectious disease, uh, doctor that after patient is is admitted. And what happens is initially there's gonna be an order set. Different hospitals will say, if I suspect, uh, that there's going to be a patient of substance, they'll say, I want to, uh, uh, draw blood for lactates for a look at, uh, WBC, white blood cell counts. Uh, and they call these things, uh, sepsis bundles, and there are sort of three or four key criteria, um, by which they're going to react to. And the, uh, there are, there are international guidelines associated with that, uh, but they're, you know, they are not something that everybody follows. Um, in the U. S. C. M. S. Has actually, uh, been pretty prescriptive as far as what they call, uh, set one bundles where if you suspect somebody to have, uh, substance, you need to either you need to either administer antibiotics and treat them within three hours or not. And you need to know one. Is there an infection? And two, is there is a systemic inflammatory response, which is exactly what our test does. So as we what we're doing is we're when we approach customers. What one? What is what are you doing for sepsis? Uh, to what is your need? Because in some cases, you know, it's the inpatient sepsis. That's their biggest problem. They got their process for admitting etcetera like that into. But when a patient ends up in the hospital, then what? What? What happens? And to them and in other cases, we have too many people coming through the E. D. We can't answer that. We can't triage them fast enough. So we want to be able to bucket them. You know, that's, that's associated with it. So we, we try to, uh, and many, um, hospitals want to do an evaluation. I mean, for us, it's important to do an evaluation to try to meet their unmet, their unmet need. Right. So that's, that's, that's our approach, right? I think that we, our test really helps drive compliance to, uh, uh, the CMS, uh, substance bundles, you know, and I think there's a good recognition from, um, uh, from hospitals associated with that. Um, and I think that as we have used the test is being used, there's some interesting you know, results. First off, I made that comment about 42 percent of the time physician thinks it's sepsis. It's not so that's being verified. And so, uh, major customers are saying, Wow, we're really surprised how many people we thought had such a stone, you know. But then, on the other hand, Uh, there's, they're saying, wow, you guys really highly correlate with blood culture if it's positive and we're ruling in another use case would be post surgery. If you have patients that are having having surgery, there'll be the surgical ICU. There's a lot of concern about infection. Um, and and can they be really discharged to the ward for for recovery and looking at our test as far as ruling rule out is important. And if they if our test is positive, and I'm not sure if your listeners are aware, but right now there's a blood culture bottle shortage right now that the FDA has put out notice for. Um, and the blood culture industry is still very, very large. Um, but right now there's a shortage of that. And what we found was, is that with our test for positive, actually, you would like to double up your blood cultures, uh, causative organism, whether it's, you know, you know, you know, that there might be going down sepsis, you start treatment, but then you want to find the cause of uh, But on the other hand, if, uh, if we have a low probability, it does a testing, then, uh, perhaps you shouldn't be having to administer all those blood cultures and you should be, you should, uh, be looking for something.
Meg Sinclair:Back to that 42 percent that you mentioned of doctors thinking it's sepsis when it's not, um, how does that play into being good stewards for antibiotic stewardship and fighting against antibiotic resistance?
Dr. Rollie Carlson:a very good question. And it's one where, you know, antibiotic and the other thing is E. M. S. Is actually looking for compliance to, uh, you know, um, antibiotic utilization, you know, as because I think as your listeners probably are aware of, you know, the basically, uh, resistant organisms have been hospital, uh, are is a big, big problem. And quite frankly, um, it's anticipated the number of deaths associated with, um, you know, and, you know, antibiotic resistant organisms is going to exceed those of cancer deaths by 2050. So this is something that very much needs to be, to be addressed. But I understand the situation, you know, the physicians are, are certainly in, in that they don't want to. Uh, patients, they don't want to miss a patient. You know, if they believe it's sepsis, their only recourse, I'm not really sure, but my default is I'm just going to be able to put them on antibiotics. And I think that, and, and, and frankly, it's up to us in the biotech world to come up with solutions to help them give them the tools to provide this selection criteria, you know, uh, and these are busy people, you know, they're very, very smart. They know what they're doing, but they, they have. If they have limited tools, uh, then they're going to stay with what they do.
Meg Sinclair:Yeah, to stay that conservative approach and treats. It's amazing work that you all are doing. Um, looking ahead, what are your future plans for future developments or new innovations in the field of sepsis diagnostics or beyond?
Dr. Rollie Carlson:Well, I think with sepsis, uh, with sepsis, you know, faster. Cheaper is very, you know, always, always useful. Uh, our next generation product is set aside rapid B. D. Bacterial viral. So in a single cartridge of which we, uh, basically, you know, in my hand, I'm holding, uh, I'm like a lab in my hand here. And this has got all the reagents, everything that's necessary for extracting, purifying, uh, the, uh, um, the genes and then find them and being able to have a, have a, uh, report out and to that, for the question that happens is okay. If sepsis in our test, by the way, so sepsis that could be based on viral, okay. As I said, the coven bacterial or fungal, and we just have found for parasitology as well. But the main drivers are back bacteria and viral. And so there are tests that we're combining genes host response genes that basically you're saying if it's sepsis, then is a bacterial or viral and you'll have that same result at the same time. So that's what we're doing. We're expanding also into pediatric indications. And I think, you know, combining this with You know, direct detection of pathogens in the future will be very, very,
Meg Sinclair:I can't wait to see what y'all do next. Well, Raleigh, our last question is more of a fun one. We like to ask each of our guests if we ran into you at the bookstore or at a local library, in what section would we find you?
Dr. Rollie Carlson:Well, you know, my PhD, I'm actually a plant biochemist that, uh, that, that that focused on marine biotoxins. And so I love to dive. I love the ocean. I love anything above or below the ocean. So you'll find me either in the sort of, uh, ocean, oceanography, uh, certainly the, uh, the marine environment, etcetera along those lines. So, uh, and quite frankly, I I love geography. I love history. Uh, but my passion, you know, outside of, outside of what I do for work is certainly water oriented.
Meg Sinclair:I'm a former ocean girl myself. So I love the ocean too. Yeah. Well, it was great to have you on the show today. Where can people go to learn more and follow along and connect with you, Raleigh?
Dr. Rollie Carlson:Well, you can look up our product at septicite. com Uh, and certainly the company is immune express, uh, com.
Meg Sinclair:Terrific. Thanks so much, Raleigh. It was a pleasure.
Dr. Rollie Carlson:Enjoy it, man. Take care.
Meg Sinclair:Thank you.
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