Lumos Diagnostics Holdings Limited (LDX) Earnings Call Transcript & Summary

Thank you for joining us today for this outpatient- focused webinar hosted by Lumos Diagnostics as an Antibiotic Stewardship Sponsor of the Urgent Care Association. Today's session will also feature real-world insights from WellStreet Urgent Care, one of the nation's leading urgent care organizations. My name is Amelia Stephens, and I'm the Global Marketing Consultant for Lumos Diagnostics. I'll be moderating today's session, welcome. Today's webinar is titled reducing diagnostic uncertainty, Rapid evidence-based antibiotics stewardship and outpatient care. Today's discussion will focus on stewardship solutions for outpatient settings. Particularly during peak respiratory season when overlapping symptoms are heightened and patient volume surge. Next slide, please, image in. We're also joined today by Annie Bell, Vice President of Medical Affairs at Lumos Diagnostics. Annie leads clinical strategy and clinical research for Lumos' rapid diagnostic technologies and has contributed to multiple peer-reviewed clinical studies on FebriDx. With expertise in clinical research, host response biomarkers, infectious disease, respiratory diagnostics and antimicrobial stewardship and he works closely with clinicians to evaluate and implement tools that improve diagnostic accuracy and patient outcomes. Today, Annie will walk us through the clinical evidence behind FebriDx and explain how rapid diagnostics can support evidence-based antibiotic decision-making during the initial patient visit. We're also joined today by Dr. Brian Bobb, Senior Medical Officer at WellStreet Urgent Care, one of the nation's leading urgent care networks. In this role, Dr. Bobb oversees quality improvement, provider and education and clinical pathway development across high-volume centers. His work focuses on reducing unnecessary antibiotic use improving diagnostic confidence and enhancing care consistency, especially during high-volume seasons. Today, Dr. Bobb will share real-world insights from WellStreet's implementation of FebriDx, including how rapid point-of-care testing was integrated into urgent care workflows. Today -- together, our speakers will connect real-world urgent care experience with the clinical evidence behind rapid diagnostics and share practical insights on how antibiotic stewardship strategies can be implemented without disrupting workflow. During today's session, if you feel that you've heard something that could make a meaningful difference in your outpatient settings, we'd love to continue this conversation and hear from you. You'll find a link to the chat to short form simply share your details and a member of our team to get in touch with you for an initial no obligation conversation. Thank you. Also if you do have any questions during today's session, we encourage you to submit them using the Q&A feature. You can also access this by heading to the Zoom toolbar selecting more and then clicking Q&A. We'll cover as many questions as we can during the Q&A at the end of the session. With that, let's get started. Annie Bell is going to begin to walk us through with the global mortality and cost burden of antimicrobial assistance, setting the foundation for today's discussion on stewardship and outpatient care in the next slide. Thank you.

Thanks, Amelia, and thanks, everyone, for joining today. I know everyone has a busy day, so I appreciate your time and effort to be here. So unnecessary antibiotic use is driving antibiotic resistance. It leads to approximately 1.3 million deaths worldwide each year, and it affects every part of health care. In the U.S. alone, you can advance the resistant infections add over $20 billion in health care costs. Next slide, please. This is training the system through additional testing and adding time and complexity to already overburdened workflows. From a patient perspective, resistant infections lead to prolonged recovery times, loss of productivity and often cause other negative health [ sequela ] as a result of the impact of resistant infections. A major contributor to resistance is how often antibiotics are prescribed in acute respiratory infection, things like cost, sore throats, congestion are the most common reason patients seek health care and are oftentimes nonbacterial and origin and do not need nor benefit from antibiotics. That said, over 50% of cases result in an antibiotic prescription. And a lot of that comes down to diagnostic uncertainty and patient expectations. So it can be difficult to differentiate bacterial from nonbacterial etiology in a short visit when signs and symptoms overlap and there's also often an expectation by patients that they'll leave with an antibiotic regardless of the cause of their reason for presentation. And they don't necessarily appreciate that there can be negative effects associated with antibiotics when you don't need them. So together, those pressures are fueling unnecessary antibiotics, prescriptions, fueling resistance and are adding to overall health care costs and preventable resistant infections. Next slide.

Thank you, Annie, for walking us through the broader challenges and why stewardship matters in outpatient settings. Now we're going to narrow the conversation down to outpatient settings for providers feel these pressures every day, especially during high-volume seasons like we find ourselves in right now. Dr. Brian Bobb will start us off with a quick poll, so we can hear directly about the challenges you're facing day-to-day. Thank you.

Thank you, Amelia, and Annie for this kind of introduction. But as I'm sure you are all aware, we're in the middle of one of the busier flu seasons that we've had in a while, and I'm sure that you're facing these challenges. So we really want to get a sense of what you're seeing. I see people jumping into the pole already. What is the challenge? What is the biggest thing that you're facing in your centers. Obviously, the volume question is probably what a lot of us anticipate being one of the big drivers of stress and one of the biggest concerns for our clinicians, I see that one is popping up quite a bit, as well as the reason for this presentation, which is determining that bacterial versus nonbacterial etiology. And not surprisingly, we're seeing a lot of responses that they kind of filter into those categories. Feel free if you have other things that don't fit into the 4 selections that are there to enter your own responses. We want to make sure we get a chance to review those and consider those even at the conclusion of the webinar. So I think it looks like we've got a good number of participants there. That have entered their responses and pretty evenly distributed between the 4 responses with maybe the limited access being a little bit lower on the list. And I think that's something that has evolved over time. And even though we know that overall in the outpatient setting, there are fewer point-of-care diagnostic tests that are being used urgent care probably is skewed a little bit to the higher end of that spectrum because of the role that we play. So I think we can end the poll now and move on to the next slide there, [ Amelia ] if you're ready to pull that one up? So again, these are the questions that we look at, what are the biggest challenges, the difficulty in differentiating the bacteria versus nonbacterial. The high volume that we're facing during this season and the unpredictability of which location might be hit harder on a given day, limited access to those diagnostics. And then the patient expectations. So we really wanted to touch on those things a little bit from what we have seen in our own experience and what I've seen over 20-plus years in the industry as well. If we move on to the next slide, we can talk a little bit about what kind of drove our decision to look into a tool like FebriDx and what pressures you all may be facing as well. As we all know, during this season, we're flexing up. We're seeing sometimes 40 to 60 respiratory patients per day per clinician in some centers that can be 3 or 4x that much when you have the additional clinicians working there and the kind of pressure and chaos that, that can lead to. And then you have the goal of getting those patients cared for and giving them the kind of answers and confidence that you want to deliver at an efficient pace and based on what the expectations of retail medicine are. So you've got that 15, sometimes last minute time period to spend with the patient, you're spending over half of that time, uncertain about what the diagnosis is and trying to figure out the next step. And as I alluded to before, the point-of-care testing piece, we may be a little skewed to the higher end of that in the urgent care setting compared to the rest of the outpace or ambulatory world. But there is some limitation there in what tools we have that are going to help us really definitively give the patient that answer so that we're not doing that fourth thing, which is guessing when we're prescribing and inappropriately adding antibiotics to the mix or missing an opportunity to treat with an antiviral that might help for somebody who's in a high-risk situation. So those are the sorts of challenges that we were considering when looking at this as an option. And I'd like to pass it back so that we can talk a little bit about what FebriDx is, and then we can get into what we saw in our setting in within WellStreet and specifically within the Piedmont Urgent Care situation that we tested the product adding.

Thank you, Dr. Bobb, for walking us through the real-world pain points and challenges in outpatient settings. We're going to turn it back to Annie Bell, who's going to take us through FebriDx and its benefits for antibiotic stewardship.

Great. So FebriDx is a rapid point-of-care immunoassay that aids in differentiating bacterial from nonbacterial etiology in patients who present with symptoms of acute respiratory infection. So as you can see here, it's an all-in-one integrated device that's instrument-free and delivers results after about 10 minutes. So it can be very helpful in the discussions right in the patient visit regarding the underlying cause of infection and maybe the best course of action in terms of treatment for that patient. So it serves as a visual tool to facilitate those discussions. FebriDx was evaluated -- FebriDx was evaluated a large multicenter trial that compared FebriDx to a composite algorithm to determine diagnostic accuracy. FebriDx was found to have a sensitivity or a positive percent agreement, what you see here as PPA of 93% and a negative predictive value of 99%. So it's very good at both detecting and blowing out bacterial infection in the patient business. So that again, the clinicians can have those discussions right when they're most relevant with patients. FebriDx is currently cleared for moderate to high complexity in moderate to high complexity settings, and we have a CLIA waiver under review with the FDA currently. We can go to the next slide. Okay. So FebriDx works by using 2 host-response biomarkers. So C-reactive protein, or CRP, and mix of virus-resistant Protein A or MxA for short. That's mouthful. CRP is a nonspecific acute-phase protein that's upregulated in response to acute inflammation, including response to infection. So it's predominantly produced by the liver in response to inflammatory cytokines and assist in pathogen recognition. CRP has a fast induction time, which is relevant for this patient population as they may present early in their course of infection. And it's noted to be very sensitive. So you may know or have some experience with CRP already. And it's a very sensitive by marker, but lacks specificity. MxA, on the other hand, is highly sensitive for viral infection. So it is part of the innate immune response to viral infection is upregulated in response to type 1 interferons, which are produced as a first line of defense in response to bioservices. So it has both immune modulating and antiviral functions in the presence of a viral infection. And most, I guess, importantly and relevant to this conversation is it's not upregulated in bacterial infection. So it doesn't respond to the inflammatory cytokines that stimulate inflammatory response to bacterial infection. And healthy individuals have very low levels of MxA. So and that also has a quick induction time much like CRP in that sense so that if patients are presenting early in their course of disease, MxA should be outdated if there's a virus present. And so individually, these 2 biomarkers are neither sensitive nor specific enough to add diagnostic certainty to the conversation. However, when paired together, they have very good sensitivity and specificity for detecting and rolling out bacterial infection. So clinicians can have the conversation with confidence right in the patients appointment about what's the underlying cause of infection and what's the best course of management and exactly their appoint. So if we go to the next slide. So FebriDx is very simple to use. It uses fingerstick blood in a very small amount of 5 microliters. And like I said, the device is an all-in-one integrated device. It has the lancet the blood collection tube, the and buffers all integrated into the test as well as the test strip. So the first thing we do, of course, is clean finger and then remove the -- in step 3, the protective green covering, which is covering the sterile lancet. And the lancet is just a small needle. It's not a blade. So it's very well tolerated by patients. And so we removed the protective lancet and lands the finger using the spring-loaded lancet. Like way the first drop of blood and then in step 5, we collect like a good drop of blood. So a good drop of blood will get you the 5 microliters. The blood collection tube works via capillary action. So as long as it's touching the blood, it will drive right into the blood collection tube, and then once it's full in [ step 8 ] we rotate the arm on to the test strip. And again, it's working by capillary actions. So once the collection tube is in contact with the test strip, the blood releases on to the test trip, and then once you verify that all the blood has released, then we deliver the buffer by pressing the buffer release button, buffers integrated into the test. And then the blood and the buffer start to flow across the test and results are ready in about 10 minutes. Okay. We can go to the next slide. So the test is very easy to perform, very easy to interpret. So once the blood has cleared the test strip and we verify that it's need all the way across then the test is ready to interpret. So the presence of a black gray line, which is the CRP biomarker and the blue control line is indicative of a bacterial infection. And notably, there's no red line there. So without MxA that is lack of a viral host immune response. Any presence of a red line in the next section here, is a nonbacterial etiology. And when the control line is there without any test line, that means there's no host immune response to either CRP or MxA. And so then this serves us like the visual tool that clinicians can use in the patient's visit to discuss the underlying cause of their presenting signs and symptoms and the best course of treatment recommendations that they have for the patients. Okay. That's -- we can go to the next slide, please.

Thank you, Annie, for giving that overview of FebriDx. Before I turn it over to Dr. Bobb who -- Dr. Bobb is going to explain how WellStreet Urgent Care is addressing antibiotic stewardship challenges with FebriDx. I just want to have a quick reminder that the Q&A section is still open. If you have questions about FebriDx please submit them, and we will be addressing this shortly in our next section after Dr. Bobb. Thank you so much. And Dr. Bobb, please take it away.

Yes, we can move on to that next slide imaging. So just taking a step back from FebriDx, I mean what we also always are trying to do is to make sure that we are providing the best care, obviously, for our patients giving our clinicians the best tools to work with. And so part of that is the education that we do ahead, ahead of time. So we want to make sure that there's robust education about antibiotic stewardship, both for our clinicians and our patients that we're having those discussions. We want to empower providers by giving them the tools they need in the center, the rapid diagnostic tools as well as the educational tools to address the concerns of the patients that they see every day. And I'm sure that's in line with the group on the webinar today and what you all are thinking about. And in doing that, we found that standardizing pathways across the clinics helps us to maintain consistency, helps us to manage flow during high-volume times. And then by doing things in a systematic way, we, therefore, also generate a lot of data that we can analyze about how things work to look at that in the kind of postmortem period, if you will, after visits. And after respiratory season to see how we did and evaluate that process and look for ways to improve. So when we think about that, we want to really look at that feedback that we're getting from the clinicians the feedback that patients are giving us, looking at quality metrics and the data to understand the challenges that we're facing. And then we want to target programming and other content to really hone in on the clinical skills for our clinicians to make sure that they are getting the latest information and feel comfortable and confident with how they approach things in the room with the patients and in the centers with the staff. And part of doing that is then to look at, okay, we've established what these needs are let's evaluate what tools are out there in the market and what things are available to us that we may not have had even just a few years ago, to help us along with our clinical training and experience to give the best recommendations and provide the best treatment for our patients. And then once we have those tools in place, we want to adopt protocols to apply those best practices and to kind of walk us through that initial patient contact all the way through to discharge in again, a systematic way and then engage the clinical teams and getting that feedback. So all of this comes together for myriad of the different problems we face. But clearly, in urgent care, respiratory season is kind of our playoffs in the Super Bowl season, if you will. And that's always when things are at their busiest and it's one of the primary roles that we hold in the health care community is helping with those surges that we see. Certainly, during this time of the year, but as we've seen with COVID that occurred throughout the year and how we differentiate different illnesses that come into play. So if you want to move to the next slide, we can talk a little bit about where FebriDx fit into that for us. As we were looking at again, antibiotic stewardship, making sure that we're doing the best for our teams and for our patients. Yes, we can step back to that previously. Then we determined that a product like this would be useful. And the question became, okay, how are we going to implement this? What would be the best way to approach our teams, again, by getting the understanding of where their pain points were and having discussion with the clinicians ahead of time. I think it really smooths over any concerns people have about a new test? Or where does this fit in to my workflow. So with FebriDx as it is now, as we await the CLIA Waiver, we needed to find a spot that it would work for us with a moderate complexity lab. And we had an opportunity in one of our busy clinics to do that. And because of that part of the workflow and because we were evaluating, we took a little bit different approach than what I'll kind of share with you on the next slide when we get there. And that is -- and I'm sorry, I know I said next slide, but I'm not quite ready for it yet, imaging. Sorry about that. So we started with, okay, what's this need to look like for us to really evaluate this? We want to check the patient and we want to understand what their symptoms are and then have a clinician involved early on. So again, we're getting a good sense of what the situations for the patient and how FebriDx a test like this could fit in. And so we did this at the triage stage when we -- when you understand a little bit of what's going on. We can get the test running again in 10 minutes, you have an answer. Is it bacterias? It non-bacterial? And then the clinician is able to come back and think through clinically, okay, do we have the answer that we need based on what we've seen? Do we need to consider other testing, whether it be rapid antigen testing for strep or COVID or flu or if this is a more severe case or a more complicated diagnostic picture would advance PCR panel be helpful. Are there other diagnostics that need to come into play. X-ray other things that you may have in your clinic. So that was kind of our initial workflow. And now if you want to go to that next slide image in. What we seen with that is, I mean, adoption was not a question at all. Our clinicians really saw pretty quickly the value in having that determination between bacterial and nonbacterial available to them early in the visit. It did help to differentiate where we might go with additional testing if needed. And it really gave our patients a confidence in the diagnosis they received. So what we're looking at for our next stage as we get to that CLIA waived status and expand this is to really put more of a standing order pathway into play so that when a patient comes in with an acute respiratory complaint cough or throat, fever congestion, our CSRs who are MAAs, do that quick evaluation as they're doing the intake, they go ahead and run the test. And as simply as Annie just described, get the test going and have that 10-minute time frame while they're finishing up the triage and intake portion to get the result in and have the clinician and consider the intake information, those results and often decide then before entering the room, okay, are there other tests we need to consider. And that, again, helps you to just manage that workflow in the clinic when you're dealing with these high-volume days. So then going in, again, having that piece of information in front of you, are we dealing with a bacterial illness? If so, do I need additional testing? Or do I know now what treatment I need to prescribe or if it's non-bacterial, okay, what other diagnoses do I need to be considering, again, are there other tests to consider? Are there antivirals, I should be considering? And in all of this, what other resources do I need to employ, whether it be just prescribing and clinical guidance? Or is there follow-up treatment that needs to occur based on the symptoms that are there. So FebriDx is really giving us an early look at early in the terms of the visit at what pathway we might be going down and helping the clinician to really think ahead and move efficiently through the process. When we think about not just what the patient experiences, but also from a clinician standpoint, taking out a lot of the uncertainty and the guesswork and the explaining the possibilities before you have an answer to a patient as opposed to coming in with a little bit more confidence of, okay, we're heading down this pathway versus another. I mean a lot of that just gives our clinicians a little bit more of a confidence going into the wrap-up of the visit and I think has helped a lot with some of the burnout that can occur during this time when you have just all of this uncertainty all of the time. So by taking that out, we've seen that group that's been working with the FebriDx product feel that increased confidence and comfort with the diagnostic process. So I know there's a lot to kind of explain where we've been, what we've kind of looked at to date and where we see this going. But honestly, going into it. As I said, we kind of evaluate these tools and think about, okay, how is this going to work, what's this pilot going to look like? And we go into it with different expectations. And honestly, there was this question of, okay, well, how does this fit in with other tools that we have? And is this going to be something that clinicians are going to really value. And what we did see was there weren't a lot of those questions about why are we doing this? Or where does this fit in, but it was more [Technical Difficulty] to use it, how can we make this more streamlined? How can we get the answer even earlier on in the visit. So it pretty quickly became clear to us that this is something that's going to be a useful tool for us in the long run. So that being said, I think we can move on to the next kind of set of questions here and think through Q&A and some of that. I'll let Amelia do that for us.

Thank you. Thank you, Dr. Bobb and Annie for the valuable overview of antibiotic stewardship best practices as well as the overview of FebriDx and implementation at WellStreet Urgent Care. We've gotten some great questions in the chat. So we're going to move right ahead to the Q&A section. If you haven't already, there is still an opportunity to add a question to the chat. We're going to do our best to get through as many questions as we can today. If we do not get to your question during this session, we will reach out to you directly and provide an answer. We really appreciate these thoughtful questions. When we get started, there's a great question for Dr. Bobb. Dr. Bobb, I know you touched on this slightly, but this is a great question to sort of summarize what you just were talking about with implementation. Did you have any barriers to adoption? And how did you handle these? What outcomes are you seeing from initial adoption for FebriDx?

Yes. No. And as I said, I mean, we kind of anticipated that there might be more resistance to just a new test and how do we put this into the workflow than we saw. But that being said, I think the way that we approach it and probably the reason we didn't see as much of that outside of just the utility of the test being pretty clear was laying the groundwork early and really going back to kind of our approach with involving clinicians in these decisions. I think that by having plenty of discussion in advance about the why and the kind of the goal of bringing something like this in. It opened the floor for the clinicians to really kind of drive the use a little bit and to feel like they were championing something. I think that as we look at this at a bigger scale, that involvement piece may be a little bit less because it's not a pilot. But it's the kind of the discussion about how it's been implemented, what we've seen in other places. As far as when we roll it out to other clinics. And I think that ties into the second part of the question about outcomes from the adoption. And I think what we're seeing is that, again, people feel confident about a decision not to prescribe. I think a lot of times, there's that hesitancy, there's that, am I going to get pushback from my patient on whether I still need an antibiotic or not. And sometimes that may be mitigated through wait and see antibiotic prescribing and things along those lines. What we've seen with this is the clinician has the confidence to go in and say, look, this isn't a bacterial infection. We've got that initial FebriDx that helped us to determine that along with the clinical scenario and any additional testing. And we can feel confident that this is the road we should go down. And so we've seen that prescribing rate come down because of that. And the patient satisfaction side of it has actually been impeded. Like we've not seen a change there at all with the great NPS scores that we see in that clinic. And on the patient side, where a lot of people now, I mean, I think 5, 10, 15 years ago, there was a lot more -- we always expect an antibiotic, and that's true. That's still there. There's also the group that's like, I don't want an antibiotic to know that it's necessary. And so being able to tell somebody, hey we have this result that says it is bacterial and you do need the antibiotic can be sometimes just as important as being able to say this isn't bacterial and you don't need the antibiotic. So I think that confidence has been a real big boost for our clinicians, and it's probably been a big piece of why the adoption has been as smooth as it has.

I have another question for you. This is a great one. In your urgent care sensor is the triage done by the clinician seeing the patient or with a nurse or medical assistant who is the first person to see the patient?

Yes. And that's I know from the way I presented that it might have seemed a little confusing. I mean the medical assistant is absolutely the first person doing the intake. During the pilot period, we would involve the clinician once somebody was identified to have respiratory symptoms that would fit the scope for FebriDx. Just so that we could determine whether it was appropriate to use it, make sure the clinicians felt comfortable out of the gate. And I think that does, again, going back to the first question, help with the adoption a little bit early on because the clinicians were involved. But what quickly the feedback we got was, look, this is great now that we understand how this test works, we really want that to be part of this kind of workflow where the [ MAAs ] has the standing order ability to go ahead and order that under certain circumstances. That being said, there's going to still be times where a test doesn't fit into a standing order protocol, and you don't feel comfortable having your MA going ahead and running it. But you would still be able to add it on it because it's such a fast test, it really still doesn't impede the clinic workflow and the pace that the clinicians...

Thank you, Dr. Bobb. Appreciate that. The next question that we have is, can you explain your clinical thinking on using the FebriDx test before you do a COVID/flu tests.

Yes. I think, again, there may be circumstances where COVID or flu is tie in the community and you might change your guidance, but there's always that question that patients are going to have about bacterial or not. There's also the question that arises, even though it's unlikely of co-infection. And so I think this is another tool there. I mean, rarely is that going to be the issue for the patient, but it does give you another piece of information there. I feel like having that bacterial nonbacterial kind of determination early on has really helped us to narrow down the pathway a bit. Again, if what you're seeing is all flu, you may make a choice to use it differently in your clinic. But when you have that negative or that in determinant, and you're seeing somebody in front of you that has symptoms, and they're going to want to know, okay, well, you're telling me it's not flu, everyone else has flu. So then what is it? That's where you still may want to use the test. So I think that there are different ways to apply it. Again, when we started the pilot on this, it was before the flu season was in full swing. And so we were seeing more of a mix of different respiratory viruses along with the bacteria components and having that flexibility of having a bacterial vs nonbacterial versus nonbacterial track was very important.

Thank you, Dr. Bobb. That brings us to our next question for, Annie. Could CRP inflammation be elevated due to other chronic or comorbid conditions and therefore, cause a false positive result.

Sure. So that's a great question. So the CRP, so many people can have an elevated CRP due to other comorbid conditions or underlying information or procedures that they've had, injuries that they've had. However, it's typically below the level of detection on our test. So our test is designed with this in mind. And the level -- the limit of detection is around 20, whereas most underlying inflammation that is not due to bacterial infection would be below 10. And so the test is designed to exclude that noise and is only identifying information that is going to be elevated due to a likely due to an infection. That's how the test is intended to be utilized.

Thank you, Annie. What is the cost of this test?

It averages between $25 and $30 per test.

And what is the CPT code and reimbursement rate for FebriDx?