Quanterix Corporation (QTRX) Earnings Call Transcript & Summary

January 13, 2022

NASDAQ US Health Care Life Sciences Tools and Services conference_presentation 40 min

Earnings Call Speaker Segments

Tycho Peterson

analyst
#1

Good morning, everybody. Welcome to Day 4 of the health care conference. I'm Tycho Peterson from the life science team. It's my pleasure to introduce our next company this morning, Quanterix. Before I turn it over to Kevin, just a quick reminder. You can submit questions through the website. And with that, let me turn it over to Kevin.

E. Hrusovsky

executive
#2

Thanks very much, Tycho. I think this is the 20th time I've presented at JPMorgan, and I would encourage investors to look at the regulatory filings. We will be making some forward-looking statements. Now to start off in this conference, it's been incredible the number of meetings we've had over the last 4 days. And we've tried to incorporate some of the top questions that we were seeing from our investor base into this agenda. But starting off with our achievements in 2021. We have this symbiotic relationship between RUO research and diagnostics that spans across COVID and neuro, particularly Alzheimer's. And so we're going to talk about that Alzheimer's opportunity, describe our objectives, provide our investment thesis and then open it up for questions. So with that, I'd like to just start where we started in the past, that we have an ecosystem that's really trying to innovate what we would say is plasma biomarkers, starting with therapies first, helping therapies get approved. And then ultimately, we think prevention, these same biomarkers can play a major role and try to navigate disease triggers at a personal level. That's a long-term vision. Starting with neuro and COVID and then moving to cancer and then cardiac being the largest groups that we feel have the best potential. Quanterix is very linked to this ecosystem. We have a lot of partners. And interestingly, we've spent a lot of time with companies like Lilly. We have a lot of large pharma relationships, and those relationships are benefiting from the work we've done with COVID and the credibility in our EUAs with the FDA and the NIH and also with payers and our ability to begin to teach that you can see disease before symptoms noninvasively from home care. You've got a chance to really change outcomes significantly and more efficiently. So with that vision, basically, you've seen a lot of activity in the last 6 months around blood plasma markers and the role that they can play. And you see a lot of statements being made by a lot of companies. And we still believe that this is the first inning around using our exquisite sensitivity to explore how these biomarkers are relevant to the biology and clinical discrimination. And so early on, we showed a slide that said that we know that there's a lot of proteins that are being measured today in their concentrations quantitatively, but they're doing that at the tip of the iceberg. And our view has been that when you bring the detection levels down a thousandfold and maybe even 100,000 fold, you start to see a lot of other proteins, particularly in noninvasive fluids, that allowed you to see disease earlier less invasively. And this has been key to our overall strategy. We've shown this slide for the last 5 years that on the left axis is the invasiveness of the sample. The X-axis is when do you see the disease. And you can see some of the most lethal diseases. You don't see them until after symptoms present. And by the time they present, the disease is pretty lethal. So our view is that today's detection limits are preventing this real monumental change, which we believe is trying to shift down the invasiveness to blood, saliva and urine and also seeing disease before symptoms when that's much more treatable. And our goal is to move these 3, as we've stated, into the bottom left quadrant. Now there's a lot of new entrants into this proteomics field. We've been talking about this probably for about 7 years now. So I wanted to just give you an update in the way we're viewing the plexity and the TAMs 2025 and beyond. And you can see on the right-hand side here, when you go from discovery to research to drug trials and then ultimately to diagnostics, there's this category called translation, and that's where we're playing. And we're playing today with about 6-plex and less. And we believe that most of the TAM sits in that category because of the utility these technologies are bringing to drug trials. And then ultimately downstream, we think that you could shift the whole field from symptomatic detection, where today Roche, Abbott and Siemens are collecting a lot of data and given a lot of results with, I think, 212 single-plex assays, something like $25 billion in revenues being collected from those 3 companies on those assays, all single plex. And most of those are occurring after symptoms present. So our view is, is if you continue down and look at the cost, it's more expensive per test in the discovery end, but when you get into the higher-end diagnostics, you really have to create very low cost with high throughput. And that scalability is key to the Quanterix position. Where you could see Siemens, Roche and Abbott are playing on the right, Quanterix today is primarily in this translational portion. Our longer-term vision would be to keep expanding over into complete research, where we're talking 1- to 50-plex, and someday maybe even move further upstream. But down at the bottom, sensitivity is a thing that we brought to give us the low invasive, high level of early detection capability. And you can see the value propositions that this sensitivity is enabling us with a scalable technology. If you flip that around and take increasing plexing going the other direction, here's those 3 categories once again. And you can see some of the players that are in it and the different TAMs that we see evolving over the next 5 years. And Quanterix primarily today does sit in the center with a lot of partners to our left. We've been doing a lot of work out with those partners. And we are working to try to evolve our position, particularly in neuro, starting with Alzheimer's and MS and Parkinson's. But ultimately, we believe that the same philosophy, once the payers see this opportunity, they will be very supportive in moving into oncology and cardiology, where today we don't think pharma is as excited to work with us because our technologies could limit markets as opposed to expand them. But in neurology, when you're having trouble getting drugs approved, we're a very strong partner with pharma, and they're very supportive. So when we evolve this overall franchise of ours, we'd like to tell you the story many investors are asking. How did we get to where we are today? We started out in neuro, in research, trying to really showcase with a lot of third-party peer review publications the ability to see brain health in noninvasive blood samples. And we had a lot of breakthroughs in NfL for MS, and that was really a lot of our focus before COVID. COVID hits, the NIH approaches us, asks us to do RADx, we submit. We did $20 million last year to scale up an antigen test, and that really started to bring our infrastructure in place for diagnostics. And we did get a couple of EUAs, one for serology, and one for antigen. We recently got some advances even further on those. The NIH themselves, Tony Fauci's lab, is using our technology for actual drug trials on COVID agents. We also have at Emory a large installed base. Over 120,000 saliva samples for antigen have been run. So it's created the infrastructure and the credibility for us with the FDA. And they actually asked us, do we have anything for Alzheimer's? And we told them we have a marker that we think has got game-changing capability, pTau-181. -- We submitted that for breakthrough designation based on their interest in us doing that. And 55 days later, we were able to get this p-Tau 181 breakthrough designation, which now gives us, in the bottom right quadrant, an opportunity to either partner or to further advance our own position in the diagnostics in Alzheimer's, and we're working towards that. We still, though, believe we're a research-based company. Tycho, you taught me that early on. Stay in research as long as you can because there's no investment risks associated with reimbursement or regulatory approvals. And so we still believe a 30% to 40% CAGR from 2019 is very doable, and we had some incredible product growth this year, 84% in 2021. You can see in every category we were able to achieve our goals. So we continue to execute disruptive commercialization. And that's really the key here, is we're not just executing on something incremental, we're doing something very significant. And these publications are key, and there's now over 1,500 of them, another nearly 500 this past year, more than 1 a day. The instrument installed base, interestingly went up 32% this past year, exceeding our targets that we set for the early part of the year for HD-X. And we did migrate from SP-X given the advances that occurred in Alzheimer's with ADUHELM's approval and the donanemab's interest from Lilly on a lot of our workout. We did say at that moment we have a better opportunity and faster opportunity to support RUO trials in Alzheimer's. And so we took the foot off of the accelerator for cancer and oncology with SP-X and doubled down and created even faster growth using the HD-X in this way. Lilly and Biogen both have employed it. Biogen, after they got approval, employed it. I think they see it as a key potential opportunity for helping payers see the value of the technology and have a; low-cost, scalable way to move patients into the drug and then monitor the drug's performance so you do get evidence for coverage. We also strengthened our balance sheet, put another $287 million on it. We have over $400 million end of Q3. And we do see crossover in the RUO portion of our business, and we are growing significantly our revenues faster than our OpEx in RUO. We think this is important as there's somewhat of a pivot now from growth to value, and we want to continue to show that we have a very leverageable business. And we do continue to want to increase our sensitivity and see value for doing that. And so you can see the publications, the biomarkers and the number of instruments have continued to increase very methodically. And the number of customers, top 24 to top 25, are now using the technology either directly by the democratized instruments and consumables that we sell as well as our services from Accelerator. We did have 100% growth this year in our consumables. But it's somewhat of an off year in 2020. That's why we do a lot of comparisons to 2-year CAGRs. And right now, our 2-year CAGR overall is running at about 36% to 39% versus that goal of 30% to 40%. We are saying basically next year, we've got a lot of complexity as we try to execute moving into diagnostics, the early stages, as we try to form out our LDT lab and start evolving down that pathway. So our growth next year if we were able to hit 18% to 20%, we would still be in this 30% to 40% CAGR range. So have not guided other than the 5-year guidance, but our view right now is, is that most of our analysts and our investors have a pretty good lock on our growth and are staying conservative, which we would encourage as we now navigate into a whole new category, which could significantly fuel growth above those levels if we can break into the diagnostics, which, by the way, the more we do in diagnostics, the more interest we get in RUO because the pharma customers want to make sure there's a pathway to the clinic because getting payment for their drugs is key. So they want to make sure that these biomarkers, which could play a key role with the payers, is being used in their RUO trials. And so it's actually enhancing our RUO business by being in diagnostics. And then we already talked about the increase in the installed base of instruments. And this just shows you really the different components of our business. The lab services did grow greater than 60% last year. So we did say this year, it was going to be more of a flat year. We were going to force and spend a lot of our supply on instruments and consumables. We felt this was a key place for us to play. 2022, we'll start to pick up the lab services' revenue growth once again. But overall, this is a very good picture, a very strong 2021. We've talked a lot about being a superb executor and making sure we continue to deliver great results. And we're -- we feel there's not a lot of risks on the RUO side, and that's why we've got nice growth catalysts going into 2022 and the diagnostic drug trials as well as the way we're scaling our assays in our Accelerator team, where we actually can work directly with customers and create relationships that could lead even into a diagnostic relationship downstream. And then as we've always talked about, the aspiration, there's a lot more value to create as we get into diagnostics, but it's much more treacherous. And so we don't really want to talk about what we're going to do here. We only want to let you know once we've done it. But we are going to make smart investments to ensure that we are teaming up with pharma to get a lot better economics and faster speed based on their samples to try to move across into an LDT position and then the single-site IVD over the next 2 to 3 years. So we do see longer-term growth catalysts that are pretty damn exciting, that create a lot more value potential but have a little bit higher risk. Interesting, a lot of people have asked us why neurology, and I've kind of said because pharma really wants to work with us there. We're not limiting their markets because they're trying to get approvals. But there's also great spending patterns in neurology. If you look at NIH, they've gone from 5% to 10%. Even though NIH funds have gone up, the percent of those funds have now gone from 5% to 10% for neuro. And you can see the number of drug trials in neuro expanding as well. So we selected this. We feel like we've got somewhat of a first mover advantage in this area with the sensitivity, and we're trying to really deploy it. We have one small example here that we have been showing over the years, is that there's a significant increase in the probability the drug gets approved if they use biomarkers. But the TAMs are pretty small early on. And you could see with our biomarkers for Alzheimer's there are a lot of press, that you can see these elevation in markers 15 years before dementia. And that was kind of key with the FDA's guidance on precognitive impairment. Get a drug approved using biomarkers is now something that is possible. And so this clinical utility is key then as moving from the adoption to the utility is where we are with the 181. That's how we got the breakthrough status. 10% share in this area of neuro for Alzheimer's and RUO is a $50 million run rate opportunity. But then when you move to diagnostics, a 10% market share of what's possible there would be $1 billion. So that's why it's a 10x opportunity. And we've got a lot of new developments that are leading us into this category with a lot more credibility with our relationships. So I'll also keep pointing out there's a lot of new markers coming behind the current markers. We have work that we're doing with Lilly on pTau-217. There is a pTau-231. Each of them have different points that they tell you that you've got the Alzheimer's in that cognitive pathway. So a lot of it is before memory loss or before cognitive impairment. But when you start to add these together, you can get much better area under the curves if you build panels. And so longer term, we do see panels being key to the future of neurology, both on the RUO and diagnostics. We did launch a 4-plex last year, which has been very successful. Here's all the different markers now we can test in blood for brain health. We continue to build that out with the publications and building that credibility. Now we know a lot of our customers have their own antibodies like Lilly, like J&J. So many times through our Accelerator, we do a lot of custom projects with them. Many times then, we'll use those antibodies to scale our own launch of a commercial RUO product and then ultimately diagnostic. We actually think that a lot of their work over the years in applied research has fueled both diagnostics and pharmaceuticals. Pharmaceuticals, though, has 10x the valuation as diagnostics. And so we think as we look at our customers, some of them being in both fields of diagnostics and pharmaceuticals, that we see this merging of these two different categories because when you get to the brain, it's going to be all about when do you deploy the drug agent to determine its efficacy. And so we think there's a field of neurodiagnostic therapies that's beginning to shift some of the value from pharmas into diagnostics as you start to see these diseases asymptomatically and presymptomatically. We had a lot of questions around the Alzheimer trial status. There's 300 trials right now, and we're really only on 1 trial. So we still are very much in the first inning as we move into RUO Alzheimer's. And you can see on the left side all the different trials and the different phases. But what you see in the middle is that we've got less than 1% of our current position in Alzheimer's even though it's fairly disruptive. So we're just starting to enter. And on the right, you can see we've had a lot of growth in our neuro over the last 4 quarters, further demonstrating this pathway that we're using into RUO. Interestingly now, if you look at the diagnostics side, there's a lot of people out there with Alzheimer's. And it's projected to really ramp up as the world ages and the population of the world continues to increase. And these create TAMs that are just extraordinary. So if you could truly see inside the brain through blood like the cholesterol of the brain, you have an opportunity to really pioneer in an incredible TAM. And that's something that we're keeping our eye on, but we're staying very disciplined in our investments and looking at ways that we can team up with pharma to achieve this. Yesterday, there was this ruling and further advances in our mind the important role that biomarkers are going to play over the next 5 years to help payers, help CMS with the ability to know which patients are going to benefit from the drug and then how is that drug performing in a scalable, low-cost way through blood. We think this is an important area. So we did lay out in our last investor meeting, third quarter call, the 3 areas and ways we're going to try to enter diagnostics, initially with single plex, longer term with multiplex, and the amount of investment that we think it will take our key years that we want to be teaming up with pharma to try to cover a lot of this investment. And again, these numbers are so large. I think the opportunity sits in a way that we have to give this a shot. We really believe we have an opportunity to innovate in one of the most important therapy fields in the world. And we're going to start with the trials and then evolve over to the right through an LDT initially and then using our breakthrough designation for laboratory IVD, single site. And these are the dates by year-end. We believe we will be there trying to stay conservative. And then ultimately, we are looking at distributive IBD. And we can also use partners and M&A if we can't do it ourselves. We're trying to keep the value in Quanterix. We got the same founder that founded Illumina. A lot of their value has gone downstream to Exact Sciences, Foundation Medicine and others. We're trying to keep the value of the symbiotic combination of RUO and diagnostics, at least for neuro, inside, but we are definitely interested in partners, as you've seen our partnerships with Abbott and Siemens. And so just to say we haven't forgotten about MS and NfL, but the FDA has not been focused on this. So it's still just in our assets but not our current focus. I will say, in closing, that we do want to continue the payer relationships. We believe that they're the key to transformation because of the ability to pay for improved outcomes by seeing disease before symptoms. And so in the short term, we see some diseases that could benefit and -- the payer groups today for using biomarkers to see disease very early. And then longer term, we think that there are therapies teaming up with payers that could be found more efficiently as pharma and payers team up together for some new, innovative drug trials. Then ultimately, we think there are some disease areas where new biomarkers need to be discovered. And we think the payers have large memberships that could play a role in some long-term surveillance studies to achieve that. So in closing, our objectives for 2022 are to continue that 30% to 40% CAGR pathway. We did say that 18% to 20% growth in 2022 does in fact keep us in that game, and we are going to be trying to do some important investments for future growth, moving into diagnostics, hope that we're going to continue to fuel this -- both of these sectors with the way in which we manage a symbiotic relationship. We've already mentioned the LDT plans, start the Alzheimer clinical trial for pTau-181 in 2022, before year-end. Scale supply and RUO growth is key because we are growing very rapidly in the last 5 years, and we want to keep that growth and we are investing heavily in that scaling, and NIH's $20 million further help that scaling, expand the pharma relationships and strategy. We do think moving to 20-plex and less over the next couple of years will be important. We don't see going way upstream. There's great players in Olink and SomaLogic and Seer that are doing a nice job upstream. But we do think moving to 20-plex could further enhance our translation, and then continuing, as we mentioned, getting the 100x rolled out in the Accelerator. Longer, longer term, when you move from therapies, we do think there's a great opportunity for prevention with these same biomarkers. And that's our long-term vision, is to see a biomarker watch that really does allow you to navigate this. So from an investor thesis standpoint, in summary, we've got a market that we think we've got unrivaled sensitivity in an ecosystem with PPH to penetrate the relationships between the payers, FDA, NIH and the pharma and diagnostic companies. We've got a very methodical, proven market penetration strategy that we're very carefully deploying with execution. We think proteomics field has never been brighter, and it's evidenced by Illumina's moves in the last 1.5 years to start moving into protein, which we think is more phenotypic and it has significant untapped opportunity. But the validation was key for us in our execution. Top 19 to 20 pharma, over 1,000 drug trials now that have used our technology, over 1,500 pubs. We actually believe that this is a level of adoption and validation that is somewhat unprecedented. So the penetration for us, it's really all about democratizing, building scalable technologies that we can have a razor-razor blade. We've invested a lot to pull this off. It's not easy. And we do think keeping the risks low and solid returns in the RUO landscape is a smart investment backstop as we try to move into the diagnostic opportunity. And we do have a Board and a management team with an incredible track record. So with that, Tycho, I'll turn it over to you for some questions.

Tycho Peterson

analyst
#3

Thanks, Kevin. Great presentation. A lot of questions on the neuro opportunity. And maybe I'll just start with the NCD decision this week. How does the NCD for beta-amyloid drugs impact you guys? And given the increased need for clinical trials, is this a significant growth driver?

E. Hrusovsky

executive
#4

Yes, we actually think that the payers have incredible reasons to be questioning whether reducing brain plaque is going to lead to cognitive improvement. And if you look at cholesterol, they're paying $1 trillion for statins. There's still not a lot of evidence of cholesterol's benefit to heart health. If you look at the amount of money going into oncology for shrinking tumors without extending cancer patients' life expectancy, again there's a lot of money being spent on endpoints that may not really translate to outcomes. So I'm really encouraged with Lilly's data where they've been able to use the phosphorylated taus to link not only the correlation to PET scans but also to improving cognitive impairment or slowing it. And Biogen did a readout after they got approval. And they read out about 5 weeks ago, also bringing both of their trials to a place where they're able to show cognitive improvement with pTau-181. So I actually think that the payers are looking for a way to scale ways to know which patients will most benefit, low cost, scalable, get people and patients into the drug efficiently and then to be able to monitor whether there's actually improvement. If you can get to these correlations with cognitive improvement with the phosphorylated taus, our belief is that this could be a breakthrough. And we think pharma is behind us on this, and we think that the payers are behind us. So we look at the ruling being a very productive ruling for our plasma markers moving forward.

Tycho Peterson

analyst
#5

Is there a chance the final NCD could include anything on blood testing?

E. Hrusovsky

executive
#6

It's hard to say, Tycho. I -- my view on this is that -- I've been carefully talking to a lot of pharma in the last 48 hours. We have beta-amyloid 40/42 for instance. And everyone looks at the amyloid plaque in the brain and then say, well, wouldn't amyloid -- beta-amyloid be a better marker to be looking at in blood? But what we have found is, is that phosphorylated tau has better correlations. It stratifies out Lewy body's dementia as well as frontal temporal dementia, where beta-amyloid, it can -- those can elevate for a lot of different diseases. So it's not as specific as the phosphorylated taus. And our view here is, is that we might want to look at some panels that look at multiple markers. Maybe you put the beta-amyloid with the phosphorylated taus, maybe with the NfL as well in GFAP. But we actually think that the more that the payers start to understand and learn, I do think that they will evolve to a place where they will back it and put it in their guidance. But I don't see it happening in the short term. But I do think pharma, some of them are real leaders in this field. Lilly's particularly has been incredible in how they are really diving on this opportunity to -- and promise of blood markers showing brain health noninvasively in blood.

Tycho Peterson

analyst
#7

And do you think the FDA could want to accept plasma pTau-181 as a clinical endpoint? And if so, what does it need for that to happen?

E. Hrusovsky

executive
#8

I think that there's a lot of trial work that's challenging, Tycho. If you look at what the FDA did when Scott Gottlieb issued the original guidance for precognitive impairment biomarkers, the way it was written was you use an existing approved drug to basically retrospectively prove out that marker that show that in those retrospective samples, that, that market does, in fact, come down. Well, in MS, that was easy because there were 15 previous drugs that Novartis and others with our NfL were able to prove that. Alzheimer's doesn't have that approved drug. And so it's a little bit more challenging. And the gold standard is PET scan. And we know that the PET scan doesn't start depositing in the brain. We don't see those deposits with our blood markers for 10 years after the pathology probably starts. So there's points in there where you've got positive -- in the cerebral spinal fluid positive markers, but you don't have any brain deposit yet. And so we actually know that the gold standard is somewhat of an endpoint that's really at the end of the disease. And so how you compare yourself to an endpoint that might have some issues is never easy. And so I think that's going to take some time. We have to carefully unravel this. We don't want to get ahead of our skis here because this is incredible science and technology. But because the gold standard is probably fraught with a lot of specificity challenges -- and when do you start seeing the image on the early disease? Because the earlier you can see this disease, maybe the higher possibility the drug has of being efficacious and lower dose for better safety. So everything is pushing towards trying to get the drug in the body much earlier so it's lower dose, less side effects, higher efficacy. But to do that, you almost have to get before brain deposits. So I think it's going to take some time. But I think folks like Lilly and some of the really credible players out there are putting a lot of money into this belief system. And that's the way it starts. It's the way it starts for all blood tests initially.So I do think it's something the FDA has asked us for. I think there has been some concern that COVID could actually trigger early Alzheimer's, and I think the FDA has been amazing in proactively looking for opportunities to advance tools that can really help advance the field of Alzheimer's.

Tycho Peterson

analyst
#9

And the breakthrough designation for pTau-181 is for patient triaging. What does it take to expand the use case into screening, monitoring stand-alone diagnostics?

E. Hrusovsky

executive
#10

Yes, I think that there's a lot of trials from sometimes the patient advocacy groups that also have a lot of samples, talking to some investors. They've been our like #1 source of business development ideas. But looking at the way Natera has used academia for some sample sets, as an example, I think the key here is initially accepting that triaging is where you have the best chance to try to play against the gold standard productively. And then, once you got that established, start looking at the academic trials, the advocacy trials that are showing, when you use multiple markers, you can increase the area under the curve not only when you have dementia but even when it's before dementia. So the more markers that you put into a panel -- and then by the way, when I say more markers, I'm not talking a lot of markers. I think 5-plex or less is going to be sufficient to get the area under the curve above 90%. For when you have dementia, there's already evidence we can get potentially, in some of the publications, above 90% even before dementia. I think that data needs to follow. We don't want to get ahead of our skis. We want to triage and not let this science become runaway science. We want to stay credible. We want to stay conservative. But I think there's just a massive amount of value to add to society here because Alzheimer's is a big issue, and it affects trillions and trillions of dollars of people that don't make -- that don't get paid. Families are just devastated when someone shows up one day and says, hey, I lost my keys. Well, what's the first step with that? And then how does that start to implode on a family? So I think the NIH, the FDA, all of them, see that this is a disease that's really going to be serious for the world and society. And we're watching China very closely. 1/3 of the patients are in China. We're seeing significant movement and investment in that sector for Alzheimer's, which is also really encouraging. So I do think that this is something that is going to be on our screen for the next 10 years. So it's not just proteomics, it's neurology. And proteomics is what we're skating to trying to get there before the puck's there.

Tycho Peterson

analyst
#11

And you're targeting an LDT launch for Alzheimer's by 2023. What are the main hurdles to clear along the path? And could partnerships or M&A accelerate that launch time line?

E. Hrusovsky

executive
#12

Yes, we're looking at 2 off ramps for each of those 3 strategies, Tycho, one being M&A, second being partnerships. Partnerships, we love, but we don't want to give up too much of the value prematurely. So we're trying to be careful in sorting out, making sure that a partner is bringing more value or at least as much value as we're bringing. So I do think that we're at a place where we have an Accelerator lab, we've got CLIA status. We've got the beginnings of that infrastructure. We hired Masoud Toloue midyear. He was running all of diagnostics for PerkinElmer. He's an incredible executive. We've got Dawn Mattoon, who actually ran all product development for cell signaling and antibodies, now running that diagnostics business with Masoud. So we're beginning to build the infrastructure to kind of get at this opportunity. So LDT, we're picking a time line that most investors are saying, why is it going to take you that long? And I just want to stay conservative. You taught me that, Tycho, particularly in diagnostics. And so I think we want to run some validation trials as soon as we can. We'll tell everyone about it once we've done it. We're trying not to predict what we're going to do and get investors buying in prematurely. We think we've got an incredible opportunity. We want to keep it in control and not let the value get ahead of ourselves.

Tycho Peterson

analyst
#13

Maybe last one on Alzheimer's and then we'll move on. How do you think about the use of imaging going forward? Do you think it gets used in tandem? Or do you think the FDA neurologists might move away from imaging longer term?

E. Hrusovsky

executive
#14

I actually believe that imaging will be paramount initially because it plays such an important role as the gold standard and it's what most of the data sets are built on. And that's why it's faster for us to team up with pharma to get there, because they've got all this data and all these samples and all these retrospective datasets with PET scans. And that, with also CSF, that's invaluable to try to progress the field. But I do see that in some other areas at some point, blood testing can evolve to a place where it actually becomes bigger than the imaging. And I think the area of cancer is one we're all watching very closely. By the time you see a tumor, you've got over 1 billion cells that have agglomerated. And so the sensitivity of seeing cancers via imaging is probably pretty late. So it's probably no different in the brain. By the time you get brain deposits, it's pretty late. I think that the field of neuro therapeutics is all going to be about getting to these diseases at a moment when you can either prevent them or you can put very low-dose, low-toxicity agents into the body that's going to keep the progression from occurring. And I think once that occurs, the image may not be as important because it might be too late stage for it to be beneficial for that approach for deploying medicine. And that's where I think the payers are going to be key. They're going to teach everyone through the evidence whether or not these biomarkers can bring a whole different way of asymptomatic medicine versus today's reactive symptomatic medicine that really leads to a lot of the pain and suffering and expense because it's so late in the pathology.

Tycho Peterson

analyst
#15

Yes. Actually, I have one more that came in on email on this topic. As Lilly launches a pTau test, how does that impact you guys?

E. Hrusovsky

executive
#16

Well, it could be a great thing because they like us and we like them and they love our technology. And we did comment after they did a press release in Q3 that they did buy a lot more of the HD-Xs, and we're working very closely with them. We've got nothing but admiration for Dan and Mark Mintun and David Ricks and the way that they're conducting the process. This is obviously game-changing science that we're attempting to do here. So I think that there's a good chance that they would want to work with us. But I would ask you to talk with them about that.

Tycho Peterson

analyst
#17

You mentioned the COVID-Alzheimer's Link, which is an interesting one. I know the FDA is looking at COVID and -- long-haul COVID and the link to a decline in IQ, kind of like lead poisoning. Can you maybe just talk about some of the COVID-related work that you're seeing?

E. Hrusovsky

executive
#18

Yes, we never wanted to do anything in COVID that started to look like we were being commercially trying to win at COVID. We wanted to help the country and the world and do whatever our duty was. So when we got into this initially, we were basically responding to NIH asking us to submit for RADx because they thought we could see COVID before symptoms. Well, we did do that, and what we ended up finding is we can see COVID long before symptoms, but we can also see it in blood. So Tony Fauci and his lab airfreighted down a lot of our systems to Bethesda, Maryland. And so a lot of the monoclonal antibody trials as well as remdesivir analogue trials are being done using our technology with the NIH for measuring the antigen in blood. So it becomes a much better endpoint than how many days is someone in the hospital. So this is turning the COVID long haul or opportunity into more science with these biomarkers that have the sensitivity. So we're very encouraged by the work that NIH is doing. And they also are talking about utilizing us as a gold standard for antigen tests because of our sensitivity and specificity. But I would also say that the saliva work that we've done with Emory has been pretty exciting as well in COVID. And they are a research institution. And that's why we liked to place all those instruments with them, because they're looking to pivot into long-term investigations of infectious disease. So we actually think that's was an opening for us to get into infectious disease through COVID at some select centers that also have a lot of neuro. Emory has got a very large neuro, and they got our instrumentation there for neuro. So that linkage between infectious disease and neuro, we think, is -- always has played a role. There's always, in many viruses, been linkages to CNS. And so loss of taste, smell and brain fog are those trigger points that they're interested to try to understand. And so I do think that it's opened up us to becoming a very different company with the credibility that the NIH and FDA have put on us with these biomarkers. So I'm encouraged by the COVID work. I don't see us being lapped with like revenue implications. It's a small position. We've tried to do whatever we can to be complement where people can't. There's a lot of testing already successful. We don't want to just go in there commercially. So that's the way we're positioned, Tycho.

Tycho Peterson

analyst
#19

Great. Well, I think we're going to leave it at that. We ran a minute over. So Kevin, great to see you. Great presentation. And we'll talk to you soon.

E. Hrusovsky

executive
#20

Thanks so much, Tycho. Always a pleasure to work with you, man. Take care.

Tycho Peterson

analyst
#21

Okay.

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