Quanterix Corporation

everyone, and thanks for joining us today. With me on today's call is Masoud Toulou, President and CEO of Quantarix. Before we begin, I'd like to remind you about a few things. The call will be recorded and will be available on the Investor Resources section of our website. Today's call will contain forward-looking statements that are based on management's beliefs and assumptions and on information available as of the date of this call. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, assumptions, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. The risks and uncertainties that we face are described in our most recent filing with the Securities and Exchange Commission. With that, I will turn the call over to Masoud.

Thanks, Mike, and good morning. Before we start, I'd like to thank Kevin and the board for their support in this new chapter at Quanterix. Kevin's dedication and passion for this company and its impact on healthcare goals are shared, and I look forward to working with him, the board, our employees, and customers. You know, since I joined Quanterix last year and transitioned to this new role two weeks ago, What has been very clear to me is that our ultra sensitive single molecule array, Samoa, technology is being used every day to see, detect, and measure proteins in a way that's unparalleled. But it's how we effectively deploy this technology that counts. This includes unlocking new biomarkers, playing a key role in breakthrough research, and ultimately developing tests that will have a significant impact on the human condition. Last quarter, we reported total revenues of $29.6 million, which represents a 9% growth year over year. And as previously stated, we're on track to achieve revenues between $122 and $134 million, with higher growth rates on the back half of the year. Our growth was driven by strong performance in our consumable segment, which grew 28% year over year. Excluding our 22 Lilly collaboration, that growth was partially offset by instrument and accelerator decline, driven by strong demand in 2021 for pandemic testing in our laboratories. We realized the benefits of our collaboration with Eli Lilly which is a partnership that Quanterix has been working towards for several years and provided $2.7 million in revenue during the quarter. As a reminder, this multifaceted agreement provides Quanterix access to Lilly's PTAO 217 antibody technology from year-term Samoa-based research products and services and future in vitro diagnostic applications. It also establishes a framework for collaboration that we expect will drive continued growth as well as revolutionize the diagnosis and treatment of Alzheimer's disease. Our adjusted gross margin of 49.3 declined by approximately 1,000 basis points compared to last year. As part of our transformation and scale with quality focus, we are implementing several new processes, one of which is around inventory management. which did have an impact on margins this quarter. These new process changes will be an important foundation for future performance. Operating expenses were approximately $32.7 million compared to $26.1 million in Q1-21 due to personnel increases and lab expansion to take on several new projects. In terms of cash, we spent approximately $22.1 million to support our operations and additional factors that Mike will discuss. Looking at our revenue growth by geography, we continue to have very strong presence in North America, where we grew 18%. Our year-over-year growth in Asia was driven primarily by lack of activity in 21 due to COVID, and a reduction in the EU was due to strong prior COVID-related demands for pandemic testing in our labs. We maintained a roughly even split between revenue earned from pharma, CRO clients, and academic clients during the first quarter. Publication pull-through continues to grow. Our Samoa technology was highlighted in a record 151 new publications in the first quarter of 22, bringing total Samoa-specific inclusions to over 1,700 since its inception in 2006. Eighty-two percent of our first quarter revenue stemmed from neuro-related offerings, up 77 percent compared to prior year period, driven by strong adoption of Quantirix's neurocapabilities, strong demand for our PTAL181, and neuromultiplex assays. Now, I'd love to spend some time highlighting a few of our exciting operational and business developments that we announced this quarter. starting with receipt of our breakthrough designation from the FDA for our Samoa Neurofilament Light Chain, or NFL plasma test, which followed our announcement last year for the same designation on our PTAL 181 test. Using our technology, researchers from Basel were able to quantitatively measure NFL in human serum and plasma, which when used in conjunction with clinical imaging, helped to identify relapsing-remitting multiple sclerosis patients who are at risk at low or higher risk for relapse within four years. This could therefore be useful in tailoring the therapeutic approach to more effectively treat the disease. If approved, the Samoa NFL test could help the MS community by offering a more effective detection method. You know, it's really important to achieve this, but I want to caution that developing these IBD tests takes time, and we don't expect any near-term revenue impacts from regulated products. One of the limitations of the NFL biomarker test was establishing a baseline that corrected for age and body mass. As people age, their NFL levels increase. This study looked at over 10,000 samples from over 5,000 subjects to establish a baseline and give us a better understanding of NFL in identifying individuals with brain health concerns. The database established by this study was published in The Lancet and is an important milestone for our Samoa NFL test. Quanterix's Samoa technology also enabled the completion of multiple other high-profile studies, the results of which were published during the quarter. Through a recent study from the Harvard School of Public Health, Samoa technology was instrumental in detecting NFL protein at ultra-level levels to reveal a high prevalence of Epstein-Barr virus associated with MS. This evidence suggests that EBV is the leading cause of MS, a truly revolutionary finding for the entire MS community. We're thrilled Samoa was a key part of this discovery. Now, I'm going to turn it over to Mike to discuss some more financial details. Mike?

Thanks, Masoud. I'm going to provide some additional financial details about our first quarter 2022 performance. And for your reference, for those following on the call, it will be slide number eight. As Massoud noted, our total revenue in the first quarter of 2022 was $29.6 million, a 9% increase versus the first quarter of 2021 revenue, which included approximately $2.3 million of revenue from our non-recurring and now completed RADx awards. We had product revenue in the first quarter of $20.7 million, an increase of 13% versus the first quarter of 2021. Within product revenue, consumer revenue once again had solid growth, increasing 28% in the first quarter versus the prior year, driven by our strong demand for PTAL 181 and our neuromultiflex assays. First quarter 2022 service revenue increased 37% versus the prior year first quarter to $8.8 million. Included within services revenue is $2.7 million recognized during the first quarter of 2022, from our collaboration with Eli Lilly announced during our Q4 2021 release. We feel comfortable the customer's activity has returned to pre-COVID levels. However, potential spread of new variants could force renewed lockdowns. In addition, global uncertainty with rising inflation and the war in Ukraine continues to have the potential to impact our performance. Our Q1 2022 gross margin was 49.3%. compared to 60.1 percent in the first quarter of 2021. There are a few factors that drove this change. Our recent growth has highlighted inefficiencies in our inventory management processes. In response, we made a change in the way we estimate and reserve for excess and obsolete product. This change looks at 12 months activity versus three months and should result in a more accurate assessment of the NO reserves. The initial impact of this change materially affected our results for this quarter. Due to higher inventory balances, we also instituted a longer early quarter shutdown in Q1 of 2022 as compared to Q1 of 2021 to perform our annual physical inventory count, which impacted productivity. We've made a number of process changes to how we manage inventory that will allow us to scale with quality and improve margins going forward. Our operating expenses totaled $32.7 million in the first quarter of 2022, an increase of $6.6 million versus operating expenses in the first quarter of 2021. Major expense drivers were volume-related activity, personnel increases, outside services, and laboratory expansion as we scale the organization and invest in process improvements. During the first quarter of 2022, our cash balance decreased by $22.1 million, Ending unrestricted cash balance was $374.3 million at March 31, 2022, and basic weighted average shares outstanding for EPS totaled $36.9 million for the first quarter 2022 period. Cash outflow from operations was $22.1 million driven by higher operating expenses, primarily driven by headcount increases, timing of vendor payments, and capex. With $10 per share in cash and no debt, our balance sheet is in excellent shape and we're well positioned with adequate resources to pursue our strategic objectives. Overall, we're pleased with the first quarter performance and the progress made on our strategic priorities and remain committed to delivering solid remainder of the year 2022 results in line with expectations. With that, I'll turn it back to Massoud.

Thanks, Mike. Now, before we open up the line for questions, I want to recap where Quantarix is today and talk about where I see the company headed in the future. Looking ahead to the rest of fiscal 22, we want to be clear that we're focused on three primary areas, starting with scale with quality. As we enter our new chapter and realize the full potential of our platform, we're keenly focused on scaling our products and services to meet increasing demand. I want to send a message out there that we want the best operations people and scientists to join an existing group of extraordinarily talented individuals. And organizing around these incredible people and executing our new model are going to be critical for us. Second, in the biomarker space, it's clear that we're on the front lines of innovation. Key drivers behind this innovation are our people, the feedback we receive through our deep relationships with customers and researchers. Quanterix is rooted in a deep heritage of scientific breakthrough, and we believe it's early innings for us. We announced the release of our 100x sensitivity in our accelerator by the end of this year, and we expect to provide, for the first time, PTAU217 on the Samoa platform in the same timeframe. We'll pursue both organic and inorganic investments as we enter this new chapter. Finally, we're focusing on the translation of research biomarkers to those that are being used in clinical testing and ultimately diagnostics. We're validating both PTAL181 and NFL in our CLIA lab and look forward to making these tests available in the near future. Samoa is uniquely positioned to detect biomarkers early and plays a differentiated role in this continuum. Let's open up the lines for questions. Operator?

Thank you. As a reminder, to ask a question, you will need to press the star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Max Masucci of Cowan & Company. Please proceed.

Hi. Thanks for taking the questions. You know, first one, last week, the FDA approved the first IVD test used to aid in the detection of Alzheimer's disease. It's a CSF-based test that earned approval through the Breakthrough Device Designation Pathway. So, Masoud, it would be great to hear your thoughts on the CSF-based test approval, whether you've had any recent dialogue with the FDA related to your two breakthrough device designations for PTAL 181 and serum neurofilament light, and whether you'd expect a similar timeline in terms of how quickly your two tests could advance through the breakthrough device designation pathway.

Hey, Max. Thanks for the question. So the way we look at this is that on our breakthrough designation on the NFL test, we just received that this quarter in Q1. And I'm very excited about that and being able to measure NFL and what it's going to do for relapsing, remitting MS patients. We heard about the test, the CSF test. You know, obviously we had the 181 breakthrough designation in last year for Alzheimer's. And, you know, I think when you look at measuring whether it's a 181 or NFL, the best screen is probably going to be ultimately in blood. And so, you know, CSF is great for us because it now serves as a a marker that we can measure to as opposed to a PET. So we're very happy that that, you know, was approved. But we think that, you know, the plasma blood screen will be the final ultimate perfect screen for the market.

Okay, great. Masoud, can you give us any sense for, you know, how your conversations and interactions, you know, with Alzheimer's drug developers are and regulatory authorities have changed in the past month since the final NCD. For beta amyloid antibodies, it's been about a month now, and just if you've seen any changes in the behavior in your customer base over the past month.

I think that obviously the NCD came out, and there's a lot more interest now to do more testing and more trials with our 181, our 217, and a lot of the other antibodies, A-beta, 40, 42. And clearly, there's a few other shots on goal for Alzheimer's with a few other pharma companies. What is consistent is that some more work has to be done in the field, and when those people are doing that work, they're using our tools and our technology. So, you know, it's been positive for us. A lot more interest in doing more testing and examination of different types of biomarkers. From a regulatory standpoint, you know, we don't see any major difference here. We talk about our, you know, our single site IVD breakthrough designations with the FDA. At the same time, we also announced at the beginning of this year that we're also looking at some LDTs to our CLIA laboratory. And so that as a first step, and then the single site IVD as a second step in the future.

Great. Final quick one for Mike. We've seen a number of companies in our coverage chart out their path to profitability. It would just be great to get a sense for how you're thinking about the revenue level that would be required for Quantarix to cross over. into cash flow breakeven or any other details around how you're thinking about the path to profitability?

Great question, Max. Thanks. And, you know, while we haven't, we've talked about seeing on our RUO business cash flow breakeven in Q4 of 23, early 24. And, you know, we haven't changed our posture there. We didn't assign a revenue number, but I think, you know, from our perspective, our goal continues to be to maintain our revenues and get our revenues at historical levels of 30 to 40% growth. That's obviously not the guidance that we gave this year, but I think we're looking to come out of this year and accelerate into 23, getting ourselves back into that range. So that's how we're thinking about it. And I will probably at some point provide more color and detail on that in a future call.

Great. Thanks for taking the questions.

Thanks, Max. Thanks, Max.

Thank you. Our next question comes from Kyle Mixon of Canaccord. Please proceed.

Thanks. Hey, Ms. Hood and Mike. Thanks for the questions. I wanted to start with the financials. So on the soft gross margin, you know, recognizing that 49% is not, you know, is not well below, like, what I would think quantarics kind of could be in the near term, maybe like a mid-50s, high-50s kind of business. But I just want to understand if there's any kind of number one supply chain issues. I heard, Mike, your kind of explanation there in the remarks, but just, you know, obviously supply chain is pretty topical. I just want to understand that. And then the accelerated gross margin dynamics. I mean, what could margins be a scale for that business versus maybe typical consumables? I know, I think it's stronger, I believe, but Louie was in there, of course. So I'm just curious about that. And then maybe Mike or Masu, can you just comment on like next quarter? You know, how should we kind of think about this going forward in the near term for gross margins? Thanks.

Yep. Hey, Kyle. Thanks for the question. I'll start, and then I'll have Mike chime in on your second part of the question. So I think the key thing for us, Kyle, is that we're trying to scale with quality and trying to organize our ability to deliver products to customers. And as we do that, we mentioned some specific changes to the way we do our inventory quality process. the way, you know, our mix changes as we get new demand from our customers. So, you know, part of that was a gross margin effect that we view as a low point, but we see, you know, us improving that gross margin with a lot of these process initiatives that we plan on implementing.

Yeah, to pick up on the quarter... A couple of things happened. I mean, we mentioned that, you know, as Massoud discussed, you know, our focus of scaling with quality, and I think we've taken a hard look and we're doing different things now in terms of how we manage our inventory. You know, what that impact was in the quarter was we basically, you know, we drove up the excess and obsolete. We had to record a larger charge there. And then we changed our methodology and our change in estimate in terms of how we look at the reserve in a go-forward basis that we think is reflecting what's going on. So when you make that initial change, which effectively was instead of a look back at three months' worth of history, it's a look back at 12 months' worth of history, that initial change has you bump up your reserve. So I think that's something that occurred in quarter that that's not going to repeat itself. But to Massoud's point, our focus is on really – really finding ways to scale very effectively with quality. I agree with your assessment that this is, you know, this is a mid-50s margin business, and that's what we're, you know, going to march our way back towards. Perfect. And with regard to accelerator, yeah, obviously we have, you know, Lilly running through there, and that's, you know, the beauty of that arrangement is, you know, we're really beginning to leverage our accelerator labs. And as a result, you know, we should start seeing margins that are meaningfully different year over year versus last year as the year progresses. We haven't put a stated margin goal out there for Accelerator. But, you know, it's, as we've said before, I think our consumables business is our highest margin. But Accelerator at scale should, you know, should approach that over time.

That was great. Thanks so much for that. And just looking at, like, red meat stratification by, you know, disease type or, I guess, application, oncology applications grew 31% year over year. Last quarter, that was flat. I know this includes, you know, immunology inflammation, but could you guys just walk through, like, what's driving the growth and if it's sustainable? Because it's obviously exciting given, you know, neurology clearly remains strong, but oncology is an interesting application for you guys.

Yeah, thanks, Kyle. You know, I think from a high... macro view, obviously neurology was a big pickup for us as well. On the neurology side, we see a lot of increasing demand from our customers. On the oncology side, there were a few publications, key publications that came out, mainly, as you said, on the immunology side, and that continues to be an area that's growing, especially from the academic standpoint. So, you know, I would say probably our biggest impact, though, has been on neurology. Okay.

Actually, on that note, so you received funding from the Alzheimer's Drug Discovery Foundation to accelerate this multi-analyte test. I'm just wondering, you know, it's incremental to your other tests that you've mentioned for Alzheimer's and other diseases. What's kind of like the end game, and how many, like, shots on goal do you want to really have here with this type of a test, and what's the kind of you know, path forward with this in particular? Obviously, it was interesting. I just wanted to kind of ask about that.

Yep. Yeah. Hey, Kyle. The way we, you know, look at this market, everything you've seen up to us, you know, up until now on the FDA filings or even what we've mentioned as an LDT, those are all single analyte tests. And, you know, we think they're going to be very important in triaging and screening. Okay. And then when you start to look towards, hey, what's a test that's going to be able to replace in the future imaging or supplant more invasive method, we think that's going to be a multi-analyte test that's anywhere between three and four or five analytes. And so with this funding and this collaboration that we're doing with VUMC, we're going to be developing an algorithm along with those multi-analytes for a test, a diagnostic test that actually replaces some of these more invasive methods. So that's the basic idea. So it's a little bit different from what we're offering today or what we've announced.

All right, great. If I could just ask a final question, you know, great to see the guidance being reaffirmed today, but clearly it kind of implies, you know, an acceleration in the second half of the year or at least kind of going forward beginning of the second quarter. Could you guys talk about what's going to drive that, you know, second half performance? Is there any kind of, you know, pharma contribution baked in there or something like that? I'm just curious about that.

Yeah, I'll take that. And then Mike might have some additional color. Yeah, you know, our view is that, you know, it's definitely back end loaded for in terms of our revenue. If you look at, you know, how we performed this quarter and we maintain on track until the end of the year. And I think you hit it on the head. It's exactly our pharma partnerships, collaborations. A big part of that, obviously, is the big announcement with Lilly, and then follow-ons from Lilly, the ability to offer new antibodies on the neuro side, and this being a very active area of research, testing, clinical testing in neurology, is really going to drive that back half.

And I think the only other comment I would add, Kyle, I mean, I think we said even on a fourth quarter call, you know, we had a lot going on that we were going to start the year with that both, you know, with new chief commercial officer, he's adding to his team. All of those things are going to benefit us in the second half as people ramp. And as we stay focused on, you know, resolving some of these other processes that enables us to To scale equality, you know, that's the busy part of our first part of the year, and I think as we get a lot of that behind us, you're going to see our ability to accelerate improve in the second half. All right, great.

Thanks so much, guys.

Thanks, Kyle. Thanks, Kyle.

Thank you. As a reminder, to ask a question, you need to press the star 1 on your telephone. And to withdraw your question, press the pound key. Our next question comes from Matt Sykes of Goldman Sachs. Please proceed.

Hi, good morning. Thanks for the questions, Sue and Mike. Maybe I could just start out with on the OPEX side. You guys, I think it was the third quarter of last year, you talked about increasing OPEX growth this year. Are you still kind of in line with where you see OPEX growth of the course this year? How should we think about the cadence in terms of OPEX as we move through 22 and maybe into 23?

I think we're in line. We're down a bit versus the fourth quarter. I think that Massoud has taken a hard look at where we sit right now. And I think from a resource standpoint, I think we're in a good place. I mean, we said we were going to staff to to begin to get our arms around all the opportunities we had in front of us. So I think from here on out, Matt, you know, you should see quarter over quarter probably a little bit more consistency. I don't expect that we're going to have a big jump up this year in OPEX.

Got it. Thank you for that. And then in terms of kind of segment revenues, I think you've talked in the past about this being, you know, probably a higher growth year for consumables and maybe accelerator revenues. less so for instruments. But as you think about maybe instruments versus consumables, how should we think about that mix in terms of growth over the course of the year?

Yeah, so I can take that on, Matt. So the view that we have is that obviously the instruments that we have in the field, they're increasing utilization. And as a result, we see that driving our consumable increase in the quarter. And We also are thinking of this as accelerator. You know, when we see a lot of demand in the field, the fastest way to get an answer on a biomarker is to send the sample or send the test to our accelerator. And so we see that, you know, growing in the year, especially towards the back half of 2022. So between consumables and accelerator, that's where we see a lot of attention. I think instruments, you know, can be a little bit quarterly, but that instrument drive, you know, is going to continue. But consumables and accelerator expect, you know, probably the strongest drivers in the quarter, in the year.

Yeah, and some color on instruments, Matt, because I know you focus on that. You know, our placement activity has been remarkably consistent in terms of what we add on a net basis. But what we saw this quarter was a higher mix of SRX versus HDX. So that impacts, you know, you have that revenue mix impact because the HDX obviously is our highest priced machine. So we had a little bit of a mix issue going on when you look at the activity in quarter. Even though our overall net placement was consistent with what it was in Q4, it's just more of a mix towards SRX.

Got it. Great. And then, Mike, just one last one for you. On this inventory management that you put in place in Q1, it sounds like the reserving and the processes you put in place is more of a one-time event in terms of Q1. We should expect gross margins to trend upwards, as you kind of talked about earlier in the call. But just to maybe help me understand about sort of the one-time nature of these process improvements, is it sort of isolated to Q1 and move forward, or should we be thinking about these types of adjustments as we move through the year? I just want to understand how that works.

Sure. It's a good question, Matt, because there's really two components to the process. our gross margin activity. One was just the amount of product that we obsoleted in quarter. And that is high. I think we've taken a strong look at what's going on there. So that was high. And then as a result of that and also as a result of our Q4 activity, we looked at our estimate for reserves and we changed how we looked at that. We basically went to a 12-month look back versus a three-month look back So the initial time when you do that and you're bumping up the reserve, which is what happened in quarter, that's more of a one time. But the other component of the activity, the actual obsolete product, that has the potential to be ongoing. Obviously, that's the focus that Masood is talking about is how do we manage inventory better in-house so that we don't have as high an obsolescence rate as we've had the last couple of quarters. So that could persist, but the actual adjustment to estimate is more one time. And then now it's just a matter of how we manage inventory going forward. So I think both Masuda and I believe that margins are going to improve from this point. That's what we're working towards. But could there be a bump or two? I don't know. I suspect there's always a possibility. But that's where we're managing to expanding the margins after this point. Got it. Thanks, Mike Masuda.

Appreciate it. Thanks, Matt. Thank you, Matt.

Thank you. Our next question comes from Puneet Suda of SVB Securities. Please proceed.

Yeah, hi, Ms. Uddin. Thanks for taking my question. So first one is maybe I missed this. Can you just elaborate a bit maybe at a high level first on HDX? Where are you seeing, you know, penetration for this product at this point in time? And who is, you know, who continues to ask for this product versus SRX? I think you pointed out SRX was more stronger in the quarter. So maybe just also help us understand the slower HDX in the quarter. Was that just largely inventory side of things or was there, or the input side of things, or was there something else going on there? And how should we think about a sort of, as we think about, you know, 2022 and maybe even to 2023, how should we think about the instrument placements? I mean, obviously, Quantarix had had strong placements before, but I mean, the story has evolved with more clinical trials. So, how should we think about, you know, the core business of instrument placements overall longer term as well? Thank you.

Hey, Puneet. So, you know, I think that the instrument story hasn't changed significantly. I mean, we're going to have some, you know, variation in the quarter. Obviously, our high-throughput customers use HDX, and that hasn't changed. That's still the preferred instrument for a high-throughput pharma or CRO customer, and the SRX is still more common in academia and lower-throughput users. So that hasn't changed. But what has changed, and it's an interesting view, is that as there's new breakthroughs, as we have access to new technology, we announced 217, how can you get your samples and tested with that biomarker as fast as possible, and that's through our accelerator laboratory. And so you see our accelerator growing faster this year based on some news in the market, some of the Alzheimer's drugs shots on goal that we expect to see over the next year, and just demand for some of the new biomarkers that we announced. So that's you know, a little bit of the mix shift towards accelerator and consumables, but no significant, you know, events or changes on our instrument. We expect that to continue.

Okay, that's great. And then on the product side, obviously, you came in software versus our expectations, and Maybe, can you help us understand, I mean, given the large NFL study that you had, a number of things where you're seeing momentum, obviously now as a result you're keeping your guide intact, which makes the second half a little bit more steeper than before. So maybe just help us understand, where do you expect to see the most momentum? maybe help us just, you know, sort of essentially describe a little bit more details on the guide itself so we can try to get comfort on which segments are going to, where we should see most acceleration versus others.

Yep, great. So, you know, the way, you know, we have this, you know, back-end increase, we think it's going to continue to be accelerator and our pharma customers. So whether it's our NFL test are 181 and even 217. We think that those are biomarkers that are highest demand, and that's where we expect a large pickup, a bigger pickup in Q3, Q4, while we keep the guidance intact. The NFL study that you mentioned was also very positive for us. NFL is one of our biggest selling biomarkers together, you know, combined with Samoa, we're able to get ultra sensitivity. And the key part about that study is that, you know, in the past, there wasn't really a normal serum NFL level, and that people's NFL levels, you know, as you age, and, you know, as your BMI is higher, those increase. So this study really established a baseline, and it examined a you know, over 10,000 samples, 5,000 subjects, and put together a normal range, a normative range. So that was not just critical for MS, but a database that, you know, is completely open to the public, and that makes NFL a more versatile tool for all types of research. So we were very excited about that. It was a very large study at Basel, and we think that this helps that biomarker and the you know, prognosis of disease activity. Okay.

And then this last one, are you seeing any changes on the competitive landscape overall with respect to Alzheimer's diagnostics? Obviously, this is an exciting field, so it seems that there is significant interest. So just wondering, given the capabilities you have, the 217, the NFL, other NFL being your own capability, I mean, just overall, Are you seeing sort of the changes in the competitive landscape? Obviously, it's good that you have breakthrough designation on some of these products, but just wanted to get a sense from you as to how you see the rest of the market is evolving around you.

Yep. So, you know, the one thing I would emphasize is that it's pretty hard to measure phosphorylated tau in blood at the sensitivity required for some of the, you know, precognitive disorders, including Alzheimer's. And, you know, you think about Quanterix's p-tau-181, for example. Our LOD for our 181 test is, you know, 0.03 picomoles per mil, and that's two orders of magnitude, you know, better analytical sensitivity than other PTAL tests out there. So I think that we have in two orders of magnitude delta between us and some of our competitors, especially around PTAL 181. And if you're going to test it in blood, that Quantirix is one of the more sensitive products in the market. So I think that remains. CSF, we obviously have tests for CSF. You know, CSF, you need less sensitivity and some good news, some positive news in the market around tests that the FDA has cleared for CSF measurement, which is more invasive. We're very excited about that news because that's also a good step in the direction for just research in general, and we can compare to more invasive tests. So overall, I think the dynamic is interesting. You see a lot of activity. We're excited to participate in it. Okay. Thanks, guys. Thanks, Vineet.

Thank you. I would now like to turn the conference back to Masood Talu for closing remarks.

So when I joined Quanterix, it was very simple. And I think for every employee joining, it's equally as simple. On average, every day, there are between one and two peer-reviewed research findings using our technology. And so even more simple than that is that Samoa is unlocking new discoveries every day. And this quarter, we talked about the linkage between Epstein-Barr and MS, which was a discovery that opens a doorway for more attention, focus, and intervention towards this debilitating disease. And as our customer demand increases for research like that, we need to make this technology more available. Technology like Samoa needs to get into more hands. And so one of our key areas of focus will be several changes in the organization that will ensure scale with quality. And this process begins with a new operational model, incredibly talented individuals, and a close connection to our user base. So it's early stages of this journey, and we look forward to providing you updates on our progress in subsequent calls.

This concludes today's conference call. Thank you for participating, and you may now disconnect.