Quanterix - Q3 2023
November 7, 2023
Transcript
Operator (participant)
Good day, and thank you for standing by. Welcome to the Quanterix Corporation Q3 2023 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Ed Joyce. Please go ahead.
Ed Joyce (VP of Investor Relations)
Thank you, Hope, and good morning. With me on today's call is Masoud Toloue, President and CEO of Quanterix, and Vandana Sriram, our Chief Financial Officer. Vandana joined us in August as Mike Doyle transitions into retirement in early 2024. Before we begin, I would like to remind you of a few things. The call will be recorded and a replay will be available on the Investor Resources section of our website. Today's call will contain forward-looking statements within the meaning of the US Private Securities Litigation Reform Act. These forward-looking statements 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, 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 filings with the Securities and Exchange Commission. To supplement the company's financial statements presented on a GAAP basis, the company has provided certain non-GAAP financial measures. Management uses these non-GAAP measures to evaluate operating performance in a manner that allows for meaningful period-to-period, period comparison and analysis of trends in its business. The company believes that such measures are important in comparing current results with other period results and are useful in assessing the company's operating performance.
The non-GAAP financial performance information presented here should be considered in conjunction with, and not as a substitute for, the financial information presented in accordance with GAAP. Investors are encouraged to review the reconciliation of these non-GAAP measures to their most directly comparable GAAP financial measures set forth in the appendix of the presentation posted to our website and in the earnings release issued today. I'll now turn the call over to Masoud. Thanks, Ed. Good morning, everyone, and thank you for joining us on our third quarter call. We're pleased to announce the six-quarter transformation plan we laid out last year is expected to be substantially complete by year-end, with assays rolling off our new scalable production platform in January.
Incremental improvements made throughout this year have been positively reflected in our financial results and continue to do so in the third quarter, with year-over-year revenue up 18% to $31.3 million, non-GAAP gross margin improving 1,300 basis points to 48.6%, and disciplined cash use going from over $17 million for the corresponding prior year period to under $2 million this quarter. On the foundation of this new ops platform, we will continue to improve gross margins and take our research business from one that's burning cash to one that's generating it. We'll deploy capital to, first, expand access to our platform, and second, enable patient testing with new biomarker solutions we've recently developed.
Simoa continues to be the leader in measuring proteins at the lowest detectable levels, and as we said at the beginning of this year, our goals are ubiquity, such that Simoa is not limited to just specialty labs, but accessible by all labs. This means additional biomarker diversity and instrument utility that ensures broad reach. We spoke a lot this year about improving operating scale and margins. In 2024, we're going to talk a lot about increasing innovation rate, a metric we're going to measure ourselves by. Last month, at the Clinical Trials on Alzheimer's Disease, CTAD meeting, Simoa-based blood biomarkers testing was revealed in several neuroclinical trials for monitoring, measuring efficacy of neurotherapies, and diagnostics. Simoa's ultrasensitive digital immunoassay technology delivers scaled, high-throughput measurement of neurodegenerative blood biomarkers, including those for Alzheimer's disease.
Of these presentations, Eli Lilly presented analytical validation and clinical performance of a p-tau 217 blood-based diagnostic test to identify amyloid PET positivity using the Simoa platform. Their study included over 1,000 samples and was run over multiple lots, operators, and Simoa instruments. The study demonstrated high correlation of p-tau 217 to amyloid PET, with an area under the curve of 91.6%. Simoa's ultrasensitivity translates to very low limit of quantitation necessary for blood biomarkers like p-tau 217. The VUmc Medical Center in Amsterdam presented phase 1 data highlighting the potential for differential diagnosis of Alzheimer's disease and dementia. Recall, we are working with the VUmc and ADDF on a clinical trial to support the diagnosis of Alzheimer's and determine, through a multimodal algorithm, threshold levels of key blood-based biomarkers to differentiate other forms of dementia, such as frontal lobe or Lewy bodies.
Early data suggests that the combination of p-tau and NfL measurements can aid in discerning frontotemporal dementia from Alzheimer's disease, with an area under the curve of 0.87. While there's much more work to be done in this study, including work at multi-center clinical trial sites, the early insights are promising. Reported in Nature Medicine in July, a 1,000+ participant study examined why certain amyloid-positive patients without cognitive impairment do not develop tau pathology. Our Simoa platform was used to look at astrocyte reactivity by measuring GFAP levels in blood. The study, led by researchers at the University of Pittsburgh, found astrocyte reactivity influenced Aβ effects on tau pathology in preclinical Alzheimer's disease. Now, these studies emphasize two critical points.
First, there's a lot more work left to be done with this terrible disease, and we believe we're entering a decade where significant effort and capital will be invested in research and clinical trials for Alzheimer's. Second, we're in the early innings of treatment, where there will be a focus on screening and diagnostics, expanding into prognosis and disease staging, both of which will require precise blood-based biomarkers at the highest levels of sensitivity. As an indication of the future, and based on what we're observing with the latest results, trials, and research, it will be multiple neuro blood biomarkers measured together that will tell the whole story.
Finally, I'm happy to report that a few weeks ago, we signed a new agreement with J&J Innovative Medicine and launched the LucentAD p-tau 217 blood-based biomarker test, combining Quanterix ultra-sensitive Simoa technology and J&J's p-tau 217 antibodies to provide high accuracy Alzheimer's disease testing. p-tau 217 levels can become elevated in very early stages of the Alzheimer's disease continuum, well before symptoms rise. Our p-tau 217 test achieved sensitivity, specificity, and an overall accuracy, each exceeding 90%, meeting the criteria outlined in the revised National Institute on Aging and Alzheimer's Association, NIA-AA, criteria for diagnosis and staging of the disease. These guidelines are important because the performance criteria for a diagnostic use case with a blood test was defined for the first time, with p-tau 217 being the only plasma biomarker appropriate for accurately diagnosing amyloid pathology.
Masoud Toloue (President and CEO)
This validates the use of fluid-based biomarkers and puts it on the same playing field as the historical standard of PET imaging. You know, we believe we're in a strong position to capitalize on these opportunities from supporting clinical trials to use in diagnosis. With the simplicity of our sample-to-answer system and the number of new biomarker discoveries happening on our platform, we're in a great position to maintain a long-term leadership role. Now, I'll turn the call over to Vandana to cover our financial results.
Vandana Sriram (CFO)
Thank you, Masoud. Good morning. First, let me start by saying that I'm thrilled to be part of the Quanterix team. It's a really exciting time to be here, and after a couple of months in the role, I'm even more impressed with our technology and its potential. Today, I'll take you through our third quarter results and an update on our guidance for 2023. Our total revenue for the third quarter 2023 was $31.3 million, an increase of 18% from the third quarter of 2022. Our instrument revenue was $3.7 million, a decline of 53% over the third quarter of 2022, and up slightly versus the prior quarter.
Consistent with prior quarters and in line with our peers, we continued to see CapEx constraints impacting the timing of instrument sales, a trend we expect will continue in the fourth quarter. Our consumables revenue increased to $16.2 million, or 63%, compared to third quarter of last year. This speaks to the strength of our installed base, as well as the improvements in our manufacturing processes as we were able to catch up with demand. Revenue from our accelerator lab was $6.2 million, more than double over the third quarter of 2022. Our accelerator services continue to be a valuable and differentiated offering and have been especially effective in providing customers an alternative to continue their projects in the current funding environment. Now, let's move on to gross margin for the quarter.
Our GAAP gross profit and margin was $17.8 million and 56.8% for the third quarter of 2023, compared to $10.9 million and 41.1% in the third quarter of 2022. Non-GAAP gross profit and margin was $15.2 million and 48.6% in the quarter, as compared to $9.3 million and 34.9% in the third quarter of last year. Our corporate transformation has enabled us to reduce inventory losses and drive efficiencies in our processes, and this is evident in our gross margin performance.... Our third quarter GAAP operating expenses were $31.6 million, compared to $47.5 million in the third quarter of 2022.
Excluding the impact of one-time impairment charges of $20.3 million in the third quarter of 2022, GAAP operating expenses increased 16%, and non-GAAP operating expenses were up 13%, primarily due to higher consulting fees and personnel costs. Our net loss declined from $35.1 million in the third quarter of 2022 to $7.8 million in the third quarter of 2023, due to improved margins from our redevelopment program, the absence of the impairments from 2022, as well as higher interest and other income. Moving on to liquidity, we ended the third quarter with $330.4 million in total cash and equivalents, a net usage of $1.9 million during the quarter, as compared to cash burn of $17.6 million in the third quarter of 2022.
Our efficiency gains have translated to significantly reduced year-over-year cash burn. Turning to guidance now for the fourth quarter and full year of 2023. As Masoud mentioned, we've made great progress with our redevelopment efforts and are in the last of the 6-quarter transformation process. For the fourth quarter, we will be focused on upgrades and readiness of our production lines as we introduce new assays in 2024 and in executing on the final steps of our transformation. With these objectives in mind, we expect our fourth quarter revenue to be between $27 million-$29 million. This increases our revenue guidance for the year to be in the range of $118 million-$120 million, compared to our previous range of $110 million-$116 million.
We are also increasing our gross margin expectations for the year and now anticipate GAAP gross margin percent to be in the high 50s and non-GAAP gross margin percent to be approximately 50%. As we implement the upgrades to our production processes, we expect non-GAAP gross margin to be in the mid-40s for the fourth quarter, slightly lower than past quarters, to account for potential higher costs from these transitional changes. Lastly, we now expect our cash usage for the full year to be in the range of $20-$25 million, an improvement from our prior estimate range of $30-$35 million. We expect higher cash outflow in the fourth quarter due to the timing of certain initiatives and payments. For the year, this reflects a significant improvement in cash burn over 2022.
Our increased guidance across all our key metrics reflects the continued strong demand for our Simoa technology and our execution against our transformation goals. Our balance sheet remains strong, and we are well positioned to support our growth and strategic initiatives. I will now turn it back over to Masoud before we take your questions. Masoud?
Masoud Toloue (President and CEO)
Thanks, Vandana. I want to copiously, you know, thank the entire Quanterix team for their hard work and focused effort. Dan, our COO, and Darren, our CCO, have been relentless in this pursuit, and as a result, you know, there's been remarkable progress in building a solid and scaled operations platform for our existing products and developing the engine for new product releases to come. If you can't tell, we're super excited about next year. Let's take some questions now.
Operator (participant)
Thank you. At this time, we will conduct a question-and-answer session. As a reminder, to ask a question, you will need to press star one one and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Kyle Mikson with Canaccord Genuity. Please go ahead.
Kyle Mikson (Equity Research Analyst covering Life Science Tools and Diagnostics)
Yeah. Hey, guys. Thanks for taking the questions. Congrats on the progress here. Just starting off with the new p-tau 217 agreement with Janssen, I had a few questions about that. First, Masoud, could you talk about deal economics? I think with Lilly, you know, a year and a half ago, that was about $11 million in accelerated revenue for, like, about a full year or so. Curious if there's a, you know, a comparison here. And then this agreement, like, was it brought on by any change in the relationship with Lilly? And does Lilly remain, you know, an important partner for you going forward? And then maybe just one clarification, will Lilly be using Simoa for its own Alzheimer's test because the company is working with other, like, analyzer and assay vendors as well?
I'm just, you know, get the question a lot about that. Thanks.
Masoud Toloue (President and CEO)
Yeah. Thanks, Kyle. Yeah, so to answer your first question, we haven't announced any sort of deal economics on the J&J agreement that we signed. However, you know, I would say that Quanterix expects the majority of the economics to come from, you know, our LDT and our kit sales and what we're doing with, you know, in the market and trying to get 217 into a lot of folks' hands. To your second question, I think it was on the broad use of 217. Our view, you know, on 217 is that we wanna try to get it into as many hands as possible. We think that, you know, we... Our collaboration with Lilly continues, and it's a very strong collaboration.
They presented, you know, some, you know, great data at CTAD on the Simoa platform, and so we expect that relationship to continue. And then, you know, on our LDT, it is using the J&J solution. But, you know, we want to make both solutions available to this market. And I think you had a third question. I might have missed it there, Kyle.
Kyle Mikson (Equity Research Analyst covering Life Science Tools and Diagnostics)
Just, yeah, and so far, so good. The, it was the, you know, is Lilly going— Lilly has its own Alzheimer's assay, right? Is that going to be based on Simoa or some other analyzer assay, you know, vendor?
Masoud Toloue (President and CEO)
Yeah. Yeah. So, you know, I think, it, you know, there was some clarity, you know, at the CTAD meeting. There was a strong analytical and early clinical validation of the Simoa platform in 217. And, you know, as I view this, is there's a lot of different types of solutions and platforms in the market for Alzheimer's detection. We're one of the more sensitive ones around 217, and, you know, I expect our efforts and collaboration to continue.
Kyle Mikson (Equity Research Analyst covering Life Science Tools and Diagnostics)
Okay, that was perfect. Thanks for that. And it was good to see the NIA-AA guidelines, you know, I guess, like, the new recommendations recently. Was curious how influential those are to clinicians in terms of going against the grain and kind of ordering with these novel products or like these tests that we're talking about here? And how could those guidelines, if finalized, impact CMS decisions regarding reimbursement as well? Like, is that a key question, you know, given this class of tests is still pretty early days?
Masoud Toloue (President and CEO)
Yeah. We agree with that, Kyle. I think it was nice to see the NIA-AA guidelines and criteria. You know, I think while it's not a direct clinical recommendation, I think it has a big influence and to your point could affect further decisions down the road. And I you know I really you know totally agree with what came out from the guidelines. One in terms of a blood test. If it's gonna be a blood test that's on the same playing field as PET, you know, 217 was a clear answer there, and we've been working on this, obviously, with our partners for years. And the data has been pretty strong through the clinical trials.
And then two, you know, if you look at the accuracy that's required in blood, it was high, and the sensitivity required is high. And so I, you know, applaud the organization for, you know, really picking a great test and great marker for diagnosis.
Kyle Mikson (Equity Research Analyst covering Life Science Tools and Diagnostics)
Perfect. One more before I hop off. The just on the P&L, and I guess as you kind of break out revenue, you know, you guys have a lot of one-time items. If you parse out those, you know, product revenue was a little bit softer than service. Service was quite strong. Product has the macro headwinds in there, but, you know, instruments declined a lot year-over-year this quarter, but it is down, I think, 37% year-to-date, so that's not just due to the recent CapEx constraints. Maybe, you know, I guess why—I mean, recognizing that overall revenue has been solid, and you have this program going, why has product revenue been relatively soft, and particularly instruments recently?
Then, for how much longer would you rely on kind of the service and accelerator revenue to drive growth?
Masoud Toloue (President and CEO)
Yeah. Maybe I'll start with that, and then, Vandana, if you have additional color. Well, first, I would say that we do think that, you know, some of the instrument softness, at least more recently, has been CapEx constrained, CapEx related. And that has transferred to our accelerator program, where people can do services. I'd say that what you saw this year with our redevelopment program was really building a platform. I think if you think back, Kyle, say, 4 or 5 quarters, when we announced the program and we built that quality wall, we added, you know, made sure things going out the door were going to be, you know, things that are gonna be scalable at the highest level of quality.
And so, you know, throughout the year, there's always going to be, there's always going to be a, a year of focus on our products and getting them, you know, at the highest level to customers. So some, you know, back and forth. But, overall, the consumables are going out the doors of our customers. The utility and usage on a per platform basis is good. And as you can see, you know, a lot of folks want to come and use our, our program, our accelerator program, to run these trials. So we don't see any softening on demand and desire using the Simoa platform, and nor do we see it in the area that we're in.
Vandana Sriram (CFO)
Yeah, I'd just add, you know, within product revenue, if you're combining instruments and consumables, consumables are actually up 63% year-over-year and up 7% sequentially. So we're very pleased with the momentum we're seeing on consumables. Some of this was a catch-up on demand as we streamlined our processes. Instruments, as you pointed out, you know, we continue to struggle with the overhang of the macro. We saw a little bit of sequential improvement this quarter. We were up about 5%, 1 extra instrument. But we do expect, you know, as this overhang on instruments continues, we do expect to continue to see volume come through the accelerator, which is helping to soften and balance that out for us.
Kyle Mikson (Equity Research Analyst covering Life Science Tools and Diagnostics)
Okay. Vandana, what was the catch-up for consumables? That was, like, super helpful. Just the catch-up is, if you can quantify that, you know, we're getting questions about that, too. Thanks.
Vandana Sriram (CFO)
Yeah, I'm not sure we can quantify it in dollar terms, but if you just look at our sequential improvement, you know, we were at about $15.2 last quarter. We went up about $1 million this quarter. All of these have a little bit of just catching up on pent-up demand. You know, our team is now at a point where we are mostly caught up with orders that we couldn't fulfill, and we're now kind of back on a steady state.
Kyle Mikson (Equity Research Analyst covering Life Science Tools and Diagnostics)
Awesome. Okay. Well, thanks a lot, guys. Appreciate the time.
Masoud Toloue (President and CEO)
Thanks, Kyle.
Operator (participant)
Thank you. One moment for our next question. Our next question comes from Matthew Sykes with Goldman Sachs. Please go ahead.
Jake Allen (Healthcare Equity Research Analyst)
Hi, this is Jake Allen on for Matt Sykes. Thank you for taking our questions. I'll ask both my questions up front. First, could you give us an update into the timing of FDA filing and approval for LucentAD and the IVD pathway for a broader menu of biomarker tests? And then additionally, how should we be thinking about the longer-term gross margin profile for the business, given the progress that you have made on margin expansion, which has trended ahead of expectations? Thank you.
Masoud Toloue (President and CEO)
Hey, Jake. So I'll take your first question. The FDA, I mean, we've, we've always said, you know, our strategy as an organization is to ensure that we're getting these tests out there as early and as fast as we can. And so that mechanism has been through our CLIA, CAP-certified laboratory here in Boston. And so that's, that's the start. We've also believed that these tests should, you know, also go through FDA approval, and our plan is to do that, you know, within the next several quarters and make sure we have a, a submission on our 217 to the FDA. And then, in terms of timing, you know, that can take some time, of course, depends on the agency.
But in the meantime, you know, we think getting testing done through the CAP CLIA lab is going to be important.
Vandana Sriram (CFO)
Yeah, and on gross margins, let me address near-term expectations, and then I'll talk a little bit about the longer term as well. Near term, I'd say our gross margin performance this quarter exceeded where we expected we would be. You know, we had signals to an early-mid 40s number for the quarter, and we did much better than that, partly because of volume, partly because of our improvements. We see a similar trend going into the fourth quarter, but we do expect some amount of margin headwind as we implement all of our production changes. Longer term, however, we've previously guided to wanting to accomplish margins in the 60s, you know, in the early 60s. We continue to work towards that.
There's obviously a lot of factors that will impact that, product mix being a significant part of that, as well as timing of how quickly some of our production processes start to spin out the new assays.
Jake Allen (Healthcare Equity Research Analyst)
Got it. Thank you, guys, and congrats on the continued progress.
Masoud Toloue (President and CEO)
Thanks, Jake.
Operator (participant)
Thank you. One moment for our next question. Our next question is from Dan Brennan with Cowen. Your line is now open.
Dan Brennan (Managing Director of Life Science and Diagnostic Tools Research)
Hey, good morning. Thank you for taking the questions. Maybe the first one, just on the guidance, just, you know, you've had some really good success here year to date. Just wondering, on the fourth quarter, implied guide, looks like, you know, kind of looks very conservative in light of kind of what you've done year to date compared to what you did in 2022. So I'm just wondering, can you give us a little color on, you know, how should we be thinking about that fourth quarter guide? And then, you know, if we cycle past the fourth quarter, are we still thinking double-digit growth expectation for 2024, or just any early read there?
Vandana Sriram (CFO)
Yeah, thanks for the question, Dan. So, you know, for the fourth quarter, as Masoud and I mentioned earlier, we are going to be hyper-focused on implementing the last stages of our transformation, standing up our second production line, and having assays on the shelf for 2024. So with that in mind, you know, that's going to impact the velocity at which our consumables go out. On the other hand, for instruments, you still have the macro overhang that others have talked about, which is unpredictable and, you know, hard for us to get good line of sight on. So keeping those in mind, also keeping in fact that the fourth quarter has less working days, which impacts the services businesses, we basically try to balance out our guide to a reasonable number.
With that said, you know, we continue to work towards the double-digit number for next year. As we get into the February quarter, we'll start to size that up more and define that a little bit more. But for now, you know, definitely expecting the fourth quarter to have some of these headwinds and planning for that.
Dan Brennan (Managing Director of Life Science and Diagnostic Tools Research)
Got it. And then maybe just one on kind of Alzheimer's. How should we be thinking about the sensitivity and specificity of a blood-based test as compared to PET, when we think about both rule out and rule in? And then B, how should we think about timing for Medicare coverage on, you know, kind of on the, you know, on the various kind of tests that you're, you know, looking to implement?
Masoud Toloue (President and CEO)
Yeah, Dan, so on the Alzheimer's side, you know what? I think, you know, what we saw in the guidelines, I would sort of direct folks to the NIA-AA guidelines. And there it was very clear, you know, that a test would need an accuracy that's above 90%. And when we did this, we did two studies. One was the Amsterdam Dementia cohort. Around 500 individuals were tested. And then we also looked at the BioHERMES trial, which was a multicenter site, 17 US clinical sites. And in both large studies, we were able to achieve accuracies that are above 90%, which is, you know, the guideline or the criterion in the draft NIA-AA. So very happy about that.
You know, I think that's going to be the case for any sort of test that wants to try to, you know, be on the same playing field as PET. And then your second question was on timing of reimbursement. Was that, was that the question?
Dan Brennan (Managing Director of Life Science and Diagnostic Tools Research)
Yeah. Yes, yes, it was on, it was on Medicare. How do we think the pathway forward for Medicare?
Masoud Toloue (President and CEO)
Yeah. So I, you know, I expect the Medicare path maybe initially will, you know, be laid out either by Local Coverage Determination or maybe in the next year or so as this becomes more and more important and in the hands of neurologists and people performing testing that it becomes potentially a, you know, NCD in the future. Hard, hard to say from timing perspective, but, you know, we hope that it gets the attention it deserves.
Dan Brennan (Managing Director of Life Science and Diagnostic Tools Research)
Great. Thank you, Masoud.
Masoud Toloue (President and CEO)
Thanks, Dan.
Operator (participant)
Thank you. One moment for our next question. Our next question comes from Puneet Souda with Leerink Partners. Your line is open.
Puneet Souda (Senior Managing Director of Life Science Tools and Diagnostics Research)
Hey, Masoud. Yeah, thanks for taking the question. So a first one maybe, and I don't know if this was covered, but, you know, there was a discussion of two-cut assay to drive a performance improvement at CTAD. Can you maybe just talk about that, if the p-tau assay is structured that way? And sort of what's the performance level that we should expect here? There was also quite a bit of discussion on, you know, the performance that would be needed to, you know, deliver on p-tau 217, where, obviously, Simoa has done well historically. So maybe can you just talk about, you know, how Simoa is positioned- products that are...
Masoud Toloue (President and CEO)
Hey, Puneet, can you hear me?
Puneet Souda (Senior Managing Director of Life Science Tools and Diagnostics Research)
Yeah.
Masoud Toloue (President and CEO)
You, you got cut off there at the end, but I got the first part of the question.
Puneet Souda (Senior Managing Director of Life Science Tools and Diagnostics Research)
Y- yeah.
Masoud Toloue (President and CEO)
So-
Puneet Souda (Senior Managing Director of Life Science Tools and Diagnostics Research)
Just if you could also talk about reference labs, competition, too. I mean, how do you, what do you think about that? Thank you.
Masoud Toloue (President and CEO)
Yep. So as I said, we looked at two different sample cohorts, two large sample cohorts. And, you know, I think when you start to look at a blood test that's going to be on the same playing field or could be the diagnostic test, meaning, you know, something to rule in or rule out, you're obviously doing it some comparator, either CSF or PET. And there, the two cutoff approach is, you know, incredibly important. So we use the two cutoff approach. It was recommended by the draft NIA-AA guidelines, and it basically establishes a three-zone test, and reflects low, intermediate, and high risk of amyloid pathology.
Samples reading below the cutoff are unlikely to have the pathology, and then samples reading above the upper cutoff are likely to have that pathology. So, I think that, you know, as we move forward, that becomes more and more the type of test that would be used if you're not going to be doing imaging or CSF. Then, you know, in terms of the sensitivity required, the guidelines, you know, the requirement is above 90% accuracy. Our assay had the sense and spec and accuracy in both cohorts, so that was incredibly promising.
I just want to, you know, remind folks that, you know, it's, it's measuring the p-tau 217 effectively in blood, getting the femtogram per milliliter sensitivity, and then doing it in clinical samples, where, you're looking at, you know, patients that are early stage, subjective cognitive decline, mild cognitive decline, Alzheimer's, dementia. That's a broad range. And if you want a test that's going to be able to effectively measure folks in the early stages of cognitive decline or, you know, in the future, pre-symptoms, you want a test that has the highest sensitivity, that's going to be broad-based for patients at all ends of the spectrum.
And so, you know, I think based on these guidelines and some of the things that, you know, data that we're seeing, not all tests and not all platforms are going to be able to do that. And we're happy that the Simoa and the 217 platform will be able to cover the broadest range of patients.
Puneet Souda (Senior Managing Director of Life Science Tools and Diagnostics Research)
Got it. Super helpful. And then, just wanted to, you know, clarify, obviously, you had the launch of 217, but, just, sort of the timing for the multiplex and sort of how, how do you think, additions to that 217, additional biomarkers, to... With that 217 are required, or do, do you think 217, given the significance of this biomarker, is now sort of adequate enough, for, for, for the field?
Masoud Toloue (President and CEO)
Yeah, good question. There was some of that discussion at the CTAD meeting, and I think, one thing I just want to make very clear is that, you know, 217 is very important for diagnosis, and that has been well established, based on what I said earlier. But, I also want to make clear that this is an evolving field, where prognosis, staging, differential diagnosis are all going to be important. You know, it's not, you know, one patient comes in, they're diagnosed, and that's it. There's treatment monitoring, there's following on the patient. And what we're seeing, if you look at the latest clinical trials and the research, it's going to likely be several multi-marker tests.
The sensitivity required for each of those biomarkers is going to be high. And so having a platform where you have wide bandwidth, wide sensitivity bandwidth, to be able to measure a tau at the same time as you're measuring a beta or a GFAP or NfL on the same run, same patient sample is going to be incredibly important. You know, I think you're right, 217 is the single marker for diagnosis. I think it can be enhanced with multi-markers and then staging, measurement of a patient over a period of time, and the prognosis is likely to be multi-marker based.
Puneet Souda (Senior Managing Director of Life Science Tools and Diagnostics Research)
... Got it. Okay, thank you.
Masoud Toloue (President and CEO)
Thanks, Puneet.
Operator (participant)
Thank you. One moment for our next question. Our next question comes from Kyle Mikson with Canaccord Genuity. Please go ahead.
Kyle Mikson (Equity Research Analyst covering Life Science Tools and Diagnostics)
Yeah, thanks for the follow-up, guys. So on 2024, if you analyze this fourth quarter guidance, like, the full year revenue for next year, which is in line with this year's levels, obviously, if the macro improves in the, like, you know, this fourth quarter run, it could run, it could be kind of conservative. But, you know, it sounds like the rollout of these new SKUs of assays could create some noise and possibly growing pains next year as well. So it's kind of, there's kind of a lot going on. So can you just kind of walk through the main swing factors that could get you to, like, above or below the double-digit growth target for next year? And then maybe any thoughts on cash usage in 2024 as well would be helpful too. Thanks.
Masoud Toloue (President and CEO)
I'll give a broad stroke there, Kyle, on sort of the operational efforts, and then Vandana can comment on some of the margin and cash. So, you know, what we're doing right now in Q3 and Q4 is really focusing a lot of our resources on upgrades of the product line in preparation for the new assay deployments. We believe, and you know, as you can see in the last several quarters, that these new assay deployments are going to be gross margin accretive. Now, while we're putting them into the line in Q3 and Q4, that's a lot of effort and a lot of focus from the team. But we expect those new product lines, as we've been, you know, investing in the last six quarters, will be positive for the business.
And, we'll be able to get those products to our customers in an efficient way and a lot faster. So we're bullish on that aspect of getting this there. And, you know, as I said in the very beginning of the prepared remarks, we have, you know, substantially completed a lot of the heavy lifting, and we're going to be now doing implementation in the last couple of quarters. So that's that. And then, the on the guidance for next year, you know, I think just similar to what Vandana said, you know, we're going to talk about that in February, and we'll have a better sense.
But, you know, we still have a strong view that our, you know, research business, you know, continues to be strong and that we're seeing that, you know, continued similar demand for sensitivity and for our platforms and solutions.
Vandana Sriram (CFO)
Yeah. I'd say, you know, very consistent with everything Masoud said, we do expect 2024 to come in with a position of strength and for us to be able to keep building off that. You know, on the cash side, the only other thing that I would add is, as Masoud mentioned in his prepared remarks, the way we think about the business is we will continue to drive the RUO business to more and more efficiency, you know, better performance, working better with our customers. So we'll continue to focus on that, and we'll continue to drive it towards getting to cash flow breakeven. We've previously guided to that 170-190 number for cash flow breakeven, and we'll continue to work towards that. At the same time, we will deploy some capital into diagnostics.
You know, right now it's really small, and right now it's really more focused on building out our infrastructure. But you will see us be very focused in where we deploy our capital and making sure that aligns to our strategy.
Kyle Mikson (Equity Research Analyst covering Life Science Tools and Diagnostics)
Okay, that was great. Then just one last one. Masoud, as we stack up all these options in Alzheimer's diagnostics, Quanterix clearly has the most sensitive tests. I think 217 kind of, you know, helped out with specificity, which I think is what will ultimately lead to that kind of rule-in type test for maybe screening. But how do you think about, like, what's a clinically meaningful sensitivity level for neurology biomarkers? And then on that note, like, what type of tests would be best positioned as a monitoring test in AD? Like, would the number of markers or the levels of some of these metrics matter for that type of a product rather than the one you've already announced to LucentAD?
Masoud Toloue (President and CEO)
Yeah, great question, Kyle. You know, the sensitivity, I would expect, a good test to have a sensitivity of 90% and above. So that the... That's the, I think, a threshold, greater than 90% accuracy, and to your point, strong specificity if it's going to be a rule-in test. So, I think that's important, for diagnostics. And then in terms of monitoring, you know, staging, monitoring, first, I believe that, a tau marker is in that multiplex, for monitoring and staging. But we also are seeing the importance of NfL, GFAP, and a few sort of new types of tau variants that we've been doing a lot of work on in our pipeline.
So, from a monitoring perspective, I could see it being multi-marker. And then, you know, differential diagnosis. Let's also consider that there are folks coming in to the neurologist office, and there are the signs of dementia, but we're not seeing the amyloid pathology. You know, then what? What is that? And there, I think the need for differential diagnosis is important. And there you'll for sure need additional markers beyond tau to be able to provide that differential diagnosis. So we're working with several partners. We're in a few clinical trials that are looking at this, including our own, where we're looking at a broad-based patient set in a multi-marker setting.
And I think the point of all of this is 217 is great, and it's, you know, we believe, the best marker for the diagnosis, but there's still a lot of work to do, Kyle, in research, in discovery, additional clinical work and testing for what's a much larger picture. And if you sort of look and squint at, you know, what we're seeing in the field and what's coming out from industry publications, it's going to be a multi-marker test that's going to require sensitivity for all the markers to be able to tell a whole picture.
Kyle Mikson (Equity Research Analyst covering Life Science Tools and Diagnostics)
Got it. Okay. That's perfect. Thanks, Masoud. Thanks, guys.
Masoud Toloue (President and CEO)
Thanks, Kyle.
Operator (participant)
Thank you. This does conclude the question and answer session.