Quanterix Corp

NASDAQ:QTRX

Earnings Call Analysis

Company Cuts Losses, Raises Revenue Outlook

The company saw a marked reduction in net losses, down from $35.1 million to $7.8 million year-over-year due to a successful corporate transformation that improved margins and reduced inventory losses. Non-GAAP gross profit improved to $15.2 million with a 48.6% margin. They are progressing through the last phase of their transformation, with upgrades to production lines and the introduction of new assays planned for 2024. Fourth quarter revenue is expected to hit $27 to $29 million, raising annual guidance to $118 to $120 million, with non-GAAP gross margins anticipated to be in the mid-40s for the fourth quarter, reflecting transitional costs. Full-year cash usage is projected to be $20 to $25 million, down from the initial estimate of $30 to $35 million, signaling better efficiency and strong demand for Simoa technology.

Improving Financials and Strategic Redirection

The company has shown a notable improvement in its financial health, with a significant reduction in net loss to $7.8 million in the third quarter of 2023, down from $35.1 million in the equivalent quarter of the previous year. This was driven by improved gross margins, which increased to 48.6% from 34.9%, and operating efficiencies leading to a lower cash burn rate. Moreover, due to the absence of impairment charges that affected the prior year's results, and increased interest and other income, the company stabilized its financial position, ending the quarter with a strong cash balance of over $330 million. The management's effort in transforming corporate operations has yielded fruit, cutting inventory losses and refining processes.

Bright Prospects with New Product Introductions in 2024

Looking forward, the company anticipates introducing new assays in 2024, which is expected to enhance the product offering and cater to the growing demand within the diagnostic market. Executives expressed confidence in the team's ability to scale operations and to fuel new product launches next year, suggesting a clear strategic vision for product development and growth.

Pursuing Partnerships and Expanding Market Reach

In the pursuit of expanding their market reach, the company has maintained partnerships, such as with Lilly, and is forging new ones, like the recent agreement with J&J. While they have not disclosed the financials of these deals, there is an expectation that the majority of economic benefits will stem from laboratory-developed test (LDT) and kit sales, as they aim to make their p-Tau 217 marker broadly available. Collaborations with industry leaders like Lilly are continuing and proving to be robust, as highlighted by encouraging data presented at notable conferences.

Continued Demand and Upswing in Consumables

Despite challenges like macroeconomic overhang affecting instrument sales, consumable sales surged by 63% year-over-year, signaling user engagement and a robust product utility. The company reported that it had effectively caught up with prior order backlogs and have resumed operating at steady-state, which could promise consistent revenue streams moving forward.

Advancing Diagnostic Capabilities and FDA Interactions

The company is not just riding on the current success of its CLIA CAP certified laboratory in Boston but also has plans to submit its p-Tau 217 marker for FDA approval in the coming quarters. Such proactive regulatory strategy, coupled with processes aimed at obtaining Medicare coverage, showcases a commitment to providing credible diagnostic solutions and ensuring sustainable growth. Gross margin improvements are noted in the short term, with longer-term goals of achieving margins in the early 60s. The focus is on new assay development which shows promise for both the gross margin and the company’s testing capabilities.

Cautious Optimism for 2024 with a Strong Cash Position

Looking towards the end of 2023 and into 2024, the company provided revenue guidance for the fourth quarter to be between $27 million and $29 million, increasing full year revenue guidance to a range of $118 million to $120 million. The careful and mindful resource allocation, primarily toward the completion of the production line upgrades, can be seen as a preparation for successful new assays deployment, expected to contribute positively to the business's gross margin. Management remains bullish on the ability to deliver its products efficiently and anticipates discussing more detailed growth targets in February but retains a strong view that its research business will continue to demand the high sensitivity offered by the company’s platforms.

Earnings Call Transcript 2023-Q3

[Operator]

Good day, and thank you for standing by. Welcome to the Quanterix Corporation Q3 2023 Earnings Call. [Operator Instructions] 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.

[Ed Joyce, executive]

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 transitioned 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 U.S. 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 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 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.

[Masoud Toloue, executive]

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 earning 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. As we said at the beginning of this year, our goals are ubiquity, such that the 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 '24, 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 for Alzheimer's disease, CTAD meeting, small-based blood biomarkers testing was revealed in several neural clinical trials for monitoring, measuring efficacy of neurotherapies and diagnostics. Simoa's ultrasensitive digital immunoassay technology delivers scaled, high-throughput measurements 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 I 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 frontal temporal 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 multicenter clinical trial sites, the early insights are promising. Reported in Nature Medicine in July, a 1,000-plus 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 2 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 Johnson & Johnson Innovative Medicines and launched the LucentAD p-Tau 217 blood-based biomarker test, combining Quanterix's ultrasensitivity 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 arise. Our p-Tau 217 test achieved sensitivity, specificity and an overall accuracy each exceeding 90%, meeting the criteria outlined in the revised National Institute of Aging and Alzheimer's Association, NIAAA 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. This validates the use of fluid-based biomarkers and puts it on the same playing field at the historical standard of PET imaging. 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, executive]

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 onetime 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 six-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 and $29 million. This increases our revenue guidance for the year to be in the range of $118 million to $120 million compared to our previous range of $110 million to $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 margins 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 million to $25 million, an improvement from our prior estimate range of $30 million to $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 Toloue, executive]

Thanks, Vandana. I want to copiously thank the entire Quanterix team for their hard work and focused effort. Dan, our COO; and Darrin, our CCO, have been relentless in this pursuit. As a result, there's been remarkable progress in building a solid and scaled operations platform for 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]

[Operator Instructions] Our first question comes from Kyle Mikson with Canaccord Gentuity (sic) [ Canaccord Genuity ].

[Kyle Mikson, analyst]

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, in the suit, could you talk about deal economics? I think with Lilly 1.5 years ago, that was about $11 million in accelerated revenue for about a full year. So curious if there's a comparison here? Then this agreement, was it brought on by any change in the relationship with Lilly and does Lilly remain an important partner for you going forward? Then maybe just one clarification. Will Lilly be using Simoa for its own Alzheimer's test because the company is working with other analyzers and assay vendors as well. So I'm just -- I get the question a lot about that. Thanks.

[Masoud Toloue, executive]

Thanks, Kyle. Yes, so the answer to your first question, we haven't announced any sort of deal economics on the J&J agreement that we signed. However, I would say that Quanterix expects the majority of the economics to come from our LDT and our kit sales and what we're doing with -- 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 on 217 is that we want to try to get it into as many hands as possible. We think that we -- our collaboration with Lilly continues and it's a very strong collaboration. They presented some great data at CTAD on the Simoa platform. So we expect that relationship to continue. Then on our LDT, it is using the J&J solution, but we want to make both solutions available to this market. I think you had a third question, I might have missed it there, Kyle.

[Kyle Mikson, analyst]

Yes, and so far, so good. It was the -- is Lilly going to be -- Lilly has its own Alzheimer's assay, right? Is that going to be based on Simoa or some other analyzer assay vendor?

[Masoud Toloue, executive]

Yes. So I think there was some clarity at the CTAD meeting. There was a strong analytical and early clinical validation of the Simoa platform in 217. As I view this, 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 I expect our efforts and collaboration to continue.

[Kyle Mikson, analyst]

That was perfect. It was good to see the NIAAA guidelines, I guess, the new recommendations recently. I was curious how influential those are? Two questions in terms of going against the grain and kind of ordering with these novel products, sort of like these tests that we're talking about here. Then how could those guidelines, if finalized, impact CMS decisions regarding reimbursement as well? Like, is that a key question? Given the size of tests, still pretty early days.

[Masoud Toloue, executive]

Yes. We agree with that, Kyle. I think it was nice to see the NIAAA guidelines and criteria. I think the -- while it's not a direct clinical recommendation, I think it has a big influence and to your point, could effect for their decisions down the road. I really totally agree with what came up in the guidelines. One, in terms of a blood test to -- if it's going to be a blood test that's on the same playing field as PET, 217 was a clear answer there. We've been working on this, obviously, with our partners for years, and the data has been pretty strong through the clinical trials. Then two, if you look at the accuracy that's required in blood, it was high and the sensitivity required is high. So I applaud the organization for really picking a great test and great marker for diagnosis.

[Kyle Mikson, analyst]

Perfect. One more before I hop off. Just on the P&L and, I guess, as you kind of break out, revenue. You guys have a lot of onetime items, if you parse those out, product revenue was a little bit softer than service. Service was quite strong. Product has the macro headwinds in there, but 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, 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 the service and accelerator revenue to drive growth?

[Masoud Toloue, executive]

Yes. Maybe I'll start with that and then Vandana if you have additional color. Well, first, I would say that we do think that 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 about, Kyle, say, 4 or 5 quarters when we announced the program and we built that quality wall, we added -- made sure things going out the door were going to be things that are going to be scalable at the highest level of quality. So throughout the year, there's always going to be a year of focus on our products and getting them in at the highest level to customers. So some back and forth. But overall, the consumables are going out the door to our customers, the utility and usage on a per platform basis is good. As you can see, a lot of folks want to come and use 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, executive]

Yes. I'd just add, 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, 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%, one extra instrument. But we do expect, 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, analyst]

Okay, and Vandana, what was the catch-up for consumables? That was super helpful. Just the catch up -- if you can quantify that, we're getting questions like that, too.

[Vandana Sriram, executive]

Yes. I'm not sure we can quantify it in dollar terms. But if you just look at our sequential improvement, we were at about [ $15.2 million ] 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. 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.

[Operator]

Our next question comes from Matthew Sykes with Goldman Sachs.

[Jake Allen, analyst]

This is Jake Allen on for Matt Sykes. I'll ask both my questions upfront. 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 test? 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?

[Masoud Toloue, executive]

Jake, so I'll take your first question. The FDA -- I mean, we've always said our strategy as an organization is to ensure that we're getting these tests out there as early and as fast as we can. So that mechanism has been through our CLIA CAP certified laboratory here in Boston. So that's the start. We also believe that these tests should also go through FDA approval, and our plan is to do that within next several quarters to make sure we have a submission on our 217 to the FDA. Then in terms of timing, that can take some time, of course, depends on the agency. But in the meantime, we think getting testing done through the CAP CLIA lab is going to be important.

[Vandana Sriram, executive]

Yes, 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. We had signaled 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 still -- we've previously guided to wanting to accomplish margins in the 60s -- 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.

[Operator]

Our next question is from Dan Brennan with Cowen.

[Daniel Brennan, analyst]

Maybe the first one just on the guidance. You've had some really good success here year-to-date. Just wondering on the fourth quarter kind of implied guide, it looks very conservative in light 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 how should we be thinking about that fourth quarter guide? Then if we cycle past the fourth quarter, are we still thinking double-digit growth expectation for '24 or just any early read there?

[Vandana Sriram, executive]

Yes, thanks for the question, Dan. So 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, starting up our second production line and having assays on the shelf for 2024. So with that in mind, 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 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 guides to a reasonable number. With that said, 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, definitely expecting the fourth quarter to have some of these headwinds and planning for that.

[Daniel Brennan, analyst]

Then maybe just one on 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? Then b, how should we think about timing for Medicare coverage on the various tests that you're looking to implement?

[Masoud Toloue, executive]

Yes, Dan. So on the Alzheimer's side, I think what we saw in the guidelines, I would sort of direct folks to the NIAAA guidelines. There, it was very clear that a test would need an accuracy that's above 90%. When we did this, we did 2 studies, one was the Amsterdam dementia cohort, around 500 individuals were tested. Then we also looked at the Bio-hermes trial, which was a multicenter site, 17 U.S. clinical sites. In both large studies, we were able to achieve accuracies that are above 90%, which is the guideline or the criterion in the draft NIAAA. So very happy about that. I think that's going to be the case for any sort of test that wants to try to be on the same playing field as PET. Then your second question was on timing of reimbursement. Was that the question?

[Daniel Brennan, analyst]

Yes, it was on Medicare. How do we think -- the pathway forward for Medicare?

[Masoud Toloue, executive]

Yes. So I expect the Medicare path, maybe initially will 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 NCD in the future. Hard to say from a timing perspective, but we hope that it gets the attention it deserves.

[Operator]

Our next question comes from Puneet Souda with Leerink Partners.

[Puneet Souda, analyst]

Masoud, so the first one, maybe -- and I don't know if this was covered, but there was a discussion of 2 cut assay to drive performance improvement at CTAD. Can you maybe just talk about that, if the p-Tau assay is structured that way? What's the performance level that we should expect here? There was also quite a bit of discussion on the performance that would be needed to deliver on p-Tau 217, where obviously, Simoa has done well historically. So maybe can you just talk about how Simoa's position [Audio Gap]products that are[Audio Gap]

[Masoud Toloue, executive]

Puneet, can you hear me? You got cut off there at the end, but I got the first part of the question.

[Puneet Souda, analyst]

Yes. Just if you could also talk about reference labs competition too. I mean, how do you -- what do you think about that?

[Masoud Toloue, executive]

Yes. So as I said, we looked at 2 different sample cohorts, 2 large sample cohorts. 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 something as a rule-in or rule-out, you're obviously doing it some comparator, either CSF or PET. There the 2 cut-off approach is -- you know, would incredibly be important. So we use the 2 cut-off approach. It was recommended by the draft NIAAA guidelines. It basically establishes a 3-zone test and reflects low, intermediate and high risk of amyloid pathology. So samples reading below the cut-off are unlikely to have the pathology and then samples reading above the upper cut-off are likely to have that pathology. So I think that 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 in terms of the sensitivity required, the guidelines -- 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 remind folks that 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 patients that are early stage subjective cognitive decline, mild cognitive decline, Alzheimer's dementia. That's a broad range. If you want a test that's going to be able to effectively measure folks in the early stages of cognitive decline, or in the future of 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. So I think based on these guidelines and some of the things, data that we're seeing, not all tests and not all platforms are going to be able to do that. We're happy that the Simoa and the 217 platform will be able to cover the broadest range of patients.

[Puneet Souda, analyst]

Got it. Super helpful. Then I just wanted to clarify -- obviously, you had the launch of 217, but just the timing for the multiplex and how do you think additions to that 217 -- additional biomarkers with that 217 are required? Or do you think 217, given the significance of this biomarker is now adequate enough for the field?

[Masoud Toloue, executive]

Yes, good question. We -- there was some of that discussion at the CTAD meeting. I think one thing I just want to make very clear is that 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. It's not -- one patient comes in, they're diagnosed, and that's it. There's treatment monitoring, there's following on the patient. 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, and the sensitivity required for each of those biomarkers is going to be high. So having a platform where you have wide sensitivity bandwidth to be able to measure a tau at the same time as you're measuring Aβ or GFAP or Nfl on the same run, same patient sample is going to be incredibly important. So I think you're right, 217 is the single marker for diagnosis. I think it can be enhanced with multimarkers and then staging measurement of a patient over a period of time, the prognosis is likely to be multi-marker based.

[Operator]

Our next question comes from Kyle Mikson with Cannacord Genuity.

[Kyle Mikson, analyst]

So on 2024, if you analyze this fourth quarter guidance, the full year revenue for next year, which is in line with this year's levels. Obviously, if the macro improves in this fourth quarter [indiscernible], it could be kind of conservative, but it sounds like the rollout of these new skews of assays could create some noise and possibly growing pains next year as well. So there's kind of a lot going on. So can you just walk through the main swing factors that could get you to above or below the double-digit growth target for next year? Then maybe any thoughts on cash usage in 2024 as well would be helpful, too.

[Masoud Toloue, executive]

I'll give a broad stroke there, Kyle, on the operational efforts and then Vandana can comment on some of the margin and cash. So 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 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 investing in the last 6 quarters will be positive for the business. 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. As I said in the very beginning of the prepared remarks, we have 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. Then on the guidance for next year, I think just similar to what Vandana said, we're going to talk about that in February, and we'll have a better sense. But we still have a strong view that our research business continues to be strong and that we're seeing that continued Simoa demand for sensitivity and for our platforms and solutions.

[Vandana Sriram, executive]

Yes. I'd say, 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. 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, 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 million to $190 million number for cash flow breakeven, and we'll continue to work towards that. At the same time, we will deploy some capital into diagnostics. 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, analyst]

That was great, and then just one last one. Masoud, as we stack up all these options in Alzheimer's diagnostics, Quanterix certainly has the most sensitive tests, I think 217 kind of helped out with specificity, which I think is what will ultimately lead to that rule-in type test for screening. But how do you think about what's the clinically meaningful sensitivity level for neurology biomarkers? Then on that note, what type of tests would be best positioned as a monitoring test in AD, with the number of markers or the levels that some of these metrics matter, for that type of a product rather than the one you've already announced to [indiscernible] AD?

[Masoud Toloue, executive]

Yes, great question, Kyle. The sensitivity, I would expect a good test to have a sensitivity of 90% and above. So that's the, I think, a threshold-- greater than 90% accuracy. To your point, strong specificity if it's going to be a real end test. So I think that's important for diagnostic. Then in terms of monitoring, 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 multimarker. Then differential diagnosis. Let's also consider that there are folks coming in to the neurologist's office, and there are designs of dementia, but we're not seeing the amyloid pathology. Then what is that? 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 multimarker setting. I think the point of all of this is 217 is great, and 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. If you look at, squint at what we're seeing in the field and what's coming out from industry publications, it's going to be a multimarker test that's going to require sensitivity for all the markers to be able to tell a whole picture.

[Operator]

This does conclude the question-and-answer session. Thank you for your participation in today's conference. This concludes our program. You may now disconnect.