Financial year 2022 results. An important disclaimer. Note that by participating on this call, you agree and understand these terms and conditions. Today with me, I also have our CFO, Grant Gibson, who will be speaking to some of the financial results and also available to ask questions. Our agenda for today is focused on some highlights of the results, a little bit about the company, a look at our operational performance over the financial period, and then some framing of our investment program, based on the capital raise we did last year. We'll look at the specifics of our financial performance, and we'll make some statements regarding the outlook, and then there'll be the opportunity for all of you to ask us questions. Diving right into the highlights.
Global testing volumes are up 46%. U.S. testing volumes, total laboratory throughput are up by 59%. Growth in operating revenue is up 49%. All of this comes with a slight increase to NZD 19.8 million net loss after tax. Importantly, we still have a very healthy cash balance with NZD 105.4 million cash equivalents, and short-term deposits. Importantly, Pacific Edge, after going through a CEO transition, is now set to build on the success with an investment program framed by three pillars. These are research and innovation, evidence coverage and guidelines, adoption, retention, and revenue generation, and these will feature through the call.
Pacific Edge is on a mission to help improve people's lives and patient outcomes by providing leading solutions for the early detection and management of cancer. We envision a world where the early diagnosis and better treatment of cancer is within the reach of everyone, because we believe that nobody should die from cancer. Pacific Edge at a glance. Geographically speaking, we have labs in Dunedin, New Zealand, and we have labs in Hershey, Pennsylvania. We have active clinical study partnerships in both of those countries, as well as Australia, Singapore, and more recently, Canada. We use our clinical studies partnerships as ways to seed new business in those locations.
Pacific Edge has strong IP, builds the technology and that IP into great products like develops the clinical evidence through peer-reviewed clinical validation and utility studies, and then focuses on the commercial angle by obtaining reimbursement from key payers like Medicare and Kaiser. We also focus on patient empowerment with non-invasive efficacious testing, offering the opportunity for increased patient compliance and surveillance in management regimes. Urothelial cancer is a significant global healthcare challenge. You know, Pacific Edge is laser-focused on the U.S. market, the largest single market, and that is where we already have established reimbursement. One of the reasons we focus on the U.S. is not just that it is the largest, but also the market understands that the best-in-class innovations may need a higher price point.
With our established reimbursement at $760 per test for Medicare, that validates that hypothesis. It is also the most advanced healthcare system, meaning that a greater percentage of the population receive the gold standard of care. But importantly, we note that there are large population centers outside of the United States, and we've done some basic modeling of international markets to determine a global total addressable market. This modeling assumes lower cost per test in rest of world regions, uses the baseline figure of incidence from the AUA and clinical practice of value-based healthcare in capitated systems. I wanted to spend a little bit more time on this particular slide. This will be a new slide for many of you.
This is a key way of framing the market that we operate in. Molecular diagnostics have been around for decades now, and have slowly been revolutionizing patient care. I thought it would be important to highlight the framework for you, within which Pacific Edge identifies value for the clinicians and patients along the patient journey. We conceptualize the value of molecular diagnostics in four major areas of the patient journey. The first of these being genomic screening, or your genetic risk at birth. Looking at the genes of an individual and determining if any of these genes are known to be correlated with increased risk of disease, for example, in oncology diagnostics, BRCA1 or BRCA2.
During our lifetime, and potentially, due to lifestyle or other factors, the disease may manifest, where may be no physical symptoms, that a person or patient can identify. In that case, the patient may not actually see a doctor, and they would be in asymptomatic. Tests designed to detect disease in asymptomatic individuals are typically called screening tests and offer the earliest way to detect the onset of disease. The challenge is that the incidence prevalence of disease is extremely low, which requires enormous clinical studies to validate. This is a major challenge for healthcare funders to justify. Nonetheless, there are examples where this is gaining traction, because early detection does give the best possible treatment options to eliminate the disease.
Moving forward in the patient journey, we get to the point where a patient observes symptoms and typically chooses to see a doctor, and there they enter the patient care pathway. In the case of Cxbladder, this is the presentation of hematuria or blood in the urine. This is the segment of the patient journey you'll find the majority of diagnostic tools used to assist clinicians with decision-making for patient care. If the conclusion from the clinician is that therapeutic or surgical intervention is necessary for a patient, then you move into the fourth segment of the value chain. Here, diagnostics try to answer questions like, did the therapy or surgery work? With tests for residual disease or therapy response monitoring to answer the more real-time question, is the therapy working?
In the case that is relevant to Cxbladder products, is there recurrence of disease? What we'd like to do next, though, is zoom in and focus on the nuance of where Pacific Edge has developed its portfolio of products and how we add value to hematuria evaluation for UC and surveillance of recurrent UC. Cxbladder has three commercially available products, Triage, Detect, and Monitor. I'll focus your eyes on the right-hand side of the slide to understand the value proposition of each of those. In the center of the slide, understand where in the patient care pathway the tests are used. Triage is used in the earliest parts of the patient care pathway to assist clinicians to safely de-intensify hematuria evaluation from low-incidence population.
Cxbladder Detect is used in the center of the pathway, primarily by secondary care urologists, and assists clinicians to adjudicate diagnostic dilemmas, for example, equivocal cystoscopy and atypical cytology in any patient population. Then we have Cxbladder Monitor used after therapeutic intervention or surgical intervention, again, used by secondary care specialist urologists to assist the clinicians in monitoring for urothelial cancer recurrence, intended to reduce the frequency of surveillance cystoscopies and improve patient outcome. Focusing specifically on the U.S. market, and building on the earlier slide where in the patient journey Cxbladder can deliver value, we wanted to highlight one of the common comparators. You've seen this, historically if you've been following the company for a while.
We've introduced another measurement here or another where cystoscopy fits in the patient care pathway. What you'll notice is that there is significant drop from those patients that require clinical workup for the suspicion of urothelial cancer and those that ultimately get a cystoscopy. This is important when trying to determine the market size for Cxbladder, because we intend our products to be used on the 3.4 million patients requiring clinical workup for urothelial cancer, and not just as an alternative for cystoscopy. It is our view from talking to key opinion leaders that all of the patients require a clinical workup are the target population of Cxbladder when used to risk stratify patients prior to cystoscopy.
This is what drives the figure of a 4.6 million testing opportunity and a $3.5 billion market. Moving on to operational performance. On this slide, we'd like to draw your attention to firstly, the COVID impact on FY 2021 on global testing volumes, which you can see on the right-hand side. FY 2022 has been a recovery year. This is also mirrored by the commercial testing volumes, that is the lower graph on the right-hand side. We also want, I want you to note that as the majority of our growth during this time has been in the U.S. market, and the primary product in the U.S. market for hematuria evaluation is Cxbladder Detect.
We have seen an increase in the percentage of Detect as a percentage of total tests between FY 2021 and FY 2022 if you look at the two donut plots as you go from left to right. Focusing on our sales activities indicated our U.S. commercial efforts. We've actually seen a 59% increase from FY 2021 to FY 2022. Noting also that commercial testing is approximately 84% of total laboratory throughput in FY 2022. We thought it was also useful to inform you how our sales activity is nationwide. Of course we are clustered in the population centers and where we've seen the highest level of traction so far.
Again, historically, we've talked about how COVID has impacted our business, and we wanted to share with you a little detail behind what we mean when we say that COVID has impacted our business. To do this, we've started the timeline for these two figures just prior to the start of the pandemic, January 2020, and going through to April 2022. However, since the impact, we believe it's important to highlight that we can grow despite those market headwinds.
With fairly sizable dips that you can identify in these graphs, associated with individual waves of, particularly for Delta and Omicron, the way this has affected our customers is access to our customers by our sales force has been a challenge, and access for patients to their providers has been a challenge. That is something that we now believe, based on recent rulings in the United States in terms of mask mandates waning, access is improving and that hopefully we will see a greater uptick or less impact from COVID on our sales operations. Again, focusing on the Americas, it's important to note that we've already activated some of the and met some of the most important milestones in terms of reimbursement.
In the United States, our business is third-party reimbursed, which means the payment comes from the government payer, CMS, or from private payers. CMS is by far the bulk of all of these. I think historically, we've shared with you that it's roughly two-thirds of our patient population are those with Medicare coverage. You know, the reasons behind that are that we have an age-biased population. The average age of somebody presenting with hematuria is over 70, and typically people over 65 have the option for Medicare insurance, and so usually qualify for insurance with Medicare. Consequently, our payer landscape skews towards Medicare. Importantly with Kaiser, a health plan that covers 12.5 million members, and greater than 85% of those are actually in California.
We have already reported to the market that, following a utility evaluation internally, that Kaiser is rolling out our test on a site-by-site basis and physician or clinician-by-clinician basis, starting in the Southern California region where it was evaluated and discontinued. Volume growth is steady and is expected to increase, but not in a step change manner, but at a faster rate, once we secure electronic medical record integration. This is viewed from the perspective of the business as a marathon and not a sprint. We have no new updates at this time about the status of the EMR integration, except that we are in ongoing contact with Kaiser to move that forward.
Importantly for both Kaiser and the Veterans Affairs, both sites, both organizations are adopting Cxbladder Triage, and Cxbladder Triage does not yet have Medicare coverage. Adoption at these two sites will help drive the ultimate case for reimbursement by CMS in the U.S. market. Addressing the commercial situation in the Asia Pacific region. New Zealand is at the forefront of adoption here, with more than 70% of New Zealand's population already covered. COVID restrictions did fairly severely impact our progress in the New Zealand market. The growth is slower than we would have liked here.
We do also anticipate that growth will be slower given how many DHBs are already signed up and are under individual DHB agreements. However, there are two very clear opportunities, the first of which is the consolidation of the District Health Boards. It represents an opportunity for expansion of Cxbladder to those DHBs that have not historically had access. Similarly, it represents an opportunity for us to promote the use of Cxbladder in the consolidated District Health Boards in a way that it is used in Canterbury, i.e., at primary care. You know, which is an additional opportunity for growth for Cxbladder in New Zealand.
Early commercial testing volume has been received from Northern Health in Melbourne, and we have ongoing clinical studies at nine other Australian hospitals that are trialing Cxbladder, and we will look to convert those through the course of the next year. The Singapore clinical studies have completed their enrollment, and we are in the process of developing a business case to determine the go-to-market approach for Singapore and the rest of Southeast Asia. The future of Pacific Edge, we wanted to set up a framing for our investment program and how we intend to spend the money that was raised during the capital raise last year. I wanted to make clear our framework for presenting these initiatives to you.
We've identified three major themes for our initiatives and how we create value as a company. You can see those in the three large circles in the middle. We have research and innovation, we have evidence coverage and guidelines, and we have adoption, retention, and revenue generation. Into that value creation framework, we have our inputs, our people, our processes, our IT, knowledge and experience, our clinical studies partners, and our investors. Those inputs into our value creation program has an output that is focused on patients. Where we expect excellent patient experience and accurate results reported to those patients because patients always come first and guide everything that we do. We develop early detection and clinically actionable care for a physician.
We continue to innovate and build a pipeline of that innovation for clinical application. We operate an inclusive workplace driven by outcomes, and we expect increased long-term shareholder value from all of our value creation. Having taken my first 90 days to understand the business, I wanted to establish the view that when we look at our research and innovation, we also look to commercialization because it's important that we're discussing research innovation that we understand our path to market and our path to reimbursement. Our focus areas as we move things from intellectual property through to technology, through to product and into the market are to evaluate product concept, to evaluate cutting-edge technologies, and using that to continue to build a patent portfolio of novel clinical applications with cutting-edge molecular technology.
Turning patent technology into clinically valid molecular diagnostic tools that address an unmet clinical need. As we drive IP through to technology, what are our achievements in FY 2022? To a certain extent, some of the tests communications on the test have to be carefully managed, because a lot of the, you know, IP to technology, it can be commercially sensitive and too material. We would like to highlight a couple of more. First, we did publish the TDR study, the Cascade of Triage Detect and Resolve, a study which highlights how our current tests can be used in combination, including Resolve, and also Resolve on its own.
An important point that we wanted to make on this slide, because it's an obvious source of question for those who've been following the company for a while, is that Resolve is a great product at what it does, in terms of its ability to provide insights in distinguishing between high-impact tumors and low-impact tumors. As we validated this product with the opinion leaders in the market, their feedback was clear, that whether a tumor was high impact or low impact, it wouldn't change their clinical practice. Now, this is not a negative for Resolve. In fact, it guides us very clearly as to where we need to take Resolve, to have it be a clinically actionable product.
Resolve is back in our R&D process, and we're evaluating the various product concepts that it can become. There are some exciting possibilities that I won't be sharing today, but I do want to reinforce that we are optimistic that when we can adapt Resolve to have an even greater clinically actionable impact, we will be advising the market of that. Most of this is already underway, and I look forward to telling you more about it when we make that progress. In the near term, for FY 2023, we expect to publish results from our Singapore study that the data analysis is complete. The publication is pending, and we are working through with the authors to have that through as soon as feasible.
As we have good coverage of the patient care pathway from a diagnostics perspective, we are intending to explore other products in the prognostics and companion diagnostic space in our core market for urology. Furthermore, we will evaluate opportunities that leverage our core competency, which is identifying molecular biomarker signals from urine. That may mean looking for adjacent cancers and other disease in urine. Again, we won't be disclosing any specifics beyond that at this time, but as and when those product concepts mature to a point that it makes sense to communicate to the market, we will do so systematically. Evidence coverage and guidelines is an extremely important near-term area where we are going to place a lot of emphasis at Pacific Edge.
It is a cornerstone of the initiatives that we will fund from our investment program. At a high level, we want to establish the understanding that Pacific Edge has historically done a great job of developing clinical validity evidence. Following that, still has plenty of work to develop clinical utility evidence for our products. It's the clinical utility evidence that guides the guidelines committee members to make decisions. Consequently, our initiatives here will focus primarily on utility evidence, which typically involves comparator arms and randomized designs in the clinical studies to demonstrate superior outcomes of our technology versus current standard of care, using endpoints that the KOLs and the folks that sit on guidelines committees agree are the appropriate endpoints to demonstrate clinical utility.
These utility studies typically have a slightly higher cost and run slightly longer than the validity studies, but Pacific Edge is well-placed with many of those already underway, and I'll elaborate on those in a future slide. Importantly, such clinical utility studies increase the protection that we enjoy of the urology market by building a bigger and bigger wall for our walled garden for Cxbladder. This investment is important for that. When we talk about guidelines, you know, hopefully, we've done a good job to date in communicating to the investment community the importance of the guidelines.
We want to reaffirm that position here by emphasizing that we understand the requirements of the guidelines committee, both through their formal communications with us and through the informal communications we have when we visit them at their practices, and when we spend time with them at conferences. Pacific Edge targets three major relevant guidelines groups, and that is the AUA, the EAU, and the NCCN. The way that we can influence guidelines committee or the most compelling way that we can influence the guidelines committee is through the publishing of new clinical evidence, and that's why our publication roadmap is so important, and our ongoing clinical studies are so important. Another important element of guidelines inclusion that we wanted to clearly articulate to the market is that inclusion is not a one-time deal.
Once we're included in guidelines, we will continue to generate evidence for additional for the use of Cxbladder in additional contexts of use, which means expanding the different patient types or areas of the care pathway in which Cxbladder is validated for use. Importantly, what we do before guidelines inclusion and what we do after guidelines inclusion is to focus on execution in the market. That is the third major pillar of our initiatives. Now, the following two slides summarize the clinical evidence that we are generating at the moment or have generated. The U.S. primary study and the Singapore study are both in the publication pending stage. We've actually ended up combining those two studies, and they are under author review right now.
One of the other things that you will likely notice is we've had a little bit of fun internally, coming up with names for our studies. There is a serious side to this activity as we believe it is crucial from a marketing perspective to have strong identification of our studies within the urology and oncology community. We can link, we hope, to bring the investors along for the ride on the evidence generation journey and believe it will also make it easier to identify our progress of these studies that necessarily take a number of years to complete, and are important for us ultimately getting in guidelines. We also aim to make this kind of thing a feature of our website going forward.
The last two studies on this list, STRATA, which is a randomized controlled trial, focuses on Cxbladder Triage as the primary product of study, and demonstrating utility for de-intensifying or ruling out patients at the earliest point in the care pathway. We've noted the specific clinical need that we're targeting for each of the guideline committees in each study, which you can see by the last bullet in each of these categories here for each of these studies. DRIVE is the name of our ongoing Department of Veterans Affairs study, and its product focus is also Cxbladder Triage.
It was recently expanded to accommodate more patients with the intent to increase the size of the low-risk patient subgroup in the study, to develop greater evidence for guidelines inclusion language. This, again, was based on KOL feedback, key opinion leader feedback, that separating out low-risk and high-risk patients in our analysis will provide stronger evidence, for the utility of Cxbladder and what the guidelines committee are looking for. Just mentioning, three additional studies here on the second slide. DEDUCT is the name we've given to a study that focuses on Cxbladder Detect, targeting a particularly high-value unmet need, which is the avoidance of unnecessary ureteroscopies, which are different from cystoscopies. This is an expanded context of use for Cxbladder, to the upper tract.
As it's just an expansion of the context of use, it doesn't need to be a large study, but it needs to be targeted. We've already identified four sites, but none of those are yet enrolling. LOBSTER is a newly announced study that will focus on the clinical utility of Cxbladder Monitor to safely risk stratify patients under the surveillance for recurrence of urothelial carcinoma. Again, targeting AUA guidelines inclusions for biomarkers as an alternative to cystoscopy and surveillance testing. MONSTER is a newly announced study that is in planning, and we're going to work initially with the Canterbury District Health Board to measure tumor burden in a monitoring setting. If this is successful, we will expand it.
That moves us on to the third area of focus, which is adoption, retention, and revenue generation, summarizing our execution priorities. The focus areas include diversifying our sales process in terms of the types of roles and recognizing that the United States is not a unimodal market. Drive protocolized adoption of Cxbladder at the earliest point in the patient care pathway. We plan to increase event marketing sponsorship, marketing communication, and establish indexed contracts when we can and when it makes sense.
Empower patients through patient awareness and patient advocacy initiatives through the established societies and also through our own website for Cxbladder. For the specifics of some of this in the Americas, we're taking a phased approach to everything that we do. We expect to hit various revenue milestones, you know, before we will trigger some of these. It is our intent to hire up to nine additional account executives and one regional sales director during the course of FY 2023. Add an additional two headcounts to the marketing and sales support managers. Add up to five FTE in a new virtual sales team, and add up to two individuals for strategic account sales.
Another important effort is our focus on medical affairs and all of the clinical studies that I just talked about, you know, while we have excellent resources in New Zealand, we do need to augment that by having excellent resources in our paid USA business. We have recently hired Tamer Aboushwareb to be our VP of medical affairs, who will lead a team of medical science liaisons. Their focus is on clinical education of engaging with key opinion leaders. One of the key things that we're targeting is more podium presentations by Pacific Edge and also by the KOLs that we work with.
In additional initiatives in the Americas, from a marketing perspective, we're going to be focusing on conference podium presentations and posters. Increase advertising, where we recently had quite some success at the AUA meeting. Increased and targeted MarCom activities. Focus on communication to the urology community and to the oncology community, but of which we would like investors to be aware, but will typically not be a material that needs disclosing. We want to focus on customer experience, and that has three elements to it.
To focus on electronic medical record integration, to focus on in-home sampling and to focus on managed care, which is an element that's really important in the United States healthcare landscape, where we simplify the process for explanation of benefits handling, billing and claims processing. We're going to run a series of initiatives there to make sure patients are having the best possible experience. In the Asia Pacific region, we're going to continue to focus on adding additional DHBs, you know, as we lead up to the impending amalgamation of the District Health Board. The most important initiative that we have is driving the adoption of the Cxbladder towards primary care. We already have market development in Australia through the clinical studies that we have there. Likewise in Singapore.
Having commenced commercial revenue in Australia, we're going to look to scale that. We will look to deploy resources that are across the Asia Pacific region, not necessarily country specific, but looking for the best opportunities across the entire region. In building the Cxbladder brand and the advocacy for patients, we have some planned partnership activity with BCAN, the Bladder Cancer Advocacy Network. We've already scaled up these activities, and we're a key sponsor for the Walk to End Bladder Cancer, which is a national deal. We sponsored walks around the country.
If you want to follow how we are engaging, we typically post a lot of photos from those kinds of events to our LinkedIn accounts, and you can see what we're doing there. Importantly, we also have an opportunity with BCAN to co-develop the various leading patient resources, including drafting the section on biomarker education for the primary patient resource that every bladder cancer patient when they get diagnosed gets told by BCAN, "Please go here and download this document." That's a great opportunity for us to highlight for patients how they have non-invasive alternatives.
In the Asia Pacific region, we also have planned partnership activity that largely revolves around the Bladder Cancer Awareness Month. In May 2022, you know, we've focused on developing educational videos to promote awareness of bladder cancer symptoms and the risk factors among high-risk groups. But our commitment to working with the Cancer Society and building out patient resources on our website is something where we're going to continue to deploy more resources. With that, Grant, I hand over to you to talk us through the financial results.
Great. Thanks, Peter. As Peter has mentioned, it's included on slide 16, the impact that COVID's had in certain periods with Delta and Omicron. Despite that, we've still seen solid growth of 49% in our operating revenue. That's up NZD 3.7 million to NZD 11.4 million for the year ending 31st of March 2022. Seasonally, what we have seen, though, is from March through to last week, increase in volumes as COVID starts to wane and the impact of our ability to get into clinics. The investment that we've been making into sales and marketing is beginning to have an impact. Our throughput from April through to last week was up 25% on the average of last year, which is a strong result.
We've mentioned as well the importance of U.S. on the future success of Pacific Edge, and the U.S. accounts for 93% of revenue, just to show you the extent that, and the focus that we're putting in investment into that area. Take you through some of the top line numbers. Throughput's increased 46%, which has led to 49% increase in operating revenue. Pleasingly, that's also led to significantly increased cash reimbursement. Cash reimbursement was up 62% on the prior year. That's reflecting the high levels of reimbursement we're receiving, and we're continuing to work on that as focus. Our operating expenses were up NZD 9 million- NZD 33.7 million for the year. That's an increase of 37%.
There's a couple of things to note on that the 2021 year was artificially low as it was impacted by a far greater extent by COVID as we restricted our marketing resources and our sales reps didn't have access, so it significantly reduced the costs. The other thing is the investment in operating expenses as we look to grow. 56% of that increase in operating expenses relates to sales and marketing, with people costs being the largest component of that. The increased investment has seen the loss of the company increase by NZD 5.5 million- NZD 19.7 million. That's an increase of 39%. When you reflect on an increase in operating expenses of NZD 9 million, that increased loss is understandable. Looking at those increased costs.
As I mentioned, the largest component of that is sales and marketing investment, and that's increased by 55% year-on-year and makes up 56% of the increased costs. The other major component is general and admin. That's up by NZD 2.3 million year-on-year. Of that, NZD 800,000 relates to dual listing on the ASX. The other two major components are laboratory operating expenses, which increase in line with volumes and R&D operating expenditure. That one has been impacted to a greater extent with the inability to get recruitment in some of our clinical trials, which is now coming off. We're expecting to see that investment continue in the years ahead. Great. Thanks for that. I'll hand you back to Peter.
All right. Just the last slide here on our thoughts on the year ahead. You know, Pacific Edge expects its investment in innovation, evidence, people, and brand to drive growth in test volumes and revenue. We also expect that the selling environment, including international travel, will improve with COVID restrictions easing as the disease becomes endemic. Consequently, Pacific Edge is excited and optimistic that the investment priorities outlined here are well-aligned with long-term shareholder value and that we remain well-positioned to deliver that over the coming years. With that, we open ourselves up to questions in the Q&A.
Right. We have got some questions that have come in online. We'll take a few of those, and then I think we'll open it up for any verbal questions or any questions from people that want to ask directly. The first question has come in from Andrew. Thank you, Andrew. With the clinical studies completed and those underway, how does this tie in with AUA's timeline when they review the clinical pathway for the inclusion of Cxbladder tests? And would the AUA be willing to revise their guidelines of new clinical evidence as it appears, as opposed to a fixed timeline of reviews?
Yeah. The AUA doesn't have a very strict or rigid timeline for reviews, and they won't review at all if there is no new clinical evidence published in your area. The guidelines committee re-meets roughly every two years, but if you want them to evaluate your area within guidelines, you do need to publish clinical evidence prior to that window. That's why the challenge for us, you know, regardless of the timing of the guidelines committee meeting, we can only trigger an interest from the AUA by publishing.
Our focus is on publishing the evidence that we have as quickly as we can, but obviously only when it meets a threshold from our understanding that it could change the opinion of the key members on the guidelines committee.
Great. Thank you. Good question, Andrew. This one is from Ian. Is there any chance of getting more updates on lab throughput and commercial uptakes twice a year in this environment? Leaves a lot to be desired.
We have received that feedback from a number of different avenues, and we're taking it under consideration about what kinds of information we could release on a quarterly basis. We don't make a firm commitment here today, but we'll evaluate that, and try to put together something that makes sense to release on a quarterly basis.
Great. Thank you. Next question. Are the cost benefit savings being explicitly evaluated? Do you have studies planned to evaluate these savings better?
I guess the question refers to the health economics of using Cxbladder in larger systems. We've done some modeling for our folks in the U.S., and we also have some anecdotal evidence just from talking to them that it certainly does save revenue in certain environments. We are in the process of doing that analysis in a formal way that it will actually well, ultimately be peer-reviewed and published if we can get there. It's important to recognize that in the U.S. market, there are actually three different stakeholders that may have a health economic interest. One would be the actual practice or a urologist.
Another would be the health system, if you practice in a health system, and then the third would be the payer. The strongest economic arguments we believe are for the payer, but it is something that we want that conclusion to come from doing the work. We have engaged a health economist to try to move that project forward. I can't give you specifics on a timeline as to when that will be achieved. The first step is to build a theoretical model of how we would save costs, and to those three stakeholders that I mentioned.
The second phase would be to actually demonstrate that in a kind of case study, which would be similar to the clinical study, just recording the economics of the change as well.
Great. Thank you. This one's from Dr. Steve. Are you marketing to the UK and other countries with national health systems where the cost savings for them could be huge?
Currently, we're not marketing in the UK and other systems where the cost savings could be huge in Europe. That is something we are currently evaluating as to where the best way to go internationally is. It's the subject of an ongoing strategic discussion internally.
Great. Thank you. Thank you for your question, Falwin. That is, what's your timeline for investor publication of Singapore?
The publication, again, as I mentioned, we don't have a strict timeline because it's often, there are a lot of stakeholders to corral to get this over the line. As mentioned, the enrollment is complete, the data analysis is complete. The publication is currently being reviewed by the authors. At that point, once the authors have all agreed it's ready for submission, it will go to, ideally, our preferred journal, and we are hoping for a high-impact journal. Then it is up to the journal's timeline as to how long that takes. We will make an announcement to the market when that has been accepted through a peer-review process.
In our view, it should be in the low numbers of months or high numbers of weeks, but any more specific than that is not possible.
Great. Thank you. A couple of questions that are similar vein. AJ and Shane, thank you for those. What are the preconditions for PEB to get cash flow breakeven? What is the timeframe for those?
We can't commit to that at this stage in terms of we don't have certainty around that timeline, but we do long-term modeling. You know, we are not expecting to add any additional capital to require us to get to being cash flow positive. We expect to, you know, modify our burn rate accordingly so that we can use the current investment to become cash flow positive.
Great. Thank you. Thank you, Richard. You note that the CMS funds Cxbladder when it is medically necessary. Under which situation is Cxbladder medically necessary?
That does get kind of down in the weeds of the LCD for Medicare. The most important element of whether something is medically necessary is when a physician says it. If a physician is evaluating a patient for hematuria with Detect, and then the test, when it is ordered, can be medically necessary when signed by a physician. Sometimes there may need to be additional supporting evidence. For example, they may need to provide results that show, yes, this patient did have blood in their urine. Yes, they are this ICD-10 code. If those criteria are met, then typically the threshold of medical necessity is met.
Occasionally, private payers who are administering Medicare Advantage plans may push back and ask for additional evidence. Yeah, that really is down in the weeds of claims processing.
Great. Question from Peter. In earlier years, you commented around the potential to recover payments for tests conducted prior to the CMS reimbursement agreement. Is this action still underway? If so, when do you expect resolution?
I have communicated that. It is clearly stated in the annual report. We have covered all avenues possible to seek reimbursement, and we stated in there that there's no further potential for the fees to recover any of those 22,000 tests. There'll be no further action possible for us to recover that. Disclosure in the accounts going forward won't be included.
Okay. There's a question here from Ken. Thank you, Ken. I hope Dunedin's fine down there. There was a comment in the Pacific Edge release to the NZX about R&D for non-cancer-related products. I assume that means non-bladder cancer related products. Does this open the potential of direct to consumer or direct to GC opportunities for more than general health assessments?
There's a lot to unpack in that question. Just to maybe clarify the statements from the NZX release. We are looking to create product concepts and potentially develop intellectual property based on the evaluation of cutting-edge technology in areas where we have core competency today. That is looking for biomarker signals in the urine, and biomarker signals in the urine may be used for other cancers. Also may be used for other non-cancer diseases. They may be used for other areas of the urothelial cancer pathway where we currently you know or where there is currently an unmet clinical need, and all of those three are possible leveraging our core competencies.
Great. Thank you. Are your sales team getting back to in-person meetings, and how is this helping with test uptake? Thanks, Shane.
Yeah, I actually had the good fortune recently myself to attend an in-person meeting, the AUA meeting in New Orleans, which is one of the largest meetings for urology. We had an expanded presence there with our KGS-I team. The short answer to the question is yes. That large meetings are now taking place in person. Smaller meetings are taking place in person. We do expect that will have a positive impact in terms of how we're able to you know just additional touch points with contacts who already know us. Having creating leads for comp...
with accounts who don't already know us, and then creating follow-up of all of that, in a you know a well-established you know lead conversion qualification process. Leveraging not just the direct sales force but also our virtual team.
Great. Thanks. Thanks, Rob, for your question. Any update on Northern Health Triage rollout, and how has this impacted financial year 22 revenue?
No major updates from Northern Health. They are a single hospital. They continue to send patients to us. I don't know personally the breakdown of monitor versus triage, but I understand the majority of them are currently monitor.
Great. Thank you. We've got one last question here around a request to break down the US accession volumes by test type. I can answer that. We don't go to that level of detail at the moment, but as we talked about with looking at quarterly updates, that may be something that we look at doing. That's the end of the questions that have come in. Operator, are you able to take any calls or questions directly from people on the call?
Yes. Ladies and gentlemen, if you would like to ask a question, please signal by pressing star one on your telephone keypad. If you are using a speakerphone, please make sure your mute function is off so that other people can hear you at that moment. A voice prompt on the phone line will indicate when your line is open. Please state your name before posing your question. We will take the first question from Christian Bell. Go ahead, your line is open.
Yeah. Hi, team. If I could just start my questions with slide 16 of your presentation. While the average test volumes are increasing, this is only due to the number of users. Like, the average test per user is only 3 a month quite consistently over two years. I guess my question is why is this utilization so low? What's holding the urologists back from using it more, given that some have been using it for over two years now? I guess before you answer that, is that because it's only being used for unique cases? For instance, equivocal cystos and atypical cytology, in which case the TAM is only a subset of the larger market.
I think it's following, you know, a relatively standard adoption curve. You know, where they do adopt the test in niche applications first, but it's slowly scaled to adopting in more contexts of use. What you're seeing is that the largest number of clinicians are using it for the, I guess the smallest or the niche application. There are definitely positive signs from a large number of urologists that they're using it increasingly earlier in the patient care pathway. We expect that, you know, it's a focus of our sales efforts to continue to drive that.
To take those small numbers of the ones, twos, threes, analyze how they're using it, and encourage those physicians to use it earlier and earlier in the care pathway for the patient.
I'm just wondering, Peter-
Just wondering, Peter, whether it's worth sort of highlighting. We mentioned it in the past briefly about some of the what we call internally stickiness initiatives.
Yeah. We are focused on a number of initiatives to address that. Which is the electronic medical record integration to ensure that ordering tests is easier, so that they'll order it on more patients. The patient in-home sampling system so they can order it on patients even when they're not coming into the office. And focusing on the utility, the evidence generation portfolio, which ultimately once through guidelines, then people will have no reason not to use the test because it will become a standard of care. That's the bigger picture.
I get the, you know, it takes a while for them to get comfortable with that stuff. When you look at the graph, some of those users have been using it for over two years now. I guess the average monthly rate hasn't increased at all. I mean, what's preventing the people back in January 2020, February 2020, from increasing their own utilization?
I don't know that there's an identifiable pattern that we can give you, Christian, but we do know that some usage patterns among clinicians are sort of idiosyncratic to the individual, and that if they have identified that this is what they even though the test can be used, you know, to rule out patients, to resolve diagnostic dilemmas, and to monitor patients, they may only see a utility for their personal practice in one of those or a subset of those. You know, those patients are all important to us because we believe we can convert them to greater context of use with type expansion over time.
It may be that they have a view that this is where the highest utility for biomarkers are, and that's all they use it for. That does happen.
Okay. I mean, given that I mean, when you look at the graph, there's not really too much. You can't really tell that sort of attitude is changing. I mean, how do you actually convert those people to use it for more than, you know, just those unique cases?
Yeah. I mean, that is the opportunity ahead of us. You've outlined why we consider that to be an opportunity. There are large numbers of clinicians that are already using our product, and they're not using it to the full potential. That is an area in which our sales team are, you know, they're already focusing.
There's another reason why we think it's important to have a broader sales force with different functions, so we can increase the number of touch points with either strategic account selling, if it is a strategic account that's ordering this way, or with a medical affairs team who may work with that particular account to try to enroll patients in a clinical study and gain traction that way, with a virtual selling team who may offer additional touch points, and then all of the stickiness initiatives that I mentioned before.
Again, just trying to make it easier for them to A, order the test, and B, once they have ordered the test, to stay a loyal customer who's ordering it recurringly on all patients that fit the context of use.
Okay. Cool. Thank you. I mean, so earlier in the deck, it says that over 2,000 urologists have used it. Combining those two sort of different sets, there's 1,500 urologists that have used it but haven't signed up. What's stopping them from signing up?
I'm not quite sure what you mean by signing up. I think you're referring to the difference between, you know, the number of monthly ordering clinicians and the total number of clinicians that have ordered through the year, total number of urologists that have ordered through the year. Yes, this does suggest that there are some individuals that don't order every month. That could be a function of the size of their practice. It could be a function of a number of different things.
Again, we see that as an opportunity because if we can continue to educate them on not just the use of the product as it is, as they are using it today, but for additional context of use, you know, by, you know, either showing them more clinical studies, evidence or involving them in clinical studies, you know, that medical affairs education program, you know, we believe can help turn 500 users a month into a higher number, knowing that 2,000 unique clinicians are already aware and ordering our tests in any given year. That's an opportunity for growth for us.
Thanks, Christian. We just got one last question come in, and that is from Daryl. Do you have sufficient testing capability to meet expected demand in the next 2-3 years?
That's actually a relatively easy one for us to answer. We do. I think we have a testing capacity of 300,000 tests per year in the United States. We're obviously just doing around 10% of that at the moment. I mean, there are other ways that you can increase you know, the throughput capacity of the lab. You could opt and any of these could be the right solution, and I would let the people on the ground make the decision. You could increase the number of shifts that we ask people to work. You could increase the number of days of the week that we operate. You could increase the number of instruments and greater footprint.
All of those things are, you know, fairly standard operations. We don't believe that there is any issue with scaling to meet demand, now or in the future.
Great. Thank you. That's the end of the questions and actually the end of the time.
Thank you, Grant, for keeping up with the time. Thank you everyone for your questions.
Over to you, operator.
Thank you. That concludes today's call. Thank you for your participation. You may now disconnect.