Good morning, everybody. Welcome to Pacific Edge's FY 2026 financial results. I'm Dr. Peter Meintjes, Chief Executive Officer. With me is Grant Gibson, Chief Financial Officer. Available later for questions will be Simon Flood, the Chair of Pacific Edge. Just want to remind everybody, there is an important notice and disclaimer about the information that we are presenting today. To move quickly through to our financial results, what we expect that you will notice that these fully audited financial results are not particularly different from the results that we published early on May 11. I will take the opportunity to move relatively quickly through this. We have 24,190 global tests, 18,783 commercial tests, NZD 11.5 million in operating revenue, which is down substantially as a consequence of the prior Medicare non-coverage, a net loss after tax of NZD 35.8 million.
Importantly, we worked very hard on our cash burn in the second half and had that at NZD 2.4 million per month for the second half, compared to NZD 3.3 million in the first half. As a reminder, our tests, Cxbladder Triage, Detect, Triage Plus, are used to risk stratify patients in the hematuria evaluation setting. Our other products, Cxbladder Monitor and Surveillance Plus, are used after therapeutic intervention on patients who have non-muscle invasive bladder cancer for the surveillance of those patients for recurrence. When used appropriately on the right patient populations, Cxbladder tests drive economic value for patients, hospitals, and payers. This is a key part of our message.
On the left, you can see that the incidence of cancer in hematuria patients is low, consequently, the current standard of care using cystoscopies only means that 100 patients will have to have 100 cystoscopies to find five cancers. We have a better alternative that shows that 85% of those patients when using Triage Plus based on its performance characteristics, 85% of those patients can safely avoid a cystoscopy, 15% will still need one, and of those, we will find the same five cancers. Cxbladder avoids invasive, unnecessary procedures for patients, driving down costs for health systems and payers. At scale, Cxbladder can spare more than 1.5 million patients in the U.S. from cystoscopy and save greater than $500 per patient. That information is from our budget impact model. Importantly, there are three high-level trends across the market.
The population in the U.S. is aging, and with an increasing number of patients requiring urology care as they age. Importantly, the number of urologists is falling. We're not training enough in the United States. The combination of those two things is quite likely to lead to delay in diagnosis for patients as wait lists get longer and longer. Importantly also, Medicare reimbursement for cystoscopy has been declining for a number of years and is likely to continue to decline. That creates additional drivers for urologists to spend their time on other procedures and to have fewer patients incurring a cystoscopy. Our product development approach is to drive strategic value through innovation, and our next-generation tests do exactly this. We are at an important inflection point, particularly since Triage Plus has also been covered recently in the draft coverage policy established by Novitas, which is a fantastic result.
We've been in the process of moving from Triage to Triage Plus. Triage Plus has been successfully analytically validated and clinically validated. That information was available to Novitas. They have made a decision to cover the test on that basis. The price has already been established by Medicare's pricing system at $1,328 per test. That dramatically changes the economics of operating our sales force and account executive, and that underpins the future profitability of the company. We have made Triage Plus available as an option to all physicians and clinicians who currently order our test. Our prior position has been that Triage Plus is available under early access. Early access really was a limited number of customers. Our change since receiving coverage has been that we will now allow any customer to order it.
We have many systems we need to build for handling Triage Plus volume, both in our lab and operations that are outside our lab, before we can fully launch that product and encourage and scale Triage Plus. At the moment, it is an opt-in for our customer base. We were seeking to have Triage added to the microhematuria guideline alongside Triage in FY 2027. That may no longer be possible. We have received information that the next update will only commence midway through 2027 at the earliest, the guideline may not be updated until closer to 2028. We also have a second product, as we reach various developmental milestones for Surveillance Plus, we will slowly be removing Monitor. Those steps are only in calendar 2027 and a long way ahead. Surveillance Plus is focused on multiple types of DNA marker, which is the innovation.
It uses a combination of SNVs and fragment lengths and other polymorphisms to create an interesting signal. Those publications are not expected until late FY 2027 or FY 2028. Surveillance Plus has completed the freedom to operate, and provisional patenting is progress. Our commercial target for Surveillance Plus is to have a CPT code, a submission for a CPT code by December 9 in 2026. If that date is achieved, it rolls forward, and in about six months' time, we'll be able to be reimbursed on a claim-by-claim basis for that test because there is no final coverage determination for Surveillance Plus. If that date is not achieved, we will then have the opportunity to achieve it again in March as these submission dates are quarterly. Moving on.
The draft Medicare policy that Novitas has now developed was sparked by, triggered by an excellent contractor advisory committee that we had on February 19th. During that CAC, they noted strong clinical evidence supporting Cxbladder Triage and Triage Plus, and the panel supported the use of validated biomarkers for a range of different hematuria risk groups. Initial evaluation, reflex, adjunctive, repeat use, and as a non-invasive option to anyone declining it. There were a number of use cases, not all that are covered by the guidelines today that urologists made very clear are of interest to them. There were also a number of logistical and economic benefits that were communicated, from primary care use through to rural use using in-home sampling, and the prioritization of high-risk referrals, early detection to avoid more invasive disease, and improved care for women.
Many women having their UTI diagnosis conflated with the possibility of bladder cancer. Strong alignment that Cxbladder tests have robust evidence and clinical utility, with several experts explicitly appealing for Medicare reimbursement and broad access to improve standards of care, and a pathway to re-coverage, which is one of the things we'll talk about a bit more today. Novitas has now proposed a draft that includes coverage for Triage and Triage Plus. They have also confirmed in follow-up that hematuria test claims that are outside of the scope of genetic testing in oncology can be paid on a claim-by-claim basis. Pacific Edge has already begun submitting intermediate-risk patients with date of service after May 15 to Novitas to see if we will get paid. Novitas has issued the draft LCD. No other urine-based biomarkers are included in the draft coding article, creating a moat around our microhematuria business.
This is a very important development. There are legacy tests and generic codes that are non-covered for the purpose of ruling out cystoscopy in intermediate-risk patients. There are also four competing codes that have been given non-coverage after reviewing their evidence in the local coverage article as well. The inclusion of Triage Plus gives us an opportunity to shift our U.S. customers over to the higher-performing and higher-margin test. It does have a higher clinical utility and works on a broader range of patient types. Even though it is more expensive, the performance characteristics means it can reliably rule out a greater percentage of patients, particularly higher-risk microhematuria, and potentially even gross hematuria, but we're not yet after that and chasing that indication.
By ruling out a greater percentage of patients and a greater percentage of higher-risk patients, we are able to provide even more value to the system when modeled in a budget impact model, and that work is in process as well, and we will be publishing that soon. A 70% improvement, and a substantial improvement in margin and margin percentage over our legacy products, is what we can now look forward to as we migrate customers over to the $1,328 test, Triage Plus. The clear language in the LCD is another major highlight for us. The language is not ambiguous, and that is very, very important. We have never had this before. This is a huge achievement.
The language makes it easy for Medicare Advantage payers to pay us. They can look at the language themselves, they can go, "This patient is clearly eligible, we're going to pay for the test." It removes objections that we have historically got for Medicare Advantage patients. Similarly, commercial payers who can read the guideline, they can read the Medicare policy, even though they make independent decisions which tests to cover and which tests not to cover, they have fewer reasons to deny coverage at this point. They also have clear language that they can copy. We see that as a major benefit of having this published policy. Pacific Edge is seeking claim by claim reimbursement for Triage and Triage Plus, and has been advised by Novitas that products covered in the draft are eligible for that claim-by-claim reimbursement.
Mapping the recent events onto a timeline. 14th of May in the U.S. was when we were advised of the coverage policy. It was very early in the morning. I happened to be in the U.S. at that time, attending the AUA meeting in the following days. The notice and comment period starts on June 6th. Novitas is going to hold an open meeting on June 18. Pacific Edge intends to attend that open meeting. Pacific Edge will also speak with a number of key opinion leaders in industry to attend that meeting and give their views. The notice and comment period is open until the 18th of July. Then we enter another period of waiting, where it is a black box. Novitas controls the timeline.
Based on our prior estimates of when we would expect to get the policy finalized, approved by Medicare, and published, we expect that to happen before January 2027. It is important to acknowledge that Novitas could still retire this LCD. What we want to make clear for everyone is that no longer appears likely. They have definitive policy supported by the evidence, supported by the experts, and it's available for everyone to see. Talking a little bit more about the impact that Medicare coverage can have on U.S. commercial payers. Specifically, well, the U.S. commercial payers are the largest group as a group, but there are hundreds of thousands of commercial insurance plans that we would have to get coverage in. While it's the largest group, it is a complex landscape to try to navigate.
Medicare policy plays an important role in how those individual payers and plans will pay for tests, because Medicare policy essentially establishes it for a large number of these plans as no longer experimental and investigational. This larger opportunity is even more important for the patient type that we are currently pursuing. The patient type is intermediate risk microhematuria according to the policy, and all of the men that are in the intermediate risk category will have commercial insurance rather than Medicare insurance because they are under 60. Microhematuria patients skew younger with commercial health insurance, and thus represent most of the total serviceable market for hematuria evaluation in the current Medicare policy and in the current guidelines.
Final coverage policy from Medicare is expected to unlock revenue from commercial payers by removing a key reason that they could deny us as experimental investigational. They can no longer do that. Providing additional evidence to overturn denials on appeal. Some might still try, but then as we appeal through their market access teams, we can still get paid. Providing language that commercial payers can adopt in their own policies, I mentioned that earlier. Leveraging state biomarker laws to mandate payment from commercial payers. We can also remind them, in the states where these laws have been passed, that they are expected to pay by law for tests that are also covered by Medicare. We focus on establishing medical policy directly with payers, or through third parties like Avalon, EviCore, Carelon, Concert Genetics, and ECRI. We already have positive reviews from Avalon and ECRI.
Trying to summarize some of that in the next slide here. Back in 2020, we actually had our first payer coverage of a sort. It was a letter of agreement between us and Kaiser Permanente where they approved commercial payment for Cxbladder tests. Subsequently, we published on our preferred, sorry, our improved test, Triage Plus, in December 2022. We've had an EMR integration go live in Kaiser Permanente. We've then, in May 2024, we've had STRATA on the podium at AUA, and from there, because STRATA was a randomized controlled trial, what we've been highlighting for investors for some years is that this starts the march forward for commercial payers to adopt policy or all payers to adopt policy, and aided by having a Medicare local coverage determination as well. In April 2025, we had ECRI giving us a four out of five.
I'm not sure that I've elaborated on this previously, but four out of five is a very, very high rating on the ECRI website, and many other comparable diagnostic testing services in the U.S. only have a three. Those that have a four include Oncotype DX Breast and Cologuard, and a couple of others. That's to highlight that that ECRI four out of five is very significant for us to have for Triage. It has also helped us, the randomized controlled trial, has helped us to get policy with Avalon Healthcare, and then the one-two punch from the randomized controlled trial is developing guidelines. With the guidelines, with ECRI, with Avalon, and with the CAC February 2026, and with Medicare coverage as of two weeks ago now or 10 days ago now, we are in a position where the dominoes are starting to fall.
It is very challenging for Pacific Edge to predict how quickly, but what we want to highlight for investors is that we did the work on making sure that we have very good quality evidence because this is how you underpin your future commercial success. These are just the policies we know about. Sometimes it's not public information or that we can easily determine, but we do our best to show how many lives are now covered for Triage and how many are covered for Monitor. All right. Moving forward, our largest customer and largest payer is Kaiser Permanente, and we want to highlight the importance of that partnership. I did get to celebrate at the AUA meeting with some of the members of KP that we work closely with.
Some of them also have senior roles in the American Urological Association, and the AUA were instrumental in submitting their own reconsideration request and working with Novitas to help raise the profile and importance of hematuria evaluation as a policy. What we want to highlight here is the importance of not just the commercial side of the business, but also how we have an enduring collaboration with Kaiser Permanente, particularly the group in Southern California, where we have performed the largest ever clinical trial of a urine-based biomarker for hematuria evaluation with 3,353 risk match patients. That's over 6,700 patients total in the study. That kind of evidence is things that is very difficult for payers to refute. Not only we've got the full house of clinical evidence.
The AV, the CV, the CU from a randomized controlled trial, and the CU from a real world evidence study. While we have achieved a very important milestone, and we do expect of ourselves to focus on commercial metrics as we chart a path towards profitability, it is important to know that our evidence generation is not finished. We have a number of publications that are coming up in the coming quarters through FY 2027, and we expect the STRATA second publication to deliver the AUSSIE clinical validation study to deliver. Those are clinical utility of Triage Plus, and the clinical validation of Triage Plus. The other studies won't result in the next financial year, but pretty soon thereafter, we have a number of studies that we also expect to resolve.
Our independent studies are also very important to us, and they provide us with the opportunity to explore new indications in a very low-cost way. The partner at the independent study does all the work. They do all the science. We provide free testing, and it's a way for us to work closely with the key opinion leaders in a way that's meaningful for them and for us, and stay in the headlines at conferences to make sure that we can become de facto the standard of care through being front and center in the activities that they hold important. We do have two that we are expecting in the upcoming quarters. 1 that has been submitted, and we're just waiting on that to publish, and that is our patient preference and satisfaction of biomarkers versus cystoscopy.
While this is obvious to almost anyone who's given it a fleeting consideration that a biomarker might be preferred as a non-invasive option over having a cystoscope shoved up your urethra, no one has actually documented that. While also taking into account the performance of the test. If your test doesn't perform well, your patient may have ongoing anxiety about did that test actually find the cancer or could it have missed the cancer? A very important study done entirely independently coming up. All right. The FY 2026 volumes have fallen. This is a trend that we will be looking to start to reverse with all of the tailwinds that we now have across our business.
It's important to remember that actually in APAC, the volumes were steadily increasing the entire time, that it is really only the consequence of the Medicare non-coverage and the smaller sales team that we've had over there. These have been the drivers behind our reductions. As we are able to act on the tailwinds that we have, putting more resource behind commercial scaling, we expect to be able to grow our volumes. Our U.S. operations have faced a number of challenges. This has been a common theme. The disruption of transitioning U.S. customers from Cxbladder Detect to Triage after non-coverage was a big effect on our financial results. The post-balance date results notwithstanding, last year was a challenging year, and we have a smaller sales force that's been trying to deliver for us as a business. All right.
Highlighting where we have some strategic wins, across the entire Asia-Pacific region, we are charting a path towards profitability, and this is the key message we want you to take away. The APAC commercial and clinical operations, when you exclude the R&D cost, is trending towards profitability on a direct cost basis with an FY 2026 cash burn of NZD 0.6 million. We are aiming to close that as much as possible over the next 12 months. We'll report on that in our half-year results as to how well we're doing. That was at least in part fueled by repricing efforts to bring our tests in line with market expectations. Going forward, it'll be fueled by a wider adoption of Triage Plus over the legacy products which we'll be promoting throughout the Asia-Pacific region. In New Zealand, we know that we're in the closing stages of a national pathway.
We expect to hear from them prior to July, but at this stage, we don't know whether we've been accepted or not. We continue to push for that, working closely with the Urology Council and with Te Whatu Ora. In Australia, we're focused on hospital contracting, and until we have a simplified IVD that we can run in Australia, that will be our main go-to-market option. When we have an IVD that can be run in Australia, we can attempt MSAC reimbursement. In Asia, no new milestones in the last couple of weeks, but we're continuing to grow that area. We're processing samples, commercial samples from seven markets, selling either directly or through a distributor lab partner, and continuing to try to get as much as we can from the pathways that we have already implemented, specifically in Singapore General Hospital.
I'm going to move to Grant, who's going to talk about the financial performance.
Thanks, Peter. As Peter's mentioned, our operating revenue fell by 47.4% on FY 2025. That was predominantly due to the loss of Medicare coverage, which impacted both volumes and the price we received per test. We also reverted to cash accounting for Medicare revenue in the current financial year, which impacted our current year. We have focused strongly on reducing operating expenses. You're seeing income down 9.5% on FY 2025. In second half of 2026, we're down 11.9% on the first half of the current financial year. We focused on cash preservation, where we made sure that we maintained a market presence that positioned us for the company regaining Medicare coverage. We've also seen focus with the net cash flows and operating activities down 32.1% for the second half of the financial year compared to the first half.
Net cash at the end of the financial year was NZD 7.8 million. That has been increased with the successful completion of the NZD 25.4 million placement, which settled on the 15th of May. It is also worth noting that we do have a share purchase plan that is currently open for shareholders with a New Zealand address and hold shares on the 8th of May 2026. This closes on Friday the 28th of May. I will point you to the release we made this morning on the NZX and ASX platforms. That provides an update on the process. We were targeting NZD 6 million in the placement. As of this morning, we have had confirmed interest of NZD 14 million in applications.
While we still haven't made any decision as to the acceptance of oversubscriptions. We will note that when the retail offer is closed, based on the level of acceptances received to date, the board considers it likely that scaling of applications will be required. Any scaling will be made by reference to the number of shares held by eligible investors at the record date, which was eighth of May. As we look at operating expenses. Next slide, please. Cool, sorry on that. Thanks. This has been a focus for the year with a reduction of 9.5% year-over-year. If we look at the individual categories, lab operational expenses are down, as you would expect, with reduced volume through our U.S. lab in particular. Research is down 8.2% on FY 2025, and that has been largely impacted by reduced clinical study costs.
The cost for clinical studies are largely forward-weighted. As studies have come to completion or nearing completion, we've seen some expense savings in that category. Sales and marketing has been the largest impact, as we've reduced our frontline sales staff. We have reduced expenses in sales and marketing area by 20%, second half versus first half, and we're down 13.2% year-on-year. Our general and admin costs are also down as we focus on cash preservation. Thank you, Peter.
Thank you, Grant. Just moving ahead to the outlook slides. The recent events have been very important. We are positioned to unlock the value through upcoming commercial, clinical, and innovation milestones. We've been waiting for this for a long time. We have an opportunity that we can get claim-by-claim revenue coming in now. This draft LCD has proposed coverage for Triage and Triage Plus for intermediate-risk microhematuria patients, so that's where we will be focusing. Claim-by-claim reimbursement for Triage and Triage Plus for intermediate-risk microhematuria payment is in alignment with the draft LCD. It is something Novitas has advised us we can submit for payment. Progressively phasing in Triage Plus at $1,328 to U.S. customers accelerates our path to profitability while saving costs for healthcare systems. This is very important. Advancing medical policy for Triage with commercial payers, leveraging the draft LCD, the AUA Guideline, ECRI, review, and Avalon policy.
All of those things are the dominoes we already have that have fallen, and we expect more to come in the coming months and quarters. Cxbladder is under consideration by Health New Zealand for a national pathway in FY 2027. We expect news relatively soon.
In the medium term, we drive value for the business using clinical evidence development. The DRIVE publication supported Triage Plus validity. We are awaiting an updated literature review by the AUA for subsequent guideline inclusion. As mentioned, that's not proposed to start until June 2027, as we understand it. Kaiser Permanente study shows real-world evidence for Triage in the largest urine-based biomarker study of hematuria patients. Our evidence generation program continues, because to make something the standard of care, you kind of never need to stop generating evidence. Triage Plus still needs its randomized controlled trial to be able to change the game all over again.
The draft LCD and a number of other events have created the precedent for turning Cxbladder evidence into robust medical policy. We are already seeing the evidence with Blue Cross Blue Shield of North Carolina, South Carolina, Kansas City, and Centura already adopting that medical policy. Innovation drives our long-term value creation. The next-generation products are positioning ourselves very well. They have superior performance, and that underpins their application in a broader range of clinical indications, improved patient experience, and greater cost savings for healthcare systems. For Pacific Edge, we of course have the benefit of improved unit economics. With Surveillance Plus, we are targeting a CPT PLA coding submission for December, where we can then expect revenue on a claim-by-claim basis after July 1, 2027.
We are seeking an NZD 1,800 price for Surveillance Plus with provisional local pricing from Novitas, with final pricing to be determined by a crosswalk during FY 2028. Ongoing investment in product simplification and kitted IVD products to enable decentralized international development is another area for long-term value creation through innovation. With that, I'm going to pause for questions, and I believe we have some people, but I'll turn over to the MUFG folks to guide us through that.
Thank you. We will now begin the Q&A session. For those listening by phone and would like to ask a question, please press star followed by one on your telephone keypad to raise your hand and join the queue. To withdraw your question, simply press star one again. When called upon, please use your handset or headset and ensure your line is unmuted and be ready to ask your question. Today we kindly ask that you limit your questions to two per person so we can accommodate as many participants as possible. Your first question comes from the line of Rob Morrison of Craigs Investment Partners. Please go ahead.
Hey morning, guys. It's a great outcome, and stoked to see it, and really good on you and the wider team for sticking with it during what must have been some pretty challenging times.
Thanks, Rob. Appreciate it.
No worries. First question on the monthly cash burn. You have this target for FY 2027 of NZD 2.5 million per month, and I see you've basically kept that in place, following getting Medicare coverage or draft coverage. Is the way to look at that you have this NZD 2.5 million target for, and the revenue will be higher, but offsetting that pretty much exactly the OpEx will be higher to support the ramp?
Look, that's what you can conclude at this stage. We do expect of ourselves, as a board and a management team, to have a strategy session at some point to evaluate whether that is what we want to do. There's more evidence that we have to gather before we can commit to forward-looking scaling. What we need to do is we need to make sure that we can successfully run Triage Plus tests at scale by opening it up to a broader number of customers, as we have done. We need to show that those elements are working. We need to determine an official launch date by which we would start to move everybody over, sort of with a bit more force behind it from Triage to Triage Plus.
We also need to show that we are getting the right kind of profitability and the right kind of volume with the restrictions that we have of accepting only intermediate-risk patients. That's going to be very important for part of our operating environment. As we can demonstrate those to ourselves, we would then look to reevaluate how quickly we can scale and whether or not changes in burn rate are justified. At this stage, your high-level conclusion is accurate.
That's great. Thank you. Appreciate it's early days, but are there any thoughts on when you'll hit free cash flow breakeven? Is that kind of a very near-term thing or a bit further out?
Look, we know what that can look like based on volume. What we have to do is prove to ourselves that we are bringing in that volume and at an acceptable level of unit economics for the sales reps. We've modeled scenarios that get us there, but we need to see it in execution first. We need to be managing the business that way.
Okay. That's fair enough. Final question from me, if I may. It's a pretty big market opportunity, $7 billion in the U.S. Can you give me a rough sense on what a successful timeline to penetration would look like?
Sorry, Rob, the sound wasn't all that clear.
Timeline to penetration.
Timeline to penetration. At this stage, look, we don't want to give any definitive timelines. Like I said, we've got to prove some of the fundamentals to ourselves that, yes, it is a very large market, but we're also changing the behavior of physicians, and we are going to be selling our test in a way that we haven't been selling it before, right? Historically, we have been selling Triage and Detect for any hematuria patient. Right now, we will be selling very strictly in accordance with the guidelines. We'll be selling intermediate risk only, and we have to make sure that we are effective at that. As and when we are effective at that, and that is still a very large market, right?
It's narrow indication, but it's a narrow indication of the large market, but it is a subtly different way that we have to sell. As and when we do that successfully, and we know that we've got that commercial model working, we can probably give you more insight into how quickly we can penetrate things. One other thing I'll add to that is, and because we're probably going to get a question from someone about it, is we believe our tests do work in low-risk hematuria patients, intermediate-risk hematuria patients, and high-risk microhematuria patients. We believe they work in all three of those. As a consequence, while we deeply appreciate that Novitas has developed policy, and in the context of LCDs, this has been policy that has been drafted very quickly, and we appreciate all of that.
It is important for us to also push back on Novitas and say, "Hey, the guidelines might say intermediate-risk patients." The guidelines were actually. They stopped reviewing evidence in May 2024, and the world has moved on from there. Most importantly, it has moved on from there with an analytically validated and a clinically validated of Triage Plus and a real-world evidence study for Triage that shows using it in low, intermediate, and high-risk microhematuria patients. That's the way to change the indication. Using the test outside of the indication is not smart when you have a very clear indication, and so we won't be doing that. We will be doing, on the basis of any new piece of evidence, we will be asking Novitas to consider that evidence as a reason to change the patients that are indicated for coverage.
Okay, that's helpful. I'll let someone else have a go, but really, congratulations and very well deserved. Thank you.
Thank you, Rob.
Before we move on to the next question, a reminder, if you would like to join the queue, to press star 1 now. Your next question comes from the line of Ben Crozier of Forsyth Barr. Your line is open.
Morning, guys. Wondering if you can touch a wee bit on the growth in either revenue or test volumes from the sort of non-CMS part of the U.S. business. Kaiser Permanente and the remainder of those private payers. What sort of growth did you achieve in FY 2026?
Well, Ben, that is a very good question. We don't want to single out any one customer like Kaiser Permanente, so commenting on them on their own, we try to avoid doing. We do want everybody to know that the Kaiser opportunity is performing in line with expectations for the current indication that they are using it for, which is actually slightly different from the AUA guidelines. It's on slightly lower risk patients, et cetera. They are using it optimally in their system, and they are growing accordingly. I don't have numbers to hand on what the growth in the commercial overall is, but it is worth noting another couple of points. The volume is one thing to grow. You also have to get paid on all the tests. With the commercial payers, the paid amount that we get is actually higher than NZD 760.
We don't get paid on every test, and that's often difficult for folks to understand. We do expect that to change now that we are in guidelines and have Medicare coverage. They've essentially got fewer reasons to not pay for our tests. Commercial payers will do everything they can to not pay for the test. That's why things like state biomarker laws have been brought in. We have more aggressive ways of chasing them now than we ever have had. We expect what's called our success percentage for those initial claims and for the subsequent appeals to increase. As an anecdote, there is something that we've told the market about before.
You can take a commercial insurance company to what's called external review, which is where they get a panel of experts, and they get paid $2,000 to be there to provide their opinion on whether or not a test is medically reasonable and necessary and should be paid. We have had one of one actually happen because there's a long lag between when we run the test and when we can get through the appeals process, through to external review. We have been paid on that test. We expect, as part of our revenue cycle management and billing processes, to be aggressive because we have the evidence behind us, and we want to go after those payments. It is a long time to change that market. Look, I hope I haven't been too obfuscatory in answering your question. I don't intend to be.
It is a complicated thing to answer.
Yeah. No, that's some good color. Thank you. Maybe just on what proportion of your test volumes actually fall into this intermediate risk category today?
We have not disclosed that figure, and I would elect not to disclose the figure just as a Q&A here. You can use some basic prevalence for bladder cancer to give yourself an estimate of it. Bladder cancer is disproportionately something for older people, Medicare-aged. Hematuria is younger, but we have predominantly been targeting a population of patients that are higher risk, gross hematuria, and so our population has been more biased towards Medicare and therefore not intermediate risk patients previously. We have some work to do to make sure that we are targeting the right patient types with this very clear indication from MolDX and very clear indication from the guidelines.
Yeah. No, that's all from me. Thank you.
That concludes our Q&A session on the phone. I'd like to hand back to management.
Great. Thank you. We have some come in online. Okay. The first one, I think you probably answered it, just wanted to see whether you had anything else. It comes from Andrew, and it focuses on the commercial team now focusing on commercial payers instead of focusing solely on CMS. Am I correct in this understanding, and what impact will that have on revenue?
The way we structure our commercial team is that there is sales, marketing, and market access, and reimbursement is a third discipline. It is also true that sales and marketing have been able to focus on Medicare Advantage, that they actually do not think about the insurance nature of the patients that they are going after. They should be thinking about the patient based on their clinical criteria. Is that patient intermediate risk? Yes, go after them. Whereas our market access team has absolutely been heavily focused on Medicare. But again, I do not mean to be too candid with my answer, but if that was the only thing we were focused on, that is not a full-time job, right? They have been focused on the Medicare as number one priority, but they have been focused on a number of other things as second, third, fourth priorities.
That is why we have had Blue Cross Blue Shield GPO wins. That's why we have had policy with Avalon and Anthem. That team is very busy. We have also been in the background trying to appeal the Medicare denials through the Medicare appeals process on the basis that they are medically reasonable and necessary, and that is another activity for that team. The sales and marketing team, they will have to refine their strategy to sell to intermediate-risk patients. The market access team, who deal with the insurance companies, they will have to put less work behind Medicare now on the front end, we will have to adapt our billing processes to make sure that we can handle the new environment. There's a lot of work to be done there too.
Great. Thanks, Peter. The Novitas meeting that is open for discussing the LCDs on Thursday the 18th of June, is it possible for Pacific Edge shareholders to listen in to this meeting?
The short answer to the question is yes. These are very dull meetings, though, and I don't think that that is good use of investors' time. It's up to you to disagree with me, though. They typically run from around 1:00 a.m. until about 7:00 a.m. , so they are not in a suitable time zone. To find the dial-in details, you have to use a VPN to access them on the Novitas website. We will have people on the calls. I have attended one or two of these meetings. We may try to make those details available if it is of interest to investors. 95% of the call will be not Pacific Edge related.
All right. Thank you. Have there been any approaches by acquirers? Pacific Edge would be the perfect bolt for a U.S. big pharma.
No comment. I would be bound by confidentiality on that. I maintain, as a program of work, relationships with people in business development at large companies and CEOs of similarly sized but more commercially advanced companies within the diagnostics and therapeutics space and as part of my conference activities throughout the year. That's probably about the only color I think I can meaningfully give to that.
Great. Thanks. Another question from Andrew: Why is the Medicare price for cystoscopy falling?
I guess I don't know a concrete answer for that, but I guess they are viewed as not adding sufficient clinical value by Medicare when Medicare reviews it, and as a consequence, they lower the rate. They want you to be doing something else with your time, so they incentivize you appropriately. It's not unusual for prices within the Medicare system to come down. It's actually one of the reasons why there are lobbying groups, for example, like LUGPA. They're predominantly a lobbying association for large urology group practices. They try to keep cystoscopy rates high so that physicians can generate more revenue from them. Medicare, overall, if they can lower the price on something, they will.
Unless there's huge pushback from an agency that can be justified, or sorry, by an advocacy group that's justified, you should expect the price of things to go down.
Great. This one I might direct to Simon Flood, who's our company chair. With the retail offer scaling, would you consider scaling based on time the shares have been held?
Thank you, Grant, I think the person who put that in said that they were a long-suffering shareholder of Pacific Edge, so look, first and foremost, I just want to thank the person who put that question forward for, A, asking a question, but B, for sticking with Pacific Edge for as long as they have. To answer your question directly, look, we, in making allocations, are guided by New Zealand Stock Exchange rules. The rules insist, and understandably so, that you create a level playing field where all shareholders are treated consistently and fairly, and the board will be guided by that.
I think the rule that we are following, and we've said this in the retail offer documents, is that what we will be guided by is the number of shares that people held at the record date, which I think, Grant, was 8th of May. Yeah?
Great.
Yeah.
Great. Thank you. Okay, this question from Adrian. Is the end of the notice and comment period for the draft LCD the logical milestone to reconsider ramping up the U.S. sales force, particularly now you have taken over subs on equity raise? I think you've actually covered that. Was there anything else that you wanted to talk about, what you need to see before we start scaling?
Before we start scaling. Look, I did a fairly extended, painted a picture there earlier in the presentation. Look, it's not tied to the end of the notice and comment period at all. It is tied to the evidence that the things that we need to prove to ourselves internally that we are ready to scale. That revolves around making sure that we've got robust processes around processing intermediate-risk patients, robust processes around processing Triage Plus tests, and the ability to migrate every hematuria test over to Triage Plus. It is about demonstrating to our satisfaction that we have the unit economics that we have talked about since trying to get that price for Triage Plus. When we can demonstrate those things satisfactory to ourselves, that will be the signal that we can be more aggressive. I hope that answers your question.
Great. Thank you. There was only one other question, AJ, but I think that was answered earlier in the presentation as well. That brings to a close the questions.
Awesome. Thank you everyone.