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PACIFIC EDGE LTD (PEB) - How Pacific Edge Is Rewriting Bladder Cancer Diagnostics With Cxbladder And Triage Plus

• Andrew Musgrave

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A pee-in-a-cup that can change urology care might sound too simple, but that’s exactly the point. We sit down with Dr Peter Meintjes, CEO of Pacific Edge, to explore how Cxbladder turns a urine sample into decisive signals that help rule out bladder cancer, reduce invasive cystoscopies, and save health systems money without cutting corners on accuracy.

We walk through how the test works, why choosing RNA from urine is such a technical leap, and how a stabilising buffer keeps samples viable at room temperature for up to 11 days. Then we dig into Cxbladder Triage Plus, a multimodal upgrade that blends RNA and DNA with advanced algorithms. With stronger performance and a US Medicare price of USD 1,328, Triage Plus is positioned to deliver real-world savings by avoiding unnecessary scopes and scans while giving clinicians clearer answers for patients with hematuria.

Reimbursement drives adoption, so we unpack the pathway with Novitas, the Medicare contractor, following inclusion in the American Urological Association guideline. Peter explains the evidence framework—analytical validation, clinical validation, and clinical utility—that underpins coverage decisions, and why a new local coverage determination could reset the company’s US strategy. We also cover capital discipline after coverage loss, the send-out testing model across Australia and Southeast Asia, and the longer-term plan to simplify the assay into an IVD kit that partner labs can run closer to patients.

We close with a practical look ahead: restoring Medicare coverage, charting a return to profitable operations, and fully resourcing high-priority projects. If you care about cancer diagnostics, health economics, and how evidence shapes access, this conversation offers a clear map of the science, the policy, and the commercial levers at play. Enjoy the episode, share it with a colleague, and subscribe to get the latest updates—then tell us what part of this strategy you want to hear more about next.

Andrew Musgrave

Welcome to ASX Briefs, where we explore the companies making waves on the ASX. And today we're joined by Dr. Peter Meintjes, CEO of Pacific Edge Limited, a global cancer diagnostics company leading the way in urine-based geonomic biomarker tests for bladder cancer. 
 Peter, thanks for joining me today and welcome to the ASX Briefs podcast. 
 
 Peter Meintjes

Thanks very much for having me, Andrew. Delighted to be here. 
 
 Andrew Musgrave

Now, Peter, for listeners that are new to Pacific Edge, can you tell us about the company and what it does and what is Cxbladder?

Peter Meintjes

Yeah, sure. Pacific Edge is a New Zealand-based company with lab operations for our molecular diagnostic test space in Dunedin, New Zealand, and in Hershey in Pennsylvania in the United States. And our largest market for our products is the United States, of which we have two. Our two products are both involved in the care of bladder cancer patients and specifically what's called haematuria evaluation, which is if a patient has blood in the urine and a physician wants to determine whether or not that blood in the urine is actually a sign or a symptom of bladder cancer. And we have a product called Cxbladder triage that's used on those patients. And the second product that we have is used for patients who might have been unfortunate enough to actually get a diagnosis of bladder cancer, but fortunate enough that it is non-muscle invasive, which means it has not spread and it's localized. And if they have had that tumour removed, they then go on a surveillance regime. And that surveillance regime currently consists of repeated cystoscopies, which is a procedure that is somewhat invasive, sticking a camera up the urethra to determine if there is cancer on the bladder lining. And we offer a test in that space that allows them to not have to undergo those procedures unless there is a positive Cxbladder result.

Andrew Musgrave

Okay, and your suite of Cxbladder tests are at the core of your operation. So, what makes this diagnostic approach so unique compared to traditional methods?

 

Peter Meintjes

So, the broader category in which we have all of these tests is molecular diagnostics. And molecular diagnostics can use DNA or RNA or proteins and other similar compounds available in blood or urine or sputum or other sources to collect the sample. What makes our test special is that it is using RNA, which is inherently less stable than DNA, and it and they but to analyze RNA from a urine sample. And so, our patients, the only thing that they have to do is they have to pee in a cup, and at the site of collection, the urine is then stabilized so that we can later extract the RNA. And then we do that in our when we receive the sample in our lab and we have a buffer that keeps that sample stable at room temperature for up to 11 days. So, it's not just the method and the analysis that makes it unique, but it's also the buffer that allows an inherently stable analyte called RNA to remain stable at room temperature for 11 days so that we can ship it from anywhere on the planet to either Hershey, Pennsylvania, or Dunedin, New Zealand, so that we can analyze it. We also do have a next generation test coming out that has a few other unique features that are that are improvements over the current standard of care of our existing test as well.

Andrew Musgrave

Okay, and you've recently released data regarding your next generation product, Triage Plus. So, what do these findings show about its clinical and economic value?

Peter Meintjes

Yeah, so Triage Plus is what we call a multimodal test. And what it does is it uses RNA like its predecessor tests, but it also uses DNA. And so, it's using two different modes of detection for a signal. And those two signals are then complementary when kind of when you know extracted together and then analyzed separately and then coalesce together again using very advanced algorithms. So, that has helped it to be you know to vastly outperform our legacy products and any other competing products when we combine those two modes. At the same time, Triage Plus has been priced at $1,328 per test in the US Medicare system, and that's a substantial increase in pricing over the the existing price of $760 for our legacy products, and that creates a much higher path or a much more efficient path to profitability for us in terms of the underlying economics of what it means to operate a sales rep. Now we can basically bring in more revenue per sales rep than we were able to before. In terms of the cost to the system, it actually represents an even greater saving to the healthcare system despite the higher price, because it is we are able to rule out even more patients from needing unnecessary cystoscopies or imaging diagnostics. And so that actually results in an overall greater saving to the system despite the higher price.

Andrew Musgrave

Okay, and you've touched on Medicare. So, the biggest opportunity for the company is winning reimbursement for the tests in the US public healthcare system, which is Medicare. So, can you tell us about this opportunity?

Peter Meintjes

Yeah, absolutely. So, look, we follow a very relatively unique model where diagnostic tests run in a single lab, in a single location that provide their tests nationally, they actually have their Medicare coverage determined by what's called a local Medicare administrative contractor or a Mac. Our Mac in Pennsylvania is called Novitas. And Novitas have recently responded to the inclusion of Cxbladder triage in the AUA guideline. And the AUA is the American Urological Association who described the best practices that urologists should follow in their practice. And they have recently made an update to their guideline that includes Cxbladder triage. So Novitas, our Mac, has responded to that and has tentatively scheduled what's called a contractor advisory committee meeting. And that is scheduled for the 20th of February, Australia, New Zealand. And that kicks off a process where they were they are talking with key opinion leaders in the field to gather the state-of-the-art feedback of the latest products and the latest technology and the latest science. And then that only that meeting only lasts about an hour. And then after that, they have Novitas has what they need to begin drafting medical policy. That's called a local coverage determination. And that local coverage determination would then be drafted and published within the next three to five months, say. And at that point, when draft coverage has been proposed, that is when we would know the revised coverage status of our test.

Andrew Musgrave

So, how will you win coverage? What evidence does Medicare require from a diagnostic like yours? And how does your current evidence stack up?

Peter Meintjes

Fantastic question. Evidence coverage and guidelines inclusion underpin the commercial success of molecular diagnostic tests like ours. And we take that foundational principle into everything that we do at Pacific Edge. We generate our clinical evidence as part of an evidence development program in what we call the AVCVCU framework. That stands for analytical validation, clinical validation and clinical utility framework. Analytical validation is the first step. It basically just it's a publication that you need to put in the public domain that needs to be peer reviewed, that shows how your test performs under varying conditions and that it can produce repeatable, reproducible, reliable results. After that, you need to prove the clinical validation, which means you have to test it on a patient population that is not the same one that it was designed in. So, you run that on an independent cohort in a clinical validation study. And when you've done that, you've established the two major elements of the program. But you still have to, when you when you are trying to change the behaviours of physicians who have been trained a certain way for their entire life, or you're trying to change the way that a guideline committee makes its recommendations, you need to also describe the clinical utility of the test. And for that, you run a randomized controlled trial with a randomized arm and a control arm and show that when you use our test, in this case Cxbladder triage in a certain way, that it actually leads to different outcomes. And all of those, the AV, the C V and the CU, have all been done for Cxbladder triage, and that's how we got included in guidelines. We've also been recognized by a group called ECRI, the Emergency Care Research Institute, with a four out of five rating, who have looked at the evidence that's already available. And that essentially creates a template for what we expect Medicare would do when they go through their reconsideration process, which, as I mentioned before, kicks off with this contractor advisory committee that's scheduled for February.

Andrew Musgrave

Now, just looking at the financials’, operating revenue was down following the Medicare coverage loss, but you recently completed the capital raise. So how is Pacific Edge managing its capital to navigate this period?

Peter Meintjes

Pacific Edge is doing everything that it can to conserve capital in the operating environment in which we find ourselves, which is a challenging one given the non-coverage determination from Medicare that we had in April. But we have we've taken a prudent approach to the remaining capital while focusing on what we see as the unassailable strategic priorities, which of course is anything that is related to getting us recovered by Medicare. In answering one of the prior questions, you know, we now believe that we have done all of the things necessary for coverage. And so it is up to Medicare to follow their process until, and we don't control that timeline, but until they concluded that we will continue to manage our capital as prudently as we can.

 

Andrew Musgrave

Okay, now beyond the US Medicare market, where else do you see growth opportunities for Cxbladder?

Peter Meintjes

We do see growth opportunities in almost every market, but they're international markets require a different strategy. At the moment, we are seeding the market with kind of business development-like activities in Australia and Southeast Asia. We don't yet operate in Europe. And in all of those markets, we currently operate what's called a send-out testing model where those tests are sent to New Zealand, and we run them there. When we have so we have a program of work internally to simplify the test that we have so that it can actually be condensed down into what's called a kit, and then to have that kit something that could be run in any lab, in a partner lab um closer to where the customer is at. And at that point, the economics become slightly different, the turnaround times become slightly different, and the go-to-market model is slightly different because those partners will absorb some of the sales and marketing costs are associated with them. But we're not really able to enable that model yet until we have um simplified the product to the point that it can be turned into a kit and then taken that kit through an IVD process for most of the countries in which we would like to operate. So, when we've completed those investments, we expect to be able to grow in a larger number of markets.

Andrew Musgrave

Okay, and then other than CX bladder, are there any other tests that you have in the pipeline?

Peter Meintjes

So right now, we do not have anything else related to bladder cancer in the pipeline, and as we're focused on ensuring coverage for Cxbladder triage plus and um our newer product for the surveillance of bladder cancer surveillance plus, um, and then the IVD program of work that I've mentioned to simplify the test. So that's really where our RD is focused right now. But we do imagine a future further ahead than that, in which what we have built in terms of an evidence generation program can be expanded outside of bladder cancer, and it could be repeated in other urological cancers or gynaecological cancers, or really any other cancer in which we can identify what we call firstly an unmet clinical need, where we have a credible right to win that market based on the science and technology that we either currently have or could acquire and bring into the business. So that's how we will evaluate expanding beyond um the CX better tests we have today.

Andrew Musgrave

Okay, now just to wrap things up, looking out 12 months, what are some of the key milestones that you're looking to achieve in that period?

Peter Meintjes

So, look, it's always a little hard because we don't give forward-looking guidance as a business, but the milestones that we would like to uh to cross off are number one, um Medicare coverage. So, re-establishing that um with a local coverage determination, which will be different from the previous reliable reimbursement that we had because there will actually be language in an LCD. The other, assuming that we can complete that early enough in the next 12 months, that puts us on a really good trajectory towards profitable operations. And it's long been a goal for  for us as a company, and it's something our investors are very keen to see that we can demonstrate that we as a business can operate profitably. At that point, we actually imagine our investors would want us to still continue to grow at the maximum rate, but to be able to demonstrate profitable operations is something that we would like to achieve. And as we have more capital available, what we would like to be able to do is fully resource all of our high priority projects. There's a number of things that we have identified as being high priority, but that we simply haven't had the resources to execute on given the capital constraints that we're currently operating under, and to be able to fully resource those high priority projects would be uh an absolute delight if we're able to achieve that in the next 12 months.

Andrew Musgrave

Okay, Peter. Well, it's been great to chat today to get an update on where the company is at. So, we wish you all the best and look forward to further updates from Pacific Edge in the upcoming months.

Peter Meintjes

Thank you very much, Andrew. Appreciate your time.

Andrew Musgrave

That concludes this episode of ASX Briefs. Don't forget to subscribe, and we look forward to catching you on our next episode.