Q4 25 Cxbladder Volumes Rise and Key Metrics Improve

4 April 2025


Q4 25 CXBLADDER VOLUMES RISE AND KEY METRICS IMPROVE
Pacific Edge sees lift in number of US clinicians ordering Cxbladder and number of tests
ordered per clinician

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today
announces tests processed at its laboratories in Q4 25 improved 6.8% on the prior quarter (Q3
25), lifted by increased adoption in the US.
Total laboratory throughput (TLT) in Q4 25 rose to 7,577 tests from 7,092 tests in Q3 25.
Q4 25 US TLT was 6,490 tests up 11.7% from the 5,808 tests in Q3 25, lifted by an increase
in the number of unique US ordering clinicians to 914 from 866
1
in Q3 25 and an increase in
the number of tests each US clinician orders to 7.1 from 6.7
1
in Q3 25. The US volume lift
follows continuing incremental improvements in sales force efficiency, up to 406 tests per sales
FTE from 379 tests in Q3 25, and a seasonal post-holiday rebound.
The American Urological Association’s (AUA) February 2025 inclusion of Cxbladder Triage
with a ‘Grade A’
2
evidence rating in its new microhematuria guideline has changed our sales
pitch to clinicians, medical policy makers and healthcare payers, and generated renewed
interest in Cxbladder among the broader urology customer base.
The longer-term impact of this change may take some time to affect the daily lab throughput
figures, and as we await various coverage-related events, our commercial team will focus on
profitability per sales resource in the wake of the guideline update before seeking to expand
the size of the team. Further commentary on the implications of this guideline for Pacific Edge
are detailed in the investor update released today.
Q4 25 Asia Pacific TLT was 1,087 tests down 15% on the 1,284 tests in Q3 25, with the
decrease partly reflecting a reduction in evaluation and clinical study volumes as we continue
to focus on commercial testing volumes and see the impact of budgetary constraints within
some Health New Zealand – Te Whatu Ora regions.
Total volumes for the year to the end of March 2025 (FY 25) were down 11.5% to 28,894 tests
from 32,633 in FY 24, with the fall reflecting the reduction in the sales force compared to the
prior financial year in response to the uncertainty over Medicare coverage of Cxbladder.
In addition to the commentary on the guideline, the Q4 25 investor update also provides:

1
The number of ordering clinicians in Q3 25 and the tests per ordering clinician has been restated to
reflect post period adjustments.
2
The AUA defines ‘Grade A’ evidence as evidence with a high certainty rating and notes evidence of
this grade makes it "very confident that the true effect lies close to that of the estimate of the effect".

- An overview of the new evidence demonstrating the clinical utility of Cxbladder Monitor
in the surveillance for the recurrence of bladder cancer and the cost savings it delivers
to healthcare payers.
- Our formal rebuttal of the evidentiary review of ‘Genetic Testing in Oncology: Specific
Tests’ (L39365) Local Coverage Determination released on 9 January 2025.
- Advances in our clinical evidence generation program and how the AUA guideline
inclusion has further validated the role our clinical science team plays in creating
shareholder value.

Released for an on behalf of Pacific Edge by Grant Gibson, Chief Financial Officer.
For more information:
Investors: Media:
Dr Peter Meintjes Richard Inder
Chief Executive The Project
Pacific Edge P: +64 21 645 643
P: 022 032 1263
OVERVIEW
Pacific Edge: www.pacificedgedx.com
Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way
in the development and commercialization of bladder cancer diagnostic and prognostic tests
for patients presenting with hematuria or surveillance of recurrent disease. Headquartered in
Dunedin, New Zealand, the company provides its suite of Cxbladder tests globally through its
wholly owned, and CLIA certified, laboratories in New Zealand and the USA.
Cxbladder: www.cxbladder.com
Cxbladder is a urine-based genomic biomarker test optimized for the detection and surveillance
of bladder cancer. The Cxbladder evidence portfolio developed over the past 14 years includes
more than 20 peer reviewed publications for primary detection, surveillance, adjudication of
atypical urine cytology and equivocal cystoscopy. Cxbladder is the focal point of numerous
ongoing and planned clinical studies to generate an ever-increasing body of clinical utility
evidence supporting adoption and use in the clinic to improve patient health outcomes.
Cxbladder has been trusted by over 4,400 US urologists in the diagnosis and management of
more than 100,000 patients, including the option for in-home sample collection. In New
Zealand, Cxbladder is accessible to 75% of the population via public healthcare and all
residents have the option of buying the test online.

---

APRIL 2025
INVESTOR UPDATE
INSIDE
Letter from the CEO 2
Q4 25 test volumes 3
AUA Guideline supportive of
commercial operations 5
Guideline features at SESAUA
Meeting 6
Rebutting Novitas’ evidentiary
review 6
Monitor gets support in Australia 7
Clinical study program update 9

Dear Shareholders,
The American Urological Association’s (AUA)
2025 amendment to the microhematuria guideline
was an important moment for the AUA, and highly
consequential for urologists, healthcare payers
and providers of advanced non-invasive urine-
based diagnostics worldwide. It was particularly
consequential for Pacific Edge, with Cxbladder Triage
receiving a ‘Grade A’
1
recommendation in the guideline
and specific language on its use.
The amendments stand in sharp contrast to
the 2020 guideline, which guided against the use
of urine-based biomarkers in lieu of a cystoscopy.
In making the change, the AUA has demonstrated
its determination to support innovation in
urological practice and improvements
to the existing standard of care by
integrating genomic biomarkers
as an alternative for physicians
to consider as part of their
evaluation of hematuria patients.
It is a significant move that
aligns the AUA guideline
with established practices for
prostate, breast, colon and other
cancers. It also offers significant
benefits to patients, reducing
the burden of unnecessary
cystoscopies in lower risk patients
and improving access to care for a
greater number of patients.
Of importance to investors is that the
language used in the guideline is among the strongest
that could have been envisaged given the available
published evidence, the most significant of which is
our STRATA randomized controlled study
2
. We will
publish more clinical utility evidence for Triage Plus
(the focus of the CREDIBLE study) (see page 9) as
we look to further expand the indications for our tests
in line with our long-term goal to establish Cxbladder
as the preferred urine-biomarker for genomic risk
stratification of hematuria patients.
Meanwhile, the AUA’s recognition of Cxbladder
Triage as the only biomarker with ‘Grade A’ evidence
sends a very strong message to the market.
We have long maintained that the quality of our clinical
evidence establishes the greatest possible barrier for
our competitors. This recommendation reinforces
our first-mover advantage. Meanwhile we are further
differentiated from other urine-based biomarkers
in hematuria evaluation by the intended use to risk
stratify microhematuria populations. Other tests have
only established utility as adjunctive tests to resolve
atypical cytologies and equivocal cystoscopies. These
clear points of difference profoundly mark the ‘moat’
around our business and that we have no current peers.
This achievement, driven by our Clinical Science team,
underscores their pivotal role in creating long-term
value for our shareholders.
From a business perspective, the guideline is
a substantial strategic milestone on which
to build our commercial operations.
We expect the guideline to catalyze
increased testing volume and revenue
despite coverage uncertainty.
Similarly, we expect this to drive
medical policy and commercial
contracting conversations with
the vast number of healthcare
plans in the US such as those
with Blue Cross Blue Shield we
highlighted in the Q3 25 update in
January. It also future proofs Triage
against an ever-increasing evidence
threshold for reimbursement, and it
stands to entrench reliable reimbursement
of Cxbladder, so that we can focus on scaling
our commercial activities profitably without the
distraction of reimbursement risk.
The biggest short-term opportunity is to leverage
the guideline language in our ongoing policy dialogue
and legal action with Novitas and our engagement
with the Centers for Medicare and Medicaid Services
(CMS) over the adverse ‘Genetic Testing in Oncology:
Specific Tests’ (L39365) local coverage determination
(LCD) (see page 3). This LCD, released in January, and
the uncertainty created by its predecessor ‘Genetic
Testing for Oncology’ (DL39365), have continued
to limit the growth of our US business to a rate well
below its potential (see page 3).
LETTER FROM THE CEO
Guideline inclusion validates
and accelerates strategy
“The guideline
clearly marks the
‘moat’ around
our business and
that we have no
genuine peers.”
2
1
The AUA defines ‘Grade A’ evidence as evidence with a high certainty rating and notes evidence of this grade makes it “very confident that the true effect lies close to
that of the estimate of the effect”.
2
Lotan Y, Daneshmand S, Shore N, Black P, Scarpato KP, Patel A, Lough T, Shoskes DA, Raman JD. A Multicenter Prospective Randomized Controlled Trial Comparing
Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The Safe Testing of Risk for Asymptomatic Microhematuria Trial. J Urol 2024

With Cxbladder Triage now in the AUA guideline,
our Clinical Science team is focused on coverage and
guidelines inclusion for Triage Plus and Monitor Plus,
while our R&D Team is focused on simplifying our
portfolio of Cxbladder tests as In Vitro Diagnostic
(IVD)-ready versions. Implicit in this vision for
innovation is that we will need to place greater
emphasis on the ‘D’ in R&D, thus creating the
opportunity for decentralized deployment for our
tests in the rest of the world.
The challenge for Pacific Edge is to make the
most of the immediate commercial opportunities we
have created. In the US this means being recognized
for not only delivering the best clinical outcomes in
the market – a title we can now confidently claim for
Cxbladder Triage with the AUA’s endorsement – but
also for offering the simplest user experience.
We will achieve this second goal by investing in
digital connections that streamline test ordering and
results delivery for an excellent customer experience.
These investments include new integrations with
electronic medical record and pathology laboratory
systems - building on the successful implementations
with organizations like Kaiser Permanente and
Lumea – and enhancements to our customer
portal for clients unable to connect directly to our
systems. Additionally, we need to further develop
and appropriately incentivize our sales, customer
service, and medical affairs teams, empowering them
to effectively communicate and deliver Cxbladder’s
clinical and economic value wherever demand is
identified.
We remain steadfast on our vision, while adaptable
regarding how we deliver, and I am looking forward to
reporting on progress in the new financial year.
With my warm regards,
Dr Peter Meintjes
Chief Executive
LETTER FROM THE CEO CONTINUED
Cxbladder tests processed at Pacific Edge’s laboratories in laboratories in Q4 25 improved 6.8% on the
prior quarter (Q3 25), lifted by increased adoption in the US.
Cxbladder tests processed at Pacific Edge’s laboratories in laboratories in Q4 25 improved 6.8% on the
prior quarter (Q3 25), lifted by increased adoption in the US.
Total laboratory throughput (TLT) in Q4 25 rose to 7,577 tests from 7,092 tests in Q3 25.
Q4 25 US TLT was 6,490 tests up 11.7% from the 5,808 tests in Q3 25, lifted by an increase in the
number of unique US ordering clinicians to 914 from 866
1
in Q3 25 and an increase in the number of
tests each US clinician orders to 7.1 from 6.7
1
in Q3 25. The US volume lift follows continuing incremental
improvements in sales force efficiency, up to 406 tests per sales FTE from 379 tests in Q3 25, and a
seasonal post-holiday rebound.
The American Urological Association’s (AUA) February 2025 inclusion of Cxbladder Triage with a
‘Grade A’
2
evidence rating in its new microhematuria guideline has changed our sales pitch to clinicians,
medical policy makers and healthcare payers, and generated renewed interest in Cxbladder among the
broader urology customer base.
The longer-term impact of this change may take some time to affect the daily lab throughput figures,
and as we await various coverage-related events, our commercial team will focus on profitability per sales
resource in the wake of the guideline update before seeking to expand the size of the team.
Q4 25 Asia Pacific TLT was 1,087 tests down 15% on the 1,284 tests in Q3 25, with the decrease partly
reflecting a reduction in evaluation and clinical study volumes as we continue to focus on commercial
testing volumes and see the impact of budgetary constraints within some Health New Zealand – Te Whatu
Ora regions.
Total volumes for the year to the end of March 2025 (FY 25) were down 11.5% to 28,894 tests from
32,633 in FY 24, with the fall reflecting the reduction in the sales force compared to the prior financial year
in response to the uncertainty over Medicare coverage of Cxbladder.
TEST VOLUMES
Cxbladder volumes rise with increased US clinical usage
3
1
The number of ordering clinicians in Q3 25 and the tests per ordering clinician has been restated to reflect post period adjustments.
2
The AUA defines ‘Grade A’ evidence as evidence with a high certainty rating and notes evidence of this grade makes it “very confident that the true
effect lies close to that of the estimate of the effect”.

-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
Q4 22
5,290
952
6,242
Q1 23
6,073
983
7,056
Q2 25
5,682
1,360
7,042
Q3 25
5,808
1,284
7,092
Q4 25
6,490
1,087
7,577
Q2 23
6,699
1,165
7,864
Q3 23
6,629
1,139
7,768
Q4 23
1,061
8,877
Q1 24
8,627
1,079
9,706
Q2 24
7,335
1,199
8,534
Q3 24
6,041
1,142
7,183
Q1 25
5,905
1,278
7,183
Q4 24
6,099
1,111
7,210
APAC
-
200
400
600
800
1,000
1,200
1,400
1,600
-
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
US Ordering Clinicians
Tests/Clinician
US ORDERING CLINICIANS (LHS)
Q4 22
789
Q1 23
895
890866
Q1 25
867
Q2 25Q3 25Q2 23
978
Q3 23
1,082
Q4 23
1,150
Q1 24
1,232
Q2 24
1,147
Q3 24
1,016
Q4 24
915914
TESTS/ORDERING CLINICIANS (RHS)
7.0
6.1
6.7
6.8
6.8
6.4
6.8
-
10
20
30
40
50
60
-
50
100
150
300
200
250
70350
80400
Average Sales FTE
Average US Test Volume/Sales FTE
US AVERAGE SALES FTE (LHS)US TEST VOLUMES/SALES FTE (RHS)
187
222
226
201
239
288
265
28
Q4 22
27
Q1 23

30
Q2 23
33
Q3 23
33
Q4 23
30
Q1 24
28
Q2 24
21
Q3 24
16
Q4 24
15
Q1 25
15
Q2 25
1516
Q3 25
Q4 25
Q4 25
292
5.9
6.7
381
6.8
403
379
7.1
406
6.4
6.7
379
7,816
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
Q4 22
5,290
952
6,242
Q1 23
6,073
983
7,056
Q2 25
5,682
1,360
7,042
Q3 25
5,808
1,284
7,092
Q4 25
6,490
1,087
7,577
Q2 23
6,699
1,165
7,864
Q3 23
6,629
1,139
7,768
Q4 23
1,061
8,877
Q1 24
8,627
1,079
9,706
Q2 24
7,335
1,199
8,534
Q3 24
6,041
1,142
7,183
Q1 25
5,905
1,278
7,183
Q4 24
6,099
1,111
7,210
APAC
-
200
400
600
800
1,000
1,200
1,400
1,600
-
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
US Ordering Clinicians
Tests/Clinician
US ORDERING CLINICIANS (LHS)
Q4 22
789
Q1 23
895
890866
Q1 25
867
Q2 25Q3 25Q2 23
978
Q3 23
1,082
Q4 23
1,150
Q1 24
1,232
Q2 24
1,147
Q3 24
1,016
Q4 24
915914
TESTS/ORDERING CLINICIANS (RHS)
7.0
6.1
6.7
6.8
6.8
6.4
6.8
-
10
20
30
40
50
60
-
50
100
150
300
200
250
70350
80400
Average Sales FTE
Average US Test Volume/Sales FTE
US AVERAGE SALES FTE (LHS)US TEST VOLUMES/SALES FTE (RHS)
187
222
226
201
239
288
265
28
Q4 22
27
Q1 23

30
Q2 23
33
Q3 23
33
Q4 23
30
Q1 24
28
Q2 24
21
Q3 24
16
Q4 24
15
Q1 25
15
Q2 25
1516
Q3 25
Q4 25
Q4 25
292
5.9
6.7
381
6.8
403
379
7.1
406
6.4
6.7
379
7,816
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
Q4 22
5,290
952
6,242
Q1 23
6,073
983
7,056
Q2 25
5,682
1,360
7,042
Q3 25
5,808
1,284
7,092
Q4 25
6,490
1,087
7,577
Q2 23
6,699
1,165
7,864
Q3 23
6,629
1,139
7,768
Q4 23
1,061
8,877
Q1 24
8,627
1,079
9,706
Q2 24
7,335
1,199
8,534
Q3 24
6,041
1,142
7,183
Q1 25
5,905
1,278
7,183
Q4 24
6,099
1,111
7,210
APAC
-
200
400
600
800
1,000
1,200
1,400
1,600
-
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
US Ordering Clinicians
Tests/Clinician
US ORDERING CLINICIANS (LHS)
Q4 22
789
Q1 23
895
890866
Q1 25
867
Q2 25Q3 25Q2 23
978
Q3 23
1,082
Q4 23
1,150
Q1 24
1,232
Q2 24
1,147
Q3 24
1,016
Q4 24
915914
TESTS/ORDERING CLINICIANS (RHS)
7.0
6.1
6.7
6.8
6.8
6.4
6.8
-
10
20
30
40
50
60
-
50
100
150
300
200
250
70350
80400
Average Sales FTE
Average US Test Volume/Sales FTE
US AVERAGE SALES FTE (LHS)US TEST VOLUMES/SALES FTE (RHS)
187
222
226
201
239
288
265
28
Q4 22
27
Q1 23

30
Q2 23
33
Q3 23
33
Q4 23
30
Q1 24
28
Q2 24
21
Q3 24
16
Q4 24
15
Q1 25
15
Q2 25
1516
Q3 25
Q4 25
Q4 25
292
5.9
6.7
381
6.8
403
379
7.1
406
6.4
6.7
379
7,816
FIGURE 1: TOTAL TEST VOLUMES
1
FIGURE 2: CXBLADDER CLINICAL ADOPTION
FIGURE 3: US SALES FORCE EFFICIENCY
TEST VOLUMES CONTINUED
1
Volumes in some prior quarters of FY24 are marginally different from those reported in earlier investor updates reflecting post period adjustments.
The number of ordering clinicians in Q3 25 and Q1 25 and the tests per ordering clinician in Q3 25 have been restated to reflect post period adjustments.
4

5
REVENUE GENERATION
1
Pacific Edge estimates
2
Lotan Y, Daneshmand S, Shore N, Black P, Scarpato KP, Patel A, Lough T, Shoskes DA, Raman JD. A Multicenter Prospective Randomized Controlled Trial Comparing
Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The Safe Testing of Risk for Asymptomatic Microhematuria Trial. J Urol 2024.
3
Harvey JC, Cambridge LM, Ellen CW, Colonval M, Hazlett JA, Newell J, Zhou X, Guilford PJ. Analytical Validation of Cxbladder® Detect, Triage, and Monitor:
Assays for Detection and Management of Urothelial Carcinoma. Diagnostics. 2024; 14(18):2061.

Copyright © 2025 American Urological Association Education and Research, Inc. ®
1
Any person or company accessing this guideline with the intent of using the guideline for promotional purposes must obtain a licensable copy.

MMIICCRROOHHE EMMAATTUURRIIAA::
AAUUAA//SSUUFFUU GGUUIIDDEELLIINNEE ((22002200,, AAMMEENNDDEEDD 22002255))
Guideline Panel
Daniel A. Barocas, MD, MPH;* Stephen Boorjian, MD;* Ronald Alvarez, MD, MBA;
Tracy M. Downs, MD; Cary P. Gross, MD; Blake Hamilton, MD; Kathleen Kobashi, MD;
Robert Lipman; Yair Lotan, MD; Casey Ng, MD; Matthew Nielsen, MD, MS; Andrew
Peterson, MD; Jay Raman, MD; Rebecca Smith-Bindman, MD
* Equal author contribution
Amendment Panel
Daniel A. Barocas, MD, MPH, FACS; Yair Lotan, MD; Richard S. Matulewicz, MD, MSCI,
MS; Jay D. Raman, MD, FACS, FRCS(Glasg); Mary E. Westerman, MD
Amendment Staff and Consultants
Lauren J. Pak, MHS, MS; Erin Kirkby, MS; Lesley Souter, PhD
SUMMARY
Purpose
The purpose of this guideline is to provide a clinical framework for the diagnosis, evaluation, and follow-up of microhematuria
(MH).
Methodology
OVID was used to systematically search MEDLINE and EMBASE databases for articles evaluating hematuria using criteria
determined by the expert panel. The initial draft evidence report included evidence published from January 2010 through
February 2019. A second search conducted to update the report included studies published up to December 2019. Five
systematic reviews and 91 primary literature studies met the study selection criteria and were chosen to form the evidence
base. These publications were used to create the majority of the clinical framework. When sufficient evidence existed, the
body of evidence for a particular modality was assigned a strength rating of A (high), B (moderate), or C (low); and evidence-
based statements of Strong, Moderate, or Conditional Recommendation were developed. Additional information is provided
as Clinical Principles and Expert Opinions when insufficient evidence exists. In 2024, this Guideline was reviewed via the
AUA update literature review (ULR) process, which identified 82 studies for full-text review that were published between
December 2019 and June 7, 2024. Of those 82 studies, 23 met inclusion criteria for qualitative synthesis. The subsequent
amendment is based on data released since the initial 2020 publication of this Guideline.


American Urological Association (AUA)/
Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU)
APPROVED BY THE AUA
BOARD OF DIRECTORS
FEBRUARY 2025
Authors’ disclosure of potential
conflicts of interest and
author/staff contributions appear
at the end of the article.

© 2025 by the American
Urological Association

Guideline supportive of commercial operations
The American Urological Association’s inclusion of Cxbladder Triage as a recommended alternative to the
standard of care in the evaluation of microhematuria (MH) patients, represents a substantial strategic milestone
on which to build our commercial operations.
The guideline, released in late February, will help to reduce the burden of unnecessary cystoscopies for lower risk
patients, resulting in less patient discomfort, lower morbidity, and improved access to care by reducing wait times.
It states urologists may use urine-based biomarkers for intermediate-risk patients presenting with MH to assist
their decision on whether to defer a cystoscopy: “In appropriately counseled intermediate-risk patients who want
to avoid cystoscopy and accept the risk of forgoing direct visual inspection of the bladder urothelium, clinicians
may offer urine cytology or validated urine-based tumor markers... to facilitate the decision regarding the utility of
cystoscopy. Renal and bladder ultrasound should still be performed in these cases.”
Intermediate risk’ patients represent a large serviceable market for Triage, amounting to anywhere from 40-
70% of all MH patients, or up to 3.5 million patients per year in the US alone
1
. This figure represents the base-line
population indicated by the guideline, but we expect through the development of further evidence and clinician
education to extend our addressable market to almost all patients presenting with hematuria.
In a significant achievement, the guideline mentions Cxbladder Triage as the only urine-based biomarker test that
has ‘Grade A’ evidence from a randomized controlled trial (the STRATA study
2
) in support of this recommendation.
The study was the first randomized controlled trial of any urine biomarker and demonstrated that Cxbladder Triage
could safely and effectively reduce cystoscopies by as much as 59% without missing tumors.
The specific mention of Cxbladder Triage in the guideline reinforces our first mover advantage and establishes
a high evidentiary standard that any other test must meet to be competitive.
The largest immediate opportunity is to leverage the guideline language in our ongoing policy dialogue with
Medicare Administrative Contractor Novitas and the Centers for Medicare and Medicaid Services over the adverse
‘Genetic Testing in Oncology: Specific Tests’ (L39365) local coverage determination (LCD) released in January.
Should these discussions not yield the certainty we seek, and the LCD comes into effect on 24 April 2025, we
will use the new guideline, and the evidence ignored by Novitas as it finalized the LCD (including the STRATA
study and updated Analytical Validation studies of Triage and Detect
3
). In the meantime, we have submitted a
reconsideration request for Cxbladder Triage under the ‘Biomarkers for Oncology’ LCD (L35396) using all current
evidence and Novitas has deemed our submission valid.
Separately, the new guideline provides additional support to our contracting negotiations with healthcare
plans across the US and in new markets and will help to catalyze change in the practice of independent
urologists worldwide.

6
GUIDELINES
Guideline success featured at key meeting
EVIDENCE INTEGRITY
Novitas’ flawed understanding of Cxbladder evidence
A Pacific Edge symposium – Cxbladder Triage: Risk Stratification for Patients with Microhematuria – attracted
significant interest at the Annual Meeting of the Southeastern Section of the American Urological Association
(SESAUA) in mid-March.
SESAUA was the first opportunity for Pacific Edge to promote Cxbladder Triage since its inclusion in the
guideline. The symposium was a standing room only event and was led by Dr Zachary Klaassen, Urologic
Oncologist and Associate Professor of Urology; Wellstar MCG Health and the Georgia Cancer Center. It
covered the details of the guideline, and the benefits Cxbladder Triage offered in reducing the burden of
unnecessary cystoscopies for those with a lower risk of cancer, resulting in less patient discomfort and
morbidity.
Watch the symposium online here
Pacific Edge on 20 February released a point-by-point
rebuttal of the evidentiary review used to support
the finalization of the adverse ‘Genetic Testing in
Oncology: Specific Tests’ (L39365) LCD that threatens
to end Medicare coverage of our tests.
Our goal in releasing this rebuttal was to ensure all
our stakeholders – patients, clinicians, medical policy
makers, healthcare payers, our investors and our own
people – understand our confidence in the clinical
value of Cxbladder.
Pacific Edge’s clinical evidence program is
focused on developing high-quality clinical evidence
for Cxbladder tests in a structured framework of
Analytical Validity, Clinical Validity, and Clinical Utility,
with the endpoints and sample sizes required for
coverage decisions and guideline inclusion. Cxbladder
Triage’s February inclusion in the AUA microhematuria
guideline with a ‘Grade A’ classification of the evidence
supporting the use of it is an unequivocal validation
of this approach and contrasts starkly with Novitas’
review of our evidence portfolio.
Our analysis of the LCD evidentiary review found:
- Novitas conflates feasibility testing of biomarkers
in urine with test development of a specific clinical
diagnostic lab test.
- Novitas misinterprets evidence for Cxbladder Triage
and Detect by framing them as screening tests for
an asymptomatic population, rather than tests to
support clinical decision making.
- Novitas misinterprets evidence for Cxbladder
Detect and Triage because it misunderstands the
patient population targeted by the tests (patients
presenting with hematuria, not asymptomatic
patients).
- Novitas misinterprets evidence for Cxbladder
because it does not understand how the information
generated by the tests is used to guide clinical
decision making.
- Novitas has based its evidentiary review on a
preliminary version of the Cxbladder test, referred to
as uRNA-D, which is not the test offered to Medicare
patients.
Our full rebuttal can be downloaded here

CXBLADDER MONITOR SAVINGS
New evidence supports the clinical and economic
value of Cxbladder Monitor
Two new studies examining the deployment of Cxbladder Monitor in
Australia and New Zealand have demonstrated the clinical utility of the
test for the surveillance for the recurrence of bladder cancer and the cost
savings it delivers to healthcare payers. This real-world evidence is further
supported by a new health economics study that demonstrates the savings
the test offers to healthcare payers against the American Urological
Association standard of care.
Monitor garners support in Australia
A new real world evidence study conducted by Northern Health in Melbourne, Australia, has
demonstrated the effectiveness and safety of Cxbladder Monitor as an alternative approach in the
surveillance for bladder cancer recurrence
1
.
The retrospective study was designed to determine whether clinically significant bladder
cancer recurrences, specifically progression to invasive or metastatic disease, were missed using
Northern Health’s protocol, which alternated annually between a Cxbladder Monitor test and flexible
cystoscopy, compared to the standard yearly cystoscopy recommended by the European Association
of Urology (EAU).
The findings highlighted notable clinical and operational benefits including
the significant potential of Monitor to optimize bladder cancer surveillance
programs, reduce healthcare costs, and substantially improve patient
satisfaction and overall healthcare system efficiency.
Notably, the new protocol achieved a 59% reduction in the hospital’s
surveillance cystoscopy waitlist, greatly improving patient access and
resource allocation.
Financial analysis revealed substantial cost savings, with each Monitor
test being approximately A$850 cheaper compared to conventional
cystoscopy, leading to savings for Northern Health.
The budget impact benefits of Monitor were also affirmed in a Pacific
Edge study accepted for publication in the JU Open Plus journal (see page 8).
The researchers concluded, “An alternating Cxbladder Monitor and Flexible
Cystoscopy surveillance protocol can be safely used for NMIBC
2
patients eligible
for annual surveillance, without clinically significant recurrences being missed. This can also alleviate
a health center’s surveillance cystoscopy waitlist and allow improved patient access to cystoscopy.
Cxbladder Monitor was found to be cheaper, and the patients enthusiastically accepted it as an
alternative to cystoscopy.”
7
1
Guduguntla A, Whish-Wilson T, Chandler L, Gyomber D. A novel bladder cancer surveillance schedule
using bladder Cx for patients on annual surveillance. BJUI Compass. 2025;6(1).
2
Non-muscle invasive bladder cancer
“...the new
protocol achieved
a 59% reduction
in the hospital’s
surveillance
cystoscopy”

CXBLADDER MONITOR SAVINGS CONTINUED
Cxbadder Monitor delivers savings in New Zealand
A retrospective study at Te Whatu Ora Health
in Auckland found Cxbladder Monitor, for the
surveillance for the recurrence of low-risk
non-muscle invasive bladder cancer, is more
patient-friendly, safe and saved the health provider
$39,000
1
over a three-year period.
A study led by Dr Alexandra Gower and
colleagues evaluated 206 urine-based Cxbladder
Monitor tests conducted between 2020 and 2023.
Researchers found Cxbladder Monitor detected
19 positive results, with follow-up cystoscopies
confirming recurrence in four cases. Among negative
results, 7% later showed recurrence in follow up
examinations including a single high-grade case (0.5%). Patients reported preferring Cxbladder Monitor,
highlighting the benefits of less anxiety, reduced discomfort, and fewer logistical issues associated with
the test when compared to a cystoscopy.
Meanwhile the analysis found substantial cost savings, with Cxbladder Monitor costing $395 per test
versus $643 for a traditional cystoscopy. Over three years, using Cxbladder Monitor, alternated annually
with cystoscopy reduced total expenses at the health provider by nearly $39,000, averaging about
$13,000 saved per year.
The researchers concluded: “Our findings indicate Cxbladder Monitor provides a safe, efficient, and
patient-preferred alternative to routine cystoscopy surveillance. These results could prompt broader
adoption, significantly impacting how bladder cancer surveillance is managed, balancing cost control
and patient well-being.”
A new health economics study has shown that the inclusion of Cxbladder Monitor into bladder
cancer recurrence surveillance protocols can save healthcare payers as much as $686
2
per
patient over a five year surveillance period.
The study
3
, accepted for publication in the JU Open Plus journal, compared the American
Urological Association (AUA) bladder cancer surveillance protocols, with a new protocol that
included Monitor in the surveillance program nine months after diagnosis. Under the Cxbladder
protocol, cystoscopies were deferred if the Monitor test returned negative results, postponing
invasive examinations until the next routine check-up.
Compared to the AUA standard of care, Cxbladder Monitor reduced mean total costs by
$68,621 for 100 patients over 5 years or $137 per patient per year. Additionally, this approach
reduced the number of cystoscopies by 129 examinations per 100 patients (0.31 per patient per
year), with no difference in delayed cancer diagnosis, highlighting both the economic and clinical
efficiencies of the Cxbladder Monitor test.
... and against the AUA standard of care
8
2
All references to dollar amounts in this item are US dollars.
3
Mark Tyson MD, MPH, John P. Sfakianos MD, Daniel A Shoskes MD, Tobias Muench, Kim Seemann, Rhodri Saunders, Siamak Daneshmand.
Economic Impact Model of Incorporating Cxbladder Monitor in the Surveillance of Non-Muscle Invasive Bladder Cancer; article accepted for
publication.
1
All references to dollar amounts in this item are NZ dollars.

CLINICAL EVIDENCE PROGRAM
Evidence to drive clinical practice change
Our clinical study program is at the foundation of Pacific Edge’s value. We are focused on generating the compelling
clinical evidence required to drive behavior change in physicians. Specifically, we seek to produce evidence that
is founded on the frameworks of Analytical Validity (AV), Clinical Validity (CV) and Clinical Utility (CU), with the
endpoints and sample sizes required for coverage decisions and guideline inclusion.
STUDYGOALPOPULATION AND
USE
STATUS
STRATA
Safe Testing
of Risk for
AsymptomaTic
MicrohematuriA
• CU for Triage
• CV/CU for
Triage Plus
(retrospective)
• Microhematuria
(MH)
• Risk stratification
- Recruitment closed with 555 patients including
223 low risk patients (test and control) with
interim analysis results published in Journal of
Urology and led to Guidelines inclusion for 2025
update.
- Monitoring for final analysis completed mid-Aug,
some re-work needed. Database lock expected
Q2 2025 and final Clinical Study Report (CSR)
expected Q3-4 2025.
DRIVE
Detection and
Risk stratification
In VEterans
presenting with
hematuria
• CV for Triage Plus
for a Veterans’
cohort
• Data for MH
pooled analysis
• MH and gross
hematuria (GH)
• Risk stratification
- Enrolment closed with 710 patients enrolled
including 46 tumour confirmed patients
(target was 45) from across 10 US Veteran Affairs
(VA) sites.
- Database lock completed and publication
submission expected by March 2025.
microDRIVE
Detection and
Risk stratification
In VEterans
presenting with
microhematuria
• CV of Triage Plus
• Data for MH
pooled analysis
• MH
• Detection
- Currently a decentralised study across all
VAMC
1
coordinated using a single US VA.
- Protocol amendment approved - 3 more sites to
join in Q2 2025 to increase enrolment.
- 467 patients have consented for the study
with 305 samples received to date.
- The target is 1000 patients with 35 tumour
confirmed patients.
- Last patient in is now projected to be
Q3 2025.
AUSSIE
Australian Urologic
risk Stratification
of patientS wIth
hEmaturia
• CV of Triage
Plus (Australian
cohort)
• Data for MH
pooled analysis
• MH and GH
• Risk stratification
- The target is 35 Urothelial Cancer (UC) confirmed
patients including a minimum of 10 MH patients.
- Currently 543 subjects enrolled with 35 UC
confirmed including 5 MH patients.
- Last patient in projected to be Q3 2025.
POOLED
ANALYSIS
• CV of Triage Plus • MH and GH
• Risk stratification
- MH (and separately GH patient data where
available) from DRIVE, AUSSIE and microDRIVE
will be pooled and performance determined.
- Paper submission is one quarter after publication
of DRIVE, microDRIVE and AUSSIE.
LOBSTER
LOngitudinal
Bladder cancer
Study for
Tumor Recurrence
• CV of Monitor and
Monitor
+
• Surveillance
• Risk stratification
- Enrolment will be complete when 75 UC
recurrences are observed across 10–15 sites.
- Enrolment is 388 subjects providing 894 samples
with 52 UC recurrences observed to date.
- We project last patient in (to observe 75
recurrences) between Q4 2025 to Q2 2026.
CREDIBLE
Cystoscopic
REDuction
In BLadder
Evaluations for
microhematuria
• CU of Triage Plus

• MH
• Risk stratification
- Study level Institutional Review Board (IRB)
approvals received, site level IRB approvals for
7 sites, contracts finalized for 10 of expected 15
sites.
- Currently amending the protocol to address KOL
feedback and adjust to AUA guideline changes.
- Enrolment due to commence 1 April 2025.
Quarterly dates are calendar year not financial years
9
1
Veterans Affairs Medical Centers

ABOUT US
Pacific Edge Limited (NZX/ASX: PEB) is a global cancer diagnostics company leading the way in the development
and commercialization of bladder cancer diagnostic and prognostic tests for patients presenting with hematuria
or surveillance of recurrent disease. Headquartered in Dunedin, New Zealand, the company provides its suite of
Cxbladder tests globally through its wholly owned, and CLIA certified, laboratories in New Zealand and the USA.
VISIT US ONLINE:
www.pacificedgedx.com
www.cxbladder.com
FOLLOW US ON SOCIAL MEDIA:
www.facebook.com/PacificEdgeLtd
www.facebook.com/Cxbladder
www.twitter.com/PacificEdgeLtd
www.twitter.com/Cxbladder
www.linkedin.com/company/pacific-edge-ltd
CONTACT US:
Centre for Innovation
87 St David Street
PO Box 56
Dunedin 9016, New Zealand
T: 0800 555 563 (NZ)
+64 3 577 6733 (Overseas)
E: investors@pacificedge.co.nz