Pacific Edge Releases Quarterly Volumes for Q3 FY25

22 January 2025


PACIFIC EDGE RELEASES QUARTERLY VOLUMES FOR Q3 FY25
Cxbladder test volumes steady amid seasonal slow down

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today
announces tests processed at its laboratories in the three months to the end of December 2024
(Q3 25) were steady on the prior quarter (Q2 25).
Novitas’ deliberations remained the overriding challenge to test volume growth, although the
seasonal holiday slowdown also impacted volumes in the quarter. Against this, the addition of
one FTE to the US sales team for the last month of the period, steady demand from our US
customer Kaiser Permanente, the sustained benefits of our sales force efficiency gains, and
an uplift in demand from the US clinicians most supportive of our tests diluted the impact of
these factors.
Total laboratory throughput (TLT) in Q3 25 rose 0.7% to 7,092 tests from 7,042 tests in Q2 25
1
.
US TLT was 5,808 tests up 2.2% on the 5,682 in Q2 25. Our sales force efficiency metric was
379 tests per sales FTE, flat on the prior quarter.
Tests per unique US ordering clinician (our preferred metric for measuring customer
commitment to Cxbladder) was up 9.1% in Q3 25 to 7.0 compared to 6.4 in Q2 25, while unique
ordering clinicians in the quarter fell to 834 down from 890 in Q2 25.
These trends reflect the ongoing impact of Medicare uncertainty and the sales force efforts to
maximise demand from Cxbladder’s strongest supporters. Asia Pacific volumes were down
5.6% to 1,284 tests from 1,360
1
in Q2 25, a move that largely reflected the seasonal holiday
slowdown in New Zealand.
The Q3 25 investor update also provides a detailed analysis of the finalized ‘Genetic Testing
in Oncology: Specific Tests’ (L39365) Local Coverage Determination released on Thursday 9
January, and Pacific Edge’s response to it including:
1. Our determination to pursue a preliminary injunction if our efforts to negotiate a
withdrawal or revision to the finalized LCD prove unsuccessful
2. The path the company has set to regaining reimbursement certainty and our confidence
of achieving that goal
We also highlight the recent successes we have had contracting with the BlueCross Blue
Shield network of health insurers to make our tests ‘in-network, creating a new non-Medicare
revenue stream in the US.
Released for an on behalf of Pacific Edge by Grant Gibson, Chief Financial Officer.

1
APAC test volumes for Q2 25 have been revised to 1,360 from the 1,363 reported in the October 2024
Investor Update.

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.

---

INSIDE
Letter from the CEO 2
Q3 25 test volumes 3
Novitas’ LCD 5
Clinical study program update 7
Blue Cross Blue Shield GPO
Agreement 9
Triage Plus pricing 9
JANUARY 2025
INVESTOR UPDATE

Dear Shareholders,
Pacific Edge enters the New Year facing the loss
of Medicare coverage of our Cxbladder tests, an
outcome we had strenuously fought for more than
two years to avoid.
Prior to Novitas
1
finalizing the draft ‘Genetic Testing
for Oncology’ (DL 39365) on 9 January as a non-
coverage determination under the new name ‘Genetic
Testing in Oncology: Specific Tests’ (L39365), we
believed we had mounted a compelling argument to
retain our existing coverage arrangements.
However, in making its decision – one that has
impacted other companies as well as Pacific Edge –
Novitas has relied on its flawed understanding of how
our tests are used in clinical practice (the risk
stratification of patients presenting
with hematuria). It has relied on
a flawed review of the high
quality peer reviewed evidence
supporting the use of our tests.
It also ignored the compelling
new evidence that has emerged
since it published the revised
draft determination in July
2023 (our STRATA
2
study and
new Analytical Validation data
3
)
despite having been notified of
the evidence and also stating in
writing that it would incorporate
that evidence in the review (see
page 5).
Novitas’ evidentiary review is particularly
disappointing because it questions Pacific Edge’s
steadfast commitment to producing only the highest
standard of clinical evidence. We are determined
that this should not go unchallenged. As a matter of
best practice, we have requested a review of Novitas’
L39365 from an independent consulting medical
director to provide an objective 3rd party analysis to
consider that we will publish on our website and use
as needed for internal and external purposes.
The new issues now evident through the
finalization of the LCD, combined with the significant
harm this determination could do to Pacific Edge,
provide standing for a legal challenge and we have
resolved to escalate should our attempts to negotiate
a better solution fail.
Our goal is to retire the LCD and/or remove the
non-coverage language of Cxbladder tests. We will
seek to engage with Novitas’ Medical Affairs, its
parent company GuideWell and other stakeholders
including the Centers for Medicare & Medicaid
Services (CMS) and the US Department of Health and
Human Services Office of the General Counsel (OGC).
As the test volumes we release today show
(see page 4) the uncertainty over the draft LCD
has significantly hampered our growth, principally
because it has forced us to reduce investment in
our commercial team to preserve capital in case of
a decision such as the one we have now received.
With Medicare accounting for circa 54% of our US
commercial tests, this LCD has profound
implications for the future of the business.
The LCD is a setback, but we
continue to bill and expect to receive
continued reimbursement from
contracted US payers without
interruption, notably Kaiser
Permanente and the US Veterans
Administration. Moreover we
are receiving reimbursement
from an increasing number of
Blue Cross Blue Shield plans (see
page 9), as well as non-contracted
private payers in line with historic
reimbursement rates. Meanwhile,
we see many potential short and
medium term developments, in addition
to a successful legal challenge, that could
catalyze progress towards our goal of establishing
Cxbladder in clinical practice for bladder cancer
diagnosis.
Principal among these is the American
Urological Association’s (AUA) ongoing review of
its microhematuria guideline. This review, prompted
by our STRATA study, has the potential to establish
guideline inclusion supporting the use of Cxbladder
in the evaluation of patients presenting with
microhematuria. Guideline revisions are typically
published as a peer-reviewed article in the AUA’s
Journal of Urology, which is released monthly, but
would be available online immediately when accepted
for publication. We would expect to leverage such
inclusion in our ongoing conversations with CMS
LETTER FROM THE CEO
2025: Mounting a multifaceted
challenge to a flawed LCD
Our goal is to
retire the LCD
and/or remove
the non-coverage
language of
Cxbladder tests
2
1
Novitas is the Medicare Administrative Contractor (MAC) charged by the centers for Medicare & Medicaid Services for
making Medicare policy decisions in the region where our US laboratory is located.
2
Lotan et al (2024). 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 et al (2024) Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and
Management of Urothelial Carcinoma. Diagnostics. 2024; 14(18):2061.

and Novitas and, if necessary, will be used as part of
a reconsideration request. Our STRATA study and
the new analytical validation data we published in
September will be used in a similar fashion will be
used as part of a reconsideration request.
We remain confident that over the longer term that
reliable reimbursement is a consequence of our clinical
evidence generation program (see page 7) and the
clinical evidence being generated externally. Notably,
we are on track to submit the results of our DRIVE
study for publication ahead of the AUA meeting in
April, while Kaiser Permanente is also set to present
real world evidence of Cxbladder Triage at the same
meeting as a moderated poster (see page 8).
Importantly, we expect the DRIVE study,
which is targeted at demonstrating the clinical
validity of Cxbladder Triage Plus in a clearly
defined patient population of micro and gross
hematuria patients, to also provide the grounds for
a reconsideration request. With the DRIVE study
focused on demonstrating validity within a US
veterans’ population, it will also bolster our case for
the Veteran’s Administration - one of the largest
healthcare providers in the US after Medicare and
Medicaid - to include Cxbladder in its medical policy.
Longer term our CREDIBLE study – a randomized
control trial aimed at demonstrating the clinical
utility of Cxbladder Triage Plus, will seek to entrench
Cxbladder in clinical practice. The study is gearing up
to enroll its first patient in February 2025 after the
meeting of the principal investigators at the Society
of Urologic Oncology (SUO) Annual Meeting in Dallas,
Texas in December 2024 (see page 8).
We thank you for your ongoing support as we
drive these initiatives forward and work towards
realizing the significant potential we see for Pacific
Edge and Cxbladder.
We wish you a happy and productive start to the
New Year and look forward to updating you on our
progress.
Best regards
Dr Peter Meintjes
Chief Executive
LETTER FROM THE CEO CONTINUED
Tests processed through Pacific Edge’s laboratories in the three months to the end of December 2024
(Q3 25) were steady on the prior quarter (Q2 25) as we awaited clarity on Medicare coverage of our
tests.
Novitas’ deliberations remained the overiding challenge to test volume growth, although the seasonal
holiday slowdown also impacted volumes in the quarter. Against this, the addition of one FTE to the US
sales team for the last month of the period, steady demand from our US customer Kaiser Permanente, the
sustained benefits of our sales force efficiency gains, and an uplift in demand from the US clinicians most
supportive of our tests diluted the impact of these factors.
Total laboratory throughput (TLT) in Q3 25 rose 0.7% to 7,092 tests from 7,042 tests in Q2 25. US TLT
was 5,808 tests up 2.2 % on the 5,682 in Q2 25. Our sales force efficiency metric was 379 tests per sales
FTE, flat on the prior quarter.
Tests per unique US ordering clinician (our preferred metric for measuring customer commitment
to Cxbladder) was up 9.1% in Q3 25 to 7.0 compared to 6.4 in Q2 25, while unique ordering clinicians in
the quarter fell to 834 down from 890 in Q2 25. These trends reflect the ongoing impact of Medicare
uncertainty and the sales force efforts to maximise demand from Cxbladder’s strongest supporters. Asia
Pacific volumes were down 5.6% to 1,284 tests from 1,360
1
in Q2 25, a move that largely reflected the
seasonal holiday slowdown in New Zealand and Australia.
TEST VOLUMES
Test volumes hold steady
3
1
APAC test volumes for Q2 25 have been revised to 1,360 from the 1,363 reported in the October 2024 Investor Update.

-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
Q3 22
4,591
1,117
5,708
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
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)
Q3 22
741
Q4 22
789
Q1 23
895
890834
Q1 25
869
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
915
TESTS/ORDERING CLINICIANS (RHS)
7.0
6.2
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)
160
187
222
226
201
239
288
265
29
Q3 22
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
15
Q3 25
292
5.9
6.7
381
6.8
6.4
403
7.0
379379
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
Q3 22
4,591
1,117
5,708
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
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)
Q3 22
741
Q4 22
789
Q1 23
895
890834
Q1 25
869
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
915
TESTS/ORDERING CLINICIANS (RHS)
7.0
6.2
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)
160
187
222
226
201
239
288
265
29
Q3 22
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
15
Q3 25
292
5.9
6.7
381
6.8
6.4
403
7.0
379379
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
Q3 22
4,591
1,117
5,708
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
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)
Q3 22
741
Q4 22
789
Q1 23
895
890834
Q1 25
869
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
915
TESTS/ORDERING CLINICIANS (RHS)
7.0
6.2
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)
160
187
222
226
201
239
288
265
29
Q3 22
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
15
Q3 25
292
5.9
6.7
381
6.8
6.4
403
7.0
379379
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.
4

5
NOVITAS LCD
A FLAWED MEDICARE DETERMINATION
Novitas has followed a flawed process in finalizing the Genetic Testing
in Oncology: Specific Tests” (L39365)’ Local Coverage Determination. In
making its decision it has also relied on its flawed understanding of how
our tests are used in clinical practice (the risk stratification of patients
presenting with hematuria), and its flawed review of the high-quality
peer review evidence supporting the use of our tests.

A fundamental departure from
the ‘Genetic testing for oncology’ draft
The ‘Genetic Testing in Oncology: Specific Tests’ (L39365)’ LCD fundamentally departs from the
structure of the draft ‘Genetic Testing for Oncology’ (DL 39365) determination.
It now amounts to an evidentiary review and a non-coverage determination of specific tests including
Cxbladder. It no longer preemptively excludes tests that have not yet been commercialized and excludes
the draft’s reliance on third-party databases for Medicare coverage determinations.
Its conclusion that “Cxbladder [Triage, Detect and Monitor] are not reasonable and necessary to
support positive outcomes in the management of bladder cancer” is meanwhile based on flawed
assumptions and a misunderstanding of how our tests are integrated into clinical practice.
Specifically, it conflates hematuria evaluation with cancer screening, focusing on Cxbladder’s low
Positive Predictive Value (PPV) and its potential to deliver false positives rather than the clinical utility of
our tests in risk stratifying patients into those that would benefit from a more invasive medical evaluation
and those that would not.
It repeats its flawed analysis of the existing Cxbladder test evidence that conflates biomarker discovery
with test development resulting in a substantial misunderstanding on the clinical validation of our tests.
It also failed to consider new peer reviewed evidence supporting the use of Cxbladder published since
the revised draft determination in July 2023, despite having been notified of the evidence and stating in
writing that it would incorporate that evidence in the review.
This evidence included: the ground-breaking STRATA randomized control study published early last
year, which demonstrated the Clinical Utility of Cxbladder Triage, and showed that clinicians substantially
reduced the number of cystoscopies they undertook it they were able to use the results of the test in their
evaluation. The analytical validation data of Cxbladder Detect, Triage and Monitor published in September
2024 was also ignored.

NOVITAS LCD CONTINUED
Seeking a fair hearing before pursuing legal action
Our immediate focus is to seek a negotiated revision or withdrawal of the finalized LCD, but we have
resolved to escalate and seek immediate relief on the basis of the irreparable harm it will do to our
business via a preliminary injunction in the US Federal District Court if our concerns are not heard and
acted upon.
We are seeking immediate dialogue with Novitas and its parent company Guidewell over the
significant shortcomings we see with the LCD. We are making similar representations to the Centers
for Medicare & Medicaid Services (CMS) and its Coverage and Analysis Group, which develops national
policies regarding Medicare coverage and oversees contractor performance and integrity of the
Medicare Program.
We are also seeking to engage with the US Department of Health and Human Services (HHS)
Office of the General Counsel (OGC), which serves as the chief legal advisor to the department and
plays a crucial role in ensuring the lawful and effective operation of HHS programs, including those
administered by CMS.
With these organizations we will highlight what we see as fundamental
process errors in finalizing the LCD, in addition to our concerns over
Novitas’ misunderstanding of how Cxbladder is incorporated into
clinical practice, the flaws in the LCD’s evidentiary review, and the
LCD’s failure to consider new evidence.
We are hopeful that all parties involved in the process will seek
an evidence-based outcome that respects established practice in
urology, established definitions of screening by Medicare and the
United States Preventative Services Task Force (USPSTF) and the
logic of our views. However, if they do not, we have resolved to seek
a preliminary injunction to the LCD based on these points and the fact
that the finalized LCD will likely extinguish most demand for Cxbladder
tests, hurting Medicare patients and physicians and in the process
causing irreparable harm to Pacific Edge.
6
If our efforts at a
negotiations fail,
we have resolved to
seek a preliminary
injunction
Pacific Edge is at its heart an evidence-based organization. We rely on evidence in our scientific
discovery and research.
Our research is focused on producing clinical evidence that is founded on the frameworks of
Analytical Validity, Clinical Validity, and Clinical Utility in defined patient populations. We undertake
our studies with sample sizes with the appropriate statistical power and a focus on endpoints that
can change clinical practice, medical policy and patient outcomes. This framework will ultimately
see our tests integrated into clinical guidelines and gain reimbursement.
The LCD makes a fundamental attack on the credibility of our research and the frameworks we
use to guide it. In response we have requested a review of Novitas’ L39365 from an independent
consulting medical director to further expose its flaws. This will be published on our website and
used in various market access activities.
We have already established a clinical evidence generation program to achieve our long term
goals and it remains on track. In the absence of Novitas withdrawing the LCD, this evidence
provides multiple opportunities for Pacific Edge to seek a reconsideration request for Medicare
coverage.
Our first reconsideration request will include all previously unreviewed clinical evidence,
including the STRATA Study and our Analytical Validation study of Triage, Detect and Monitor,
both of which Novitas said it would consider as part of the evidentiary review but failed to do
so. The DRIVE Study, which has been closed out and is targeted for publication in time for the
AUA annual conference, coupled with an independent real world evidence of Triage’s Clinical
Utility from our US customer Kaiser Permanente will follow. These, as the table on the following
page shows, are the immediate short term opportunities that should be sufficient to re-establish
coverage, but the longer term program continues the approach to strengthen policy and
guideline language for greater coverage certainty and improved reimbursement.
Delivering the clinical evidence policy makers require

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, Clinical Validity, and Clinical Utility, 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
- Monitoring for final analysis completed
mid-Aug, some re-work needed. Database
lock March 2025 and final Clinical Study
Report (CSR) expected Sep 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 48 tumor confirmed
patients (target was 45) from across 10 US
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
VAMCs coordinated through a single US
VA Medical Center. Protocol amendment
provides for addition of 4 more sites to
increase enrolment
- 447 patients have consented for the study
with 224 samples received to date
- The target is 1000 patients with 35 tumor
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 UC confirmed patients
including a minimum of 10 MH patients
- Currently 456 subjects enrolled with 29
UC confirmed including 5 MH patients
- Last patient in projected to be Q2-2025
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 413 subjects providing 810
samples with 48 UC recurrences observed
to date and expected completion is Q3-
2026
CREDIBLE
Cystoscopic REDuction
In BLadder Evaluations
for microhematuria
• CU of Triage Plus

• MH
• Risk stratification
- Protocol IRB approved for 14 and contracts
finalized for 6 of expected 15 sites
- Interim analysis will occur at 600 to
determine if incidence is <5% and if so will
continue until 1000 are enrolled
- Enrolment due to commence February 2025
*Quarterly dates are calendar year not financial years
7
-

CLINICAL EVIDENCE PROGRAM
Triage Plus clinical utility study on the launch pad
Pacific Edge is set to commence the CREDIBLE study next month following a meeting of the principal investigators
at the Society of Urologic Oncology (SUO) Annual Meeting in Dallas, Texas in early December.
CREDIBLE aims to demonstrate the clinical utility of Cxbladder Triage Plus in evaluating patients with
microhematuria, focusing on reducing unnecessary cystoscopies while maintaining diagnostic accuracy. Its team of
principal investigators includes 15 urologists, including 5 from leading universities across the US and the remainder
from community urological centers.
The SUO conference, a key event for professionals in urologic oncology, offered an opportunity for the investigators
to review the study’s protocol and timeline and align themselves on study goals and execution strategies.
The study is a randomized control trial, targeting the enrolment of 1,000 participants, with an interim analysis
after 600 participants with final outcomes anticipated by late 2025. It is designed to generate high-quality
evidence of the test’s clinical utility sufficient to influence standard of care guidelines, healthcare payer medical and
reimbursement policies, and specialist clinical practice.
CREDIBLE is a prospectively enrolled randomized clinical trial: one group is assessed using the American
Urological Association (AUA) Standard of Care guidelines, and the other using Cxbladder Triage Plus. The eligible
patient population include those presenting with microhematuria. Key endpoints include comparing cystoscopy
rates and tumor detection outcomes between the two groups.
8

9
CMS confirms Gapfill to price Triage Plus
TRIAGE PLUS COMMERCIALIZATION
The Centers for Medicare and Medicaid Services (CMS) has affirmed it will follow a Gapfill process to price
Cxbladder Triage Plus, the company’s second generation Cxbladder test for hematuria evaluation. The
CMS price for Triage Plus sets the amount Pacific Edge will be reimbursed for all patients with Medicare
and Medicare Advantage insurance.
CMS agreed with the Pricing Panel that Gapfilling Triage Plus was more appropriate given its view that
there were no suitable crosswalk candidates in the current CMS Clinical Lab Fee Schedule. Gapfill requires
all Medicare Administrative Contractors to recommend an initial price each year in April, and to follow a
notice and comment process that is only finalized in late November.
We continue to focus on preparing our US laboratory for running Triage Plus at scale and will work
with Novitas on provisional pricing for Triage Plus to ensure that a Gapfill recommendation is not limiting
our ability to launch the new test with reliable reimbursement. We remain confident Triage Plus will
achieve a price that will deliver a greater margin both in nominal and percentage terms than the current
generation of products, underpinning our drive towards long-term financial sustainability.
COMMERCIAL CONTRACTING
BCBS AGREEMENTS TO SUPPORT NON-MEDICARE REVENUE
Pacific Edge has signed commercial contracting
agreements with Blue Cross Blue Shield of Texas
(BCBSTX), Blue Cross Blue Shield of Illinois (BCBSIL)
and Wellmark (a BCBS entity covering Iowa and South
Dakota), granting the company ‘in-network’ status.
The contracts will increase the certainty of
payment to Pacific Edge at the allowed price for
Cxbladder tests performed on patients covered by
the insurer and provide an alternative revenue stream
in the absence of coverage policy with Medicare and
Medicare Advantage.
Blue Cross Blue Shield of Texas (BCBSTX) is the
largest health benefits provider in Texas, covering
nearly eight million members. BCBSIL is the largest
commercial carrier in the state of Illinois covering
8,380,136 lives. Nationally, BCBS and its affiliates
provide coverage for 115 million members in all 50 US
states as well as Washington DC, and Puerto Rico.
The agreement establishes a contracted price for
Cxbladder tests that BCBSTX, BCBSIL and Wellmark
will pay Pacific Edge (less a small processing fee)
rather than establishing an ‘allowable’ that typically
does not benefit Pacific Edge. These are the first
agreements with state-wide plans following the
Master agreement the company established with the
BCBS Group Purchasing Organization in August 2024,
which defined an agreed process for payment of
Cxbladder tests.
The success of the negotiations with BCBSTX,
BCBSIL and Wellmark reflects the effectiveness
of clinical utility data from our STRATA study, a
prospectively enrolled randomized clinical trial that
demonstrated Cxbladder’s clinical utility in helping
clinicians to safely and more effectively risk-stratify
low-risk hematuria patients when compared to
AUA guidelines. For healthcare payers, the study
highlighted the benefits of using Cxbladder to
improve patient care and optimize resource use.

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