Pacific Edge Release Quarterly Volumes for Q2 FY25

9 October 2024


PACIFIC EDGE RELEASES QUARTERLY VOLUMES FOR Q2 FY25
Cxbladder test volumes slightly down; Kaiser Permanente and APAC volumes up; US sales
force efficiency gains sustained

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 September
2024 (Q2 25) were slightly lower on the prior quarter (Q1 25).
As detailed in the Q2 25 investor update released today, the Centers for Medicare & Medicaid
Services (CMS)’ July 2024 decision to grant an extension to Novitas, our Medicare
Administrative Contractor, on its deliberations over Medicare coverage of our tests and the
uncertainty associated with the extension added to the challenges faced by the sales team.
However, continuing strong demand from our US customer Kaiser Permanente, the sustained
benefits of our sales force efficiency gains and a lift in volume in the APAC region diluted the
impact of these factors.
The investor update also provides detail on the catalysts for positive progress in the coming
months including:
• The American Urological Association’s review of its microhematuria guideline, and the
review’s potential to recognize the clinical and economic value of urine biomarkers
such as Cxbladder and drive changes in clinical practice and the medical and
reimbursement policies of healthcare payers, including Medicare.
• A study by the Southern California Permanente Medical Group, whose preliminary data
demonstrates the clinical utility of Cxbladder Triage, and advances in our clinical
evidence program, could provide for clinical practice and payer reimbursement policy
change.
• Our approach to achieving a CMS price for Detect
+
that recognizes its clinical and
economic value in the evaluation of hematuria and our strategy (and required
antecedents) for the commercial launch of the test in 2025.
Total laboratory throughput (TLT) in Q2 25 fell 2.0% to 7,045 tests, a figure slightly down on
the 7,188 tests in Q1 25. US TLT was 5,682 tests down 3.8% on the 5,905 in Q1 25. The
average US sales force was steady at 15 FTE against Q1 25.
The sales force efficiency metric fell to 379 tests per sales FTE down from 403 in the prior
quarter, consistent with the lower US volumes. Tests per unique ordering clinician (our
preferred metric for measuring customer commitment to Cxbladder) was down slightly to 6.4
in Q2 25 from 6.8 in Q1 25 reflecting the lower volume (ordering clinicians were slightly higher
at 890).

Asia Pacific volumes were up 6.2% to 1,363 tests from 1,283 in Q1 25 reflecting a lift in volume
in New Zealand and growing, albeit still small volumes, from Australia and our distributors in
Asia.
Group total test volumes for the half year (1H 25) were down 22% to 14,233 from 18,240 in 1H
24, the period just ahead of Pacific Edge undertaking a reorganization to reduce the size of the
sales team to preserve cash to weather the Medicare uncertainty.
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.

---

INSIDE
Letter from the CEO 2
Q2 25 test volumes 3
Detect
+
pricing 5
AUA guideline review 5
2024 Annual Shareholders Meeting 6
New clinical utility evidence 7
Global expansion 8
Clinical study program update 9
OCTOBER 2024

PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2024
2
LETTER FROM THE CEO
A PATH TO MEDICARE
COVERAGE CERTAINTY
Dear Shareholders,
I was pleased to see so many of
you at our annual meeting last
month.
The Auckland venue was
packed with nearly 80 attending in
person. A further 230 people joined
online, making it one of the busiest
meetings our registrar, MUFG
Corporate Markets, has hosted
this year.
The strong attendance and
insightful questions received
highlighted the value of this forum
in helping shareholders better
understand our strategy and the
progress we’re making. It also
reaffirmed the strong support and
interest we enjoy from shareholders
for our vision and the potential of
our technology even in the face
of the continued uncertainty over
Medicare coverage of our tests.
Despite the tremendous
progress that we are making, the
test volumes we report today are
a reminder of the challenge the
draft ‘Genetic testing for oncology’
local coverage determination
(LCD) from Novitas, our Medicare
Administrative Contractor (MAC),
has presented to the company.
Total laboratory throughput
was lower on the prior quarter
again reflecting the challenges
we have seen over the last few
periods. The reduction in our sales
team following the reorganization
in the prior financial year and
our decision to limit backfilling
positions has reduced the reach
of our sales force. Against this we
have continued to benefit from
sales force efficency improvements,
a lift in volume from New Zealand
and sustained demand from Kaiser
Permanente.
During the meeting I was asked
about my outlook for the remainder
of the year and I noted there
were more catalysts for positive
progress than headwinds that could
negatively affect the business.
“...we have charted
a path to greater
certainty regarding the
Medicare coverage for
our future products.”



Firstly, we see the potential
for the American Urological
Association to use language
supportive of Cxbladder in the new
microhematuria guideline following
the review process that is now
underway (see page 5).
We remain confident that
Cxbladder Detect
+
will achieve a
price that will deliver a greater
margin and marginal percentage
than the current generation
of products, underpinning our
drive towards long term financial
sustainability. As we detail on
page 5, just after our annual
meeting, the Centers for Medicare
and Medicaid Services (CMS)
published their provisional pricing
recommendations and agreed with
the Pricing Panel that gapfilling
Detect
+
was more appropriate
due in its view to the absence of
suitable crosswalk candidates in
CMS Clinical Lab Fee Schedule.
With the review and comment
period on the decision now open,
we will continue our dialogue
with CMS to better understand
its rationale, as we maintain that
suitable crosswalk candidates exist.
Nevertheless, to keep our Detect
+

launch plans on track, we will take
the necessary steps with Novitas to
determine a provisional price while
we follow the alternative gapfill
process.
Finally, while Novitas continues
to review the draft LCD we believe
the environment is now more
favorable for Pacific Edge given the
publication of the STRATA
1
study
on the clinical utility of Triage and
its reception within the broader
urology community

(see page 5).
Furthermore, we have informed
Novitas of our latest publication
in the journal ‘Diagnostics’ on the
Analytical Validation of Triage,
Detect and Monitor that was
developed after a recent update to
our protocols
2
.
These catalysts need to be
balanced against the possibility
of a non-coverage determination
and - in the event of such a
1
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. The Journal of Urology Vol 212 1-8 Jul 2024.
2
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.

determination - possible negative
physician or patient response to
our enhanced patient responsibility
reimbursement initiatives.
However, as I noted at the
meeting, we have weathered this
uncertainty for over two years
and irrespective of the immediate
Novitas decision we have charted a
path to greater certainty regarding
Medicare coverage for our future
products.
Following the annual meeting,
the Board and the senior
management team met for two
days to discuss the long-term
strategy for the company. Even
prior to that session it was clear
to us that the choices we make in
the short term are contingent on
the Novitas decision on whether to
finalize, retire or start over on the
LCD, but the long term objectives
to transform the standard of
care in urology for hematuria
evaluation and the surveillance for
bladder cancer recurrence remains
unchanged.
We believe that we are on the
right path of evidence generation
which should deliver the coverage
certainty from Medicare and
other healthcare payers for
both our existing and our next
generation tests that is needed to
appropriately support sustained
future growth. We have therefore
agreed to develop a plan for
growth subject to key milestones
and advance key elements of that
plan even in the event of a negative
determination. We will update
shareholders when the path is clear.
Before closing I want to echo the
tributes Directors made to Chris
Gallaher as he presided over what
we expect to be his last annual
meeting. He has provided strong
leadership for the company through
a period of considerable change.
I also want to thank Independent
Director Mark Green who stepped
down from the Board at the
conclusion of the meeting. Mark has
provided consistent insight that has
challenged management to get the
best outcomes for the company.
I look forward to updating you
on our progress over the coming
months on what I expect to be an
important period for the company.
Best regards,
Dr Peter Meintjes
Chief Executive
PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2024
3
LETTER FROM THE CEO CONTINUED
Tests processed through our laboratories in the three months to the end of September 2024 (Q2 25)
were slightly lower on the prior quarter (Q1 25).
CMS’ July 2024 decision to grant an extension to Novitas on its deliberations over Medicare
coverage of our tests and the uncertainty associated with the extension added to the challenges faced
by the sales team. However, continuing strong demand from our US customer Kaiser Permanente, the
sustained benefits of our sales force efficiency gains and a lift in volume in the APAC region diluted the
impact of these factors.
Total laboratory throughput (TLT) in Q2 25 fell 2.0% to 7,045 tests, a figure slightly down on the 7,188
tests in Q1 25. US TLT was 5,682 tests down 3.8% on the 5,905 in Q1 25. The average US sales force was
steady at 15 FTE against Q1 25. The sales force efficiency metric fell to 379 tests per sales FTE down from
403 in the prior quarter consistent with the lower US volumes. Tests per unique ordering clinician (our
preferred metric for measuring customer commitment to Cxbladder) was down slightly to 6.4 in Q2 25
from 6.8 in Q1 25 reflecting the lower volume (ordering clinicians were slightly higher at 890).
Asia Pacific volumes were up 6.2% to 1,363 tests from 1,283 in Q1 25 reflecting a lift in volume in New
Zealand and growing, albeit still small volumes, from Australia and our distributors in Asia.
Group total test volumes for the half year (1H 25) were down 22% to 14,233 from 18,240 in 1H 24, the
period just ahead of Pacific Edge undertaking a reorganization to reduce the size of the sales team to
preserve cash to weather the Medicare uncertainty.
TEST VOLUMES
SALES SLIGHTLY DOWN FOR Q2 25

-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
Q2 22
4,706
1,074
5,780
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
1,363
7,045
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
1,283
7,188
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)
Q2 22
690
Q3 22
741
Q4 22
789
Q1 23
895890
Q1 25
869
Q2 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
6.8
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)
202
160
187
222
226
201
239
288
265
23
Q2 22
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
292
5.9
6.7
381
6.8
6.4
379
403
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
Q2 22
4,706
1,074
5,780
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
1,363
7,045
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
1,283
7,188
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)
Q2 22
690
Q3 22
741
Q4 22
789
Q1 23
895
890
Q1 25
869
Q2 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
6.8
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)
202
160
187
222
226
201
239
288
265
23
Q2 22
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
292
5.9
6.7
381
6.8
6.4
379
403
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
Q2 22
4,706
1,074
5,780
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
1,363
7,045
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
1,283
7,188
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)
Q2 22
690
Q3 22
741
Q4 22
789
Q1 23
895890
Q1 25
869
Q2 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
6.8
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)
202
160
187
222
226
201
239
288
265
23
Q2 22
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
292
5.9
6.7
381
6.8
6.4
379
403
7,816
FIGURE 1: TOTAL TEST VOLUMES
1
FIGURE 2: CXBLADDER CLINICAL ADOPTION
FIGURE 3: US SALES FORCE EFFICIENCY
TEST VOLUMES CONTINUED
PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2024
4
1
Volumes in some prior quarters of FY24 are marginally different from those reported in earlier investor updates reflecting post period adjustments.

CMS PROPOSES ‘GAPFILL’ PRICING FOR DETECT
+
DETECT
+
COMMERCIALIZATION
PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2024
5
With the Centers for Medicare & Medicaid Services (CMS) preliminary determination last month to pursue the
gapfill process to establish a price for the test, Pacific Edge is focused on launching Detect
+
in 2025 subject to key
reimbursement and pricing milestones.
In its draft pricing document CMS stated: “there are no existing codes on the CLFS
1
with similar methods
or resources. By gapfilling this code, the resources used in this code can be better estimated by a Medicare
Administrative Contractor (MAC)”.
The proposal to gapfill emphasizes the novelty of Detect
+
, as the process is most appropriate for novel
technologies, novel combinations of technologies or novel clinical applications. The gapfill process will see all MACs
providing a price to CMS, which then sets a price based on those submissions.
Pacific Edge will use the Notice and Comment period that now runs until the end of October to connect with
CMS to understand its reasoning, prepare for gapfill in 2025, and work with Novitas on provisional pricing options to
ensure no disruption to our Detect
+
launch plans.
Our goal will be to ensure Detect
+
comes to market with a price that recognizes its clinical and economic value in
both safely sparing patients at a low risk of bladder cancer from invasive examinations and identifying those patients
with an elevated risk of bladder cancer and requiring a more thorough clinical workup. Pacific Edge will use the
existing crosswalk logic as the starting point for establishing a provisional price with Novitas and gapfill discussions
with all MACs.
The provisional price we achieve with Novitas and the final gapfill price set the amount Pacific Edge will be
reimbursed for all patients with Medicare and Medicare Advantage insurance (subject to coverage). It also sets a
benchmark for non-contracted reimbursement and contracting negotiations to determine the price that other US
health insurance companies will reimburse for tests.
AUA SEEKS HEMATURIA GUIDELINE PEER REVIEW
AUA GUIDELINES INCLUSION
Pacific Edge is awaiting the outcome of the American Urological Association (AUA) review of its microhematuria
guidelines now underway. The outcome of the review, the first since 2020, has the potential to exert considerable
influence over the adoption of Cxbladder in the US.
A draft of the revised guideline was made available to AUA members last month under strict conditions of
confidentiality for peer review. Finalization of the standard and publication is expected in the coming months.
Positive language endorsing the use of Cxbladder would further validate the clinical value of our tests in the
evaluation of patients with microhematuria. It could also drive changes in the medical and reimbursement policies of
healthcare payers, change clinical practice and drive the adoption of our tests.
Notably, favorable product-specific language would have the effect of driving medical policy, including Medicare
coverage of Cxbladder, or be used as the basis for a reconsideration request to Novitas, in the event of a non-
coverage determination.
Pacific Edge Chief Medical Officer Dr Tamer Aboushwareb is contributing to the AUA’s peer-review consultation
on the guideline under the terms of a strict and personal AUA confidentiality agreement that prohibits the disclosure
of the draft to Pacific Edge.
The review follows the publication of our STRATA
1
study in the Journal of Urology. As a randomized controlled
trial of the test - the first study of this kind for a urine biomarker for hematuria evaluation - STRATA has delivered
the evidence that meets the standard typically required for guideline committees to consider a change to standards
of care. The guidelines review also
follows the publication of an editorial in
the Journal of Urology in September
2

supporting the use of Cxbladder to
reduce unnecessary cystoscopies and
clinicians to evaluate patients both
presenting with hematuria and those
under surveillance for bladder cancer
recurrence.
1
CMS Clinical Lab Fee Schedule
1
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. The Journal of Urology Vol 212 1-8 Jul 2024
2
Anderson (2024). The Future of Cystoscopy for Detecting Urothelial Carcinoma Vol. 212, 399-400, September 2024.

PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2024
6
CXBLADDER ADOPTION IN FOCUS AT OUR
ANNUAL MEETING
ANNUAL SHAREHOLDERS MEETING
Mr Gallaher, who agreed in August to remain as
Chairman during a transition to a successor in the
coming year, made the comment as he recounted the
journey of a friend in Melbourne who had endured
fifty-two cystoscopies in his battle with recurrent
bladder cancer. However, his friend could not use
Cxbladder to reduce the burden of the examinations
because the test – despite the wealth of evidence – was
not yet included in Australian standards of care.
“It is not enough to have a very good test, we must
also have the test that urologists will adopt and use,”
Mr Gallaher told the meeting.
This call to action framed the meeting’s central
theme—driving adoption of Pacific Edge’s bladder
cancer diagnostic tests.
Chief Executive Dr Peter Meintjes reviewed
FY24 full-year performance and set out the steps
the company was taking to secure coverage of the
company’s tests by Medicare, the single largest
contract globally for Cxbladder. These steps included
prudent management of cash reserves, engagement
with industry and clinical key opinion leaders and the
company’s clinical evidence generation program.
Pacific Edge Diagnostics USA President David
Levison detailed the path to commercialization of
Cxbladder Detect
+
and Monitor
+
, the next-generation
tests. He also highlighted how digital tools – like the
customer portal and IT system integrations with Kaiser
Permanente and Lumea – enhance user experience and
drive loyalty and market share.
Dr Meintjes, standing in for Chief Medical Officer
Dr Tamer Aboushwareb, gave an overview of how our
clinical evidence program drives changes in clinical
practice, payer reimbursement policies, and care
guidelines. He also outlined how our ongoing studies –
DRIVE, microDRIVE, AUSSIE, LOBSTER, and CREDIBLE
– would provide the necessary evidence to embed
Cxbladder in clinical guidelines, secure payer coverage,
and support new test commercialization.
“We are giving people a better quality of life,” Pacific Edge Chair Chris Gallaher told the company’s Annual
Shareholders Meeting in Auckland last month as he reflected on his near nine years at the helm of the company
and his confidence in its future.
FOR FULL MEETING DETAILS, INCLUDING
MR. GALLAHER’S SPEECH, VISIT:
https://www.pacificedgedx.com/investors/
investor-center/

REAL WORLD EVIDENCE
KAISER REPORTS ON REAL WORLD UTILITY OF
CXBLADDER IN NEW ABSTRACT
Southern California Permanente Medical Group (KP SoCal) is experiencing the benefits from deploying
Cxbladder Triage in a consistent clinical pathway.
In an abstract covering the results of a large clinical study that will be presented to the Western Section of
the American Urological Association (WSAUA) later this month, KP SoCal has detailed how it is using Cxbladder
Triage to improve the evaluation of patients presenting with hematuria.
The authors of the abstract said: “Incorporating a highly reliable urine biomarker into clinical workflows for
hematuria reduced the burden of cystoscopy substantially, improving patient satisfaction, urology access, and
lowering overall cost of care.”
Real world evidence such as the Kaiser Permanente study and those underway in Australia (see page 8)
supports the adoption of Cxbladder into clinical practice. The findings demonstrate how healthcare providers like
Kaiser Permanente are using it to improve patient care, streamline workflows, and reduce costs.
Real world evidence is the ideal complement to the clinical utility evidence generated from our core evidence
generation program and this is particularly the case with the Kaiser Permanente study as it independently
demonstrates the clinical utility of Cxbladder in a US population, our largest market.
Kaiser Permanente is working toward a peer reviewed publication based on the complete data to be published
in time for the AUA conference next year and, in the event of a Medicare non-coverage determination, the study
will be used as a basis for a coverage reconsideration request.
The study involved 1,563 low-risk patients with no history of gross hematuria or those who declined
cystoscopy. It showed that 1200 or 77% of the patients tested, were able to avoid an invasive cystoscopy. This not
only boosted patient satisfaction but also improved access to urological care by freeing up resources and time for
other patients. Of the 363 patients flagged as high-risk, 310 underwent cystoscopy, leading to 19 confirmed cancer
diagnoses (6.1%).
PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2024
7
1,563
Low-risk patients took a
Cxbladder Triage test
Patients:
- Had no history of
gross hematuria; or
- Refused cystoscopy
1,200 (77%)
NEGATIVE
Avoided a
cystoscopy
363 (23%)
POSITIVE
Identified as
‘high-risk’ of cancer
310
Underwent a
cystoscopy
19
Diagnosed with
cancer (6.1% of those
examined)
CLINICAL UTILITY: PRELIMINARY RESULTS OF THE KAISER STUDY

GLOBAL EXPANSION
PACIFIC EDGE ON THE PODIUM AT UAA IN BALI
Dr Prasanth Anton Sagayanathan from the Sunshine Coast University Hospital presented preliminary
results from his study demonstrating the clinical utility of Cxbladder detecting bladder cancer in a Far
North Queensland population. Meanwhile, Dr Arjun Guduguntla of Northern Health in Melbourne presented
preliminary data on a proposed novel surveillance schedule using Cxbladder Monitor for patients on annual
bladder surveillance.
Finally, Pacific Edge Chief Executive Dr Peter Meintjes presented data from the groundbreaking STRATA
study
1
, the first time clinical utility evidence from the randomized controlled trial has been presented to an
APAC audience.
Prior to the activities at the UAA
Congress Dr Meintjes visited Malaysia for
a ceremonial signing of a lab partnering
agreement with Premier Integrated Labs.
The event was supported by New Zealand
Trade and Enterprise and attended by
the Prime Minister, the Right Honourable
Christopher Luxon. Premier Integrated
Labs is the sole supplier of laboratory
services to Malaysia’s IHH Healthcare,
which operates the three largest
individual hospitals in Malaysia. This
partnership represents a further advance
of Pacific Edge’s strategy to expand
the availability of Cxbladder across key
international markets.
PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2024
8
1
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. The Journal of Urology Vol 212 1-8 Jul 2024.
New evidence of Cxbladder’s clinical utility was presented to the Urological Association of Asia (UAA)
in early September.
Ceremonial signing of partnership agreement with Malaysia’s Premier Integrated
Labs in Kuala Lumpur
Australia
Singapore
Philippines
Hong Kong
MalaysiaBrunei
Vietnam
Thailand
Israel
Argentina
Uruguay
Venezuela
United States
New Zealand
Pacifc Edge
Diagnostics USA,
Hershey, PA
Pacific Edge HQ,
Dunedin
Commercial
— direct sales team
Commercial
— distribution partners
PACIFIC EDGE’S GLOBAL OPERATIONS

CLINICAL EVIDENCE PROGRAM
EVIDENCE TO DRIVE CLINICAL PRACTICE CHANGE
STUDYGOALPOPULATION AND
USE
STATUS
STRATA
(Safe Testing of Risk
for AsymptomaTic
MicrohematuriA)
•
CU for T
riage
•
CU for Det
ect
+
(retrospective)
•Microhematuria
(MH)
•Risk stratification
- Recruitment closed with 555 patients
including 223 low risk patients (test and
control) and interim analysis results
published in Journal of Urology
- Data cleaning for the final analysis was
completed mid-Aug. The database lock
is scheduled mid-Dec 2024 and the
final
Clinical Study Report (CSR) June 2025.
DRIVE
(D
etection and Risk
stratification In VEterans
presenting with
hematuria)
•CV for Detect
+
•CV for Triage for a
Veterans’ cohort
•Data for 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
VA sites
-
Projections are for database lock mid-Nov
24 and publication submitted Q1 25
microDRIVE
(Detection and Risk
stratification In VEterans
presenting with
hematuria)
•CV of Det
ect
+
•Data for pooled
analysis
•MH
•Detection
-This is a network study across all VAMCs
coordinated from a single US VA
-358 patients have consented for the study
with 152 samples received to date
-The target is 1000 patients with 35-50
tumour confirmed patients
-Last patient in is now projected to be Q2 25
AUSSIE
(Australian Urologic risk
Stratification of patientS
wIth hEmaturia)
•
CV of Det
ect
+
(Australian
cohort)
•Data for pooled
analysis
•MH and GH
•Risk str
atification
-
Tar
get enrolment: 600 patients across
a
t
least three Australian sites
-264 subjects are enrolled to date, including
15 UC confirmed (target is 35)
-Last patient in is projected for Q2 25
POOLED ANALYSIS•
CV of Detect
+
•MH and GH
•Risk stratification
-MH and separately GH patient data from
DRIVE, AUSSIE, and microDRIVE will be
pooled and performance determined
-Paper submissionis one quarter after
publication of DRIVE, microDRIVE and
AUSSIE
LOBSTER
(LOngitudinal Bladder
cancer Study for
Tumor Recurrence)
•CV of Monitor/
Monitor
+
•Surveillance
•Risk stratification
-Enrolment will complete once 75 UC
recurrences have been observed across
8-10 sites
-Enrolment is now 364 subjects providing
654 samples with 38 UC recurrences
observed to date
-
Expected completion is mid 2025
CREDIBLE
(Cystoscopic REDuction
In BLadder Evaluations
for microhematuria) - A
randomized, controlled,
clinical utility study for
hematuria evaluation
•
CU of Detect
+
•MH
•Risk stratification
-Protocol approved by Specialty Networks
central IRB and 4 of 15 sites contracted
-An interim analysis will be conducted at
600 subjects to determine if incidence is
<5% tumours and if so, will continue to
1000 are enrolled
-
Enrolment due to commence Dec-2024
*Dates are calendar year not financial years
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 that is founded on the frameworks of
Analytical Validity, Clinical Validity, and Clinical Utility, with the end points and sample sizes required for coverage
decisions and guideline inclusion.
PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2024
9

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 Zealandd
T: 0800 555 563 (NZ)
+64 3 577 6733 (Overseas)
E: investors@pacificedge.co.nz