Q1 26 Cxbladder Demand Resilient Despite Coverage Loss

14 JULY 2025



CXBLADDER DEMAND RESILIENT DESPITE COVERAGE LOSS
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today
reports resilient demand for its tests in the three months to the end of June 2025 (Q1 26)
despite to loss of Medicare coverage in April 2025 and the disruption caused from the transition
of US customers from Detect to Triage.
The company also reports positive discussions with Medicare Administrative Contractor
Novitas following Pacific Edge lodging a Medicare reconsideration request based on evidence
not considered in the review that led to the non-coverage decision. The new evidence includes
the ground-breaking STRATA
1
randomized control study demonstrating the clinical utility of
Cxbladder Triage and the new AUA microhematuria guideline.
US TLT in Q1 26 was down 11.9% to 5,717 tests from 6,490 in Q4 25 with the drop in volumes
largely due to the disruption of asking physicians to switch from Cxbladder Detect to Triage for
hematuria evaluation. Pacific Edge accelerated the decision to discontinue Detect in the US
market following the inclusion of Triage in the new American Urological Association
Microhematuria guideline and the non-coverage determination.
Cxbladder Triage represented around 77% of US TLT in June 2025 up from 22% in Q4 25, the
quarter prior to the decision to discontinue Detect. Meanwhile, Detect tests received for
processing (which our customer service attempts to transition to Triage tests with clinician
approval) made up only 6% of all tests received for the month of June 2025, down from the
59% received in Q4 25 the last quarter before the determination became effective.
Total laboratory throughput (TLT) in Q1 26 fell 8.9% to 6,900 from the 7,577 tests in Q4 25.
Our sales force efficiency metric in Q1 26 was 381 compared to 406 tests per sales FTE in Q4
25 reflecting the disruptions caused by switching customers from Detect to Triage, which
requires additional patient information.
The requirement to provide an advanced beneficiary notice (ABN) with a Cxbladder Monitor
test has also impacted volumes, but insulates the company from running unpaid tests, because
the ABN informs the patient they may be held financially responsible for the test if Medicare
denies payment. Tests per unique US ordering clinician (our preferred metric for measuring
customer commitment to Cxbladder) were 6.3, down from the 7.1 tests in Q4 25.
Meanwhile, the volumes from our key contracted US customers such as Kaiser Permanente
are unaffected by the determination.
Asia Pacific volumes were up 8.8% to 1,183 from 1,087 in Q4 25, a move that reflected volume
growth in all markets; Australia Southeast Asia and New Zealand.
The Q1 26 investor update also covers:

2

• The publication of data demonstrating the Analytical Validation of Triage Plus in
Diagnostics
2
. This publication is one of two pieces of clinical evidence Pacific Edge
requires to support a reconsideration request from Novitas regarding the Medicare
coverage of Triage Plus
• A preview of the company’s annual meeting on 6 August 2025 in Auckland and the
detail of the company’s ~$21 million capital raising.

Released for and 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 suite of non-invasive genomic urine tests optimized for the risk stratification of
urothelial cancer in patients presenting with microhematuria and those being monitored for
recurrent disease. The tests help improve the overall patient experience, while prioritizing time
and clinical resources to optimize practice workflow and improve efficiency.
Supported by over 20 years of research, Cxbladder’s evidence portfolio extends to more than
25 peer reviewed publications, and Cxbladder Triage is now included in the American
Urological Association’s Microhematuria Guideline. To drive increased adoption and improved
patient health outcomes, Cxbladder is the focal point of numerous ongoing and planned studies
designed to generate further clinical utility evidence.
Cxbladder is available in the US, Australasia, and Israel and in markets throughout Asia and
South America. In the US, the test has been used by over 5,000 urologists who have ordered
more than 130,000 tests. In New Zealand, Cxbladder is accessible to around 70% of the
population via public healthcare and all residents have the option of buying the test online.

3

---

JULY 2025
INVESTOR UPDATE
INSIDE
Letter from the CEO 2
Q1 26 test volumes 3
Capital raising overview 5
Annual meeting preview 5
Triage Plus analytical validation 6
Clinical evidence program 7

Dear Shareholders,
Pacific Edge enters FY 26 leaning into the
opportunities created with the company-defining
milestone of Cxbladder’s inclusion in the American
Urological Association’s microhematuria guideline in
February 2025. The guideline has cemented our position
as the best-in-class provider of tests for hematuria
evaluation and surveillance of non-muscle invasive
bladder cancer patients both in the US and further afield.
The guideline, when combined with the new
publications from our evidence generation
program, is shifting clinical sentiment
towards the adoption of our tests. As
the only product with a ‘Grade A’
1

evidence rating in the guideline, we
have expanded the moat around
our business, strengthening our first
mover advantage as we seek to regain
Medicare coverage for our tests.
The clearest evidence of this
sentiment shift, as detailed on
page 6, is the way US customers
have transitioned to Cxbladder Triage
for hematuria evaluation — with Triage
accounting for 77% of US tests in June, up
from 22% in Q4 FY 25. We accelerated the transition
of US customers to Triage after the non-coverage on
the ‘Genetic Testing for Oncology: Specific Tests’ Local
Coverage Determination (LCD) (L39365) ended Medicare
coverage of our tests. Moving to Triage better prepares
our customers for the future update to Triage Plus when
we receive coverage for that test at a higher price.
We are in the midst of a capital raise, in which $16.1
million has already been pledged to the company from
the placement offer in May 2025. We are intending to
seek $5 million (with over subscriptions possible with
Board approval) through the associated share purchase
plan (SPP
2
). These funds will extend the cash runway for
over 12 months without Medicare coverage and without
reductions in our cost base that would undermine
our core priorities. The placement, which is subject
to shareholder approval at the Annual Shareholders’
Meeting (ASM) in August, and funds raised through the
SPP will also support our goal to regain coverage and
grow in non-Medicare channels.
The AUA guideline has allowed us to view the non-
coverage determination differently, not least because it
offers a clinically validated and authoritative reason for
clinicians to continue to order our tests, for healthcare
providers to integrate Cxbladder into clinical pathways
and for payers to pay for medically reasonable and
necessary testing.
As we navigated the negative market messaging
from loss of Medicare coverage, and the operational
logistics of converting all customers over to Triage, the
test volumes in this quarter are yet to show the effect of
the AUA guideline inclusion (see page 3-4), but we are
advancing a range of initiatives to achieve this goal.
We continue to leverage the AUA guideline to
appeal all Medicare denials for Triage and
anticipate payment on these tests through
that process
3
.
Similarly, we continue to appeal all
commercial payer denials for Triage,
moving quickly to “external review” to
drive payment and create opportunities
for contracting. We have also initiated a
pilot program to establish ‘Client Billing’
as a practice, leveraging the ‘in-network’
status many of our larger customers enjoy
with commercial payers.
These initiatives — enabled by the
AUA guideline inclusion — are still in the early
stages but represent a significant potential pathway
to expand adoption and drive revenue as part of our
broader commercial payer strategy. We have already
had contracting wins with the Blue Cross Blue Shield
Group Purchasing Organization, gained a favorable
recommendation from ECRI
4
– a data curator to which
many commercial payers subscribe, and we are in
numerous conversations for positive medical policy with
the larger commercial payers. We ended the quarter with
a win by securing ‘in-network’ status with Optum Veterans’
Affairs Community Care Network (VACCN). The Optum
VACCN covers healthcare costs for the VA for veterans
across the eastern and central US who are unable to get a
timely appointment within a VA facility and will pay Pacific
Edge for Cxbladder at the Medicare rate.
Our efforts to regain Medicare coverage continue. In
March 2025 we lodged a reconsideration request based
on evidence not considered in the review that led to
the non-coverage LCD. The new evidence includes the
ground-breaking STRATA
5
randomized control study
demonstrating the clinical utility of Cxbladder Triage and
the new AUA microhematuria guideline.
LETTER FROM THE CEO
Maintaining the momentum
established through guideline
inclusion
“...now we
must focus on
scalable and
profitable growth
in sales to increase
shareholder

value.”
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
No offer of new shares is made under the SPP unless and until Pacific Edge sends the SPP offer document to shareholders. No money is currently being sought,
and new shares cannot currently be applied for or acquired under the SPP.
3
For a description of the Medicare appeals process please refer to our Annual Report published on 30 June 2025.
4
ECRI is the Emergency Care Research Institute https://home.ecri.org/
5
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.

On June 26, 2025 (US time) we met with Novitas
6

Medical Affairs to discuss the reconsideration request we
had made for Triage in March. The conversations were
thorough and engaging, with the Novitas team noting
that they had familiarized themselves with the AUA
microhematuria guideline ahead of our call. The Novitas
team made it clear that they understood how our test
could deliver clinical utility to physicians and economic
utility to insurers and expressed their commitment to
provide medically reasonable and necessary testing
to the Medicare population. They discussed with us
the precise indications for coverage, focused on how
physicians select patients for Triage testing. The 2020
and 2025 AUA Guidelines, the Kaiser Abstract from the
AUA, and our STRATA publication clearly identify those
patient types, and Novitas gave a non-binding verbal
indication that our evidence was compelling for the
purposes of re-opening the LCD.
We have a second meeting with Novitas on July 17
to discuss the reconsideration request for Cxbladder
Monitor that we submitted in May, and we look forward to
submitting a request later this year for Medicare coverage
of Triage Plus, when the Analytical Validation (published
8 July 2025 online in Diagnostics
7
) and Clinical Validation
(DRIVE study, in peer review) are published. We note that
the Medicare Program Integrity Manual allows Novitas
to combine reconsideration requests together when
opening an LCD and overlapping submissions may affect
the previously estimated timelines.
Pacific Edge’s success with these strategies
substantially depends on the shareholder approval
of the placement and support for the $5 million SPP.
Shareholders will shortly receive the receive the SPP
documentation, and the Notice of our ASM (NOM) to be
held in Auckland on 6 August 2025. The NOM will detail
the approvals Pacific Edge requires and rationale for
each of them.
I encourage you to consider these documents carefully
and to support the company through what stands to be a
key period in its development.
While the loss of Medicare coverage in April was
disappointing, inclusion in the AUA Guideline and the
positive attitude of payers including Novitas to that
milestone gives me the confidence that we have already
achieved what’s necessary for enduring coverage of
Cxbladder Triage and that now we must focus on scalable
and profitable growth in sales to increase shareholder value.
I look forward to seeing you all at our meeting in
August.
With my warm 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 June 2025 (Q1 26)
and test demand have been resilient in the face of the Medicare non-coverage determination and the disruption
caused from the transition from Detect to Triage.
US TLT was down 11.9% to 5,717 tests from 6,490 in Q4 25 with the drop in volumes largely due to the
disruption of asking physicians to switch from Cxbladder Detect to Triage for hematuria evaluation. Pacific Edge
accelerated the decision to discontinue Detect in the US market following the inclusion of Triage in the new
American Urological Association Microhematuria guideline and the non-coverage determination became effective.
Cxbladder Triage represented around 77% of US TLT in June 2025 up from 22% in Q4 25, the quarter prior to
the decision to discontinue Detect. Meanwhile, Detect tests received for processing (which our customer service
attempts to transition to Triage tests with clinician approval) made up only 6% of all tests received for the month
of June 2025, down from the 59% received in Q4 25 the last quarter before the determination.
Total laboratory throughput (TLT) in Q1 26 fell 8.9% to 6,900 from the 7,577 tests Q4 25.
Our sales force efficiency metric or Q1 26 was 381 compared to 406 tests per sales FTE in Q4 25 reflecting the
disruptions caused by switching customers from Detect to Triage, which requires additional patient information.
The requirement to provide an advanced beneficiary notice (ABN) with a Cxbladder Monitor test has also
impacted volumes, but insulates the company from running unpaid tests, because the ABN informs the patient
they may be held financially responsible for the test if Medicare denies payment. Tests per unique US ordering
clinician (our preferred metric for measuring customer commitment to Cxbladder) were 6.3, down from the 7.1
tests in Q4 25.
Meanwhile, the volumes from our key contracted US customers such as Kaiser Permanente are unaffected by
the determination.
Asia Pacific volumes were up 8.8% to 1,183 from 1,087 in Q4 25, a move that reflected volume growth in all
markets; Australia Southeast Asia and New Zealand.
TEST VOLUMES
Test demand resilient despite Medicare coverage loss
3
6
Novitas is the Medicare administrative contractor with responsibility for our US laboratory.
6
Harvey, J.C. et al. (2025) Analytical Validation of the Cxbladder® Triage Plus Assay for Risk Stratification of Hematuria Patients
for Urothelial Carcinoma. Diagnostics 2025, 15, 1739.

-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
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
Q1 26
5,717
1,183
6,900
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)
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
6.8
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)
222
226
201
239
288
265
27
303333
30282115151515
907
292
5.9
6.7
6.8
403
379
6.4
6.7
379
6.3
Q4 25Q1 26
Q1 23

Q2 23Q3 23Q4 23Q1 24Q2 24
Q3 24Q4 24Q1 25Q2 25Q3 25Q4 25
Q1 26
1616
381381
406
7.1
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
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
Q1 26
5,717
1,183
6,900
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)
Q1 23
895
890866
Q1 25
867
Q2 25Q3 25
Q2 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
6.8
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)
222
226
201
239
288
265
27
303333
30282115151515
907
292
5.9
6.7
6.8
403
379
6.4
6.7
379
6.3
Q4 25Q1 26
Q1 23

Q2 23Q3 23Q4 23Q1 24Q2 24
Q3 24Q4 24Q1 25Q2 25Q3 25Q4 25
Q1 26
1616
381381
406
7.1
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
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
Q1 26
5,717
1,183
6,900
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)
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
6.8
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)
222
226
201
239
288
265
27
303333
30282115151515
907
292
5.9
6.7
6.8
403
379
6.4
6.7
379
6.3
Q4 25Q1 26
Q1 23

Q2 23Q3 23Q4 23Q1 24Q2 24
Q3 24Q4 24Q1 25Q2 25Q3 25Q4 25
Q1 26
1616
381381
406
7.1
7,816
FIGURE 1: TOTAL TEST VOLUMES
FIGURE 2: CXBLADDER CLINICAL ADOPTION
FIGURE 3: US SALES FORCE EFFICIENCY
FIGURE 4: US TESTS RECEIVED AND TEST MIX
TEST VOLUMES CONTINUED
4
0%
10%
20%
30%
40%
50%
60%
70%
80%
% of Tests Received
Tests Numbers
Monthly Average Q4 25Apr 25May 25Jun 25
2,147
2,306
1,772
1,804
59%
23%
52%
29%
60%
21%
6%
74%
-
500
1,000
1,500
2,000
2,500
Tests Received STUDY Triage Plus Triage Monitor Detect

CAPITAL RAISING
5
Major shareholders back capital raise
Pacific Edge has received strong support from institutional investors in the first phase
of its capital raise that is targeted at sustaining the company’s commercial momentum,
advancing its next-generation product pipeline, and regaining Medicare coverage for its
Cxbladder tests.
The $16 million raised through a placement of new shares to institutional and other
selected investors, exceeded the initial $15 million target after the Board accepted
oversubscriptions.
The placement, which is subject to shareholder approval at the company’s annual
meeting in August, is priced at $0.10 per share — an 18% premium to the 20-day volume
weighted average price (VWAP) up to and including 29 May 2025 (the day prior to the
public announcement of the capital raising through the NZX and ASX).
The second phase of the capital raising — a $5 million Share Purchase Plan (SPP) to be
offered to eligible retail shareholders at the same price — is expected to open in mid-July
and is contingent on the placement becoming unconditional.
1
We are encouraged by the strong support we have received from our institutional
shareholders, which reflects recognition of the value we have created in the face of the
significant challenges of the last year. The capital will help us maintain our momentum
and ensure we are well-positioned to respond strategically to both challenges and
opportunities. We are looking forward to giving all eligible shareholders the opportunity to
participate at the same offer price as the placement.
A full agenda for Annual Shareholders’ Meeting
Pacific Edge is holding its Annual
Shareholders’ Meeting in Auckland on
Wednesday 6 August beginning at
3:00pm and we are looking forward
to seeing all our shareholders there.
Chairman Chris Gallaher and Chief
Executive Dr Peter Meintjes will provide a
strategic update at the meeting covering
the opportunities that have emerged
for the business since Cxbladder Triage
was included in the AUA microhematuria
guideline and the path to regaining
Medicare coverage of the company’s tests.
The meeting also has a full agenda of matters for shareholders to consider. These include the
re-election of Directors including Chris Gallaher, Sarah Park and Tony Barclay.
The meeting will also seek shareholder approval for the $16.1 million placement of shares to selected
shareholders and resolutions to approve an increase in the Directors fees pool. A key element of this
second proposal is that the first year of this increase is paid in shares rather than cash to support the
company’s ongoing need to preserve capital as it seeks to regain Medicare coverage. This share issue
will also be put to shareholders for approval.
Further details can be found in the Notice of Meeting to be mailed to shareholders imminently and
on the investor section of the website at: www.pacificedgedx.com/investors/investor-center/
Meanwhile we would appreciate shareholders signaling their attention to attending via the follow
Eventbrite link https://bit.ly/PacificEdgeASM2025
1
No offer of new shares is made under the SPP unless and until Pacific Edge sends the SPP offer document to shareholders.
No money is currently being sought and new shares cannot be applied for or acquired under the SPP.

1
Harvey, J.C. et al. (2025) Analytical Validation of the Cxbladder® Triage Plus Assay for Risk Stratification of Hematuria Patients for Urothelial
Carcinoma. Diagnostics 2025, 15, 1739. Also available at the following link: https://www.mdpi.com/2075-4418/15/14/1739
2
Novitas is the Medicare Administative Contractor with responsibility for Pacific Edge’s US laboratory.
3
For definitions Sensitivity, Specificity, Negative Predictive Value, and Positive Predictive Value please refer to glossary in the Capital raising
presentation released to the NZX and ASX on 29 May 2025. All values quoted are at a score threshold of 0.15.
Triage Plus analytical validation published
Triage Plus has moved a step closer towards commercial launch with the publication of its analytical
validation in Diagnostics
1
.
This publication is one of two pieces of clinical evidence Pacific Edge requires to support a reconsideration
request from Novitas
2
regarding the Medicare coverage of Triage Plus. The second element, the DRIVE study,
was submitted for peer review in June. If the reconsideration request is successful, that is the final hurdle before
commercialization of the test in the US.
In the AV publication Triage Plus demonstrated a sensitivity of 93.6%, specificity of 90.8%, positive
predictive value (PPV) of 46.5%, negative predictive value of 99.4%, and a test-negative rate of 84.1%
3
. The
study concluded: “Cxbladder Triage Plus... provides a non-invasive, highly sensitive, and reproducible tool that
aids in risk stratification of patients with hematuria.”
In addition to providing superior performance characteristics that will benefit
patients, clinicians, and healthcare payers, the test, once commercialized, is
expected to boost the economics of Pacific Edge’s US commercial operations.
The Centers for Medicare and Medicaid Services has set a draft price for the
test at US$1,018 — a substantial premium over the current US$760 price for
Triage. At this price, which is due to be finalised in January 2026, the margin
per test is higher and the profitability threshold lower than Triage, enabling
faster scaling and a quicker path to profitability.
6
TRIAGE PLUS COMMERCIALIZATION
“Triage Plus...
[is] a non-invasive,
highly sensitive,
and reproducible
tool that aids in risk
stratification.”

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 Triage
• CV/CU Triage Plus
(retrospective)
• Microhematuria
(MH)
• Risk stratification
• Recruitment closed with 555 patients including
223 low risk patients (test and control).
• Interim analysis results published leading to AUA
Guidelines inclusion in 2025 update.
• Database lock expected July 2025 and Clinical
Study Report (CSR) expected Oct 2025.
DRIVE
Detection and
Risk stratification
In VEterans
presenting with
hematuria
• CV Triage Plus for
a Veterans’ cohort
• Data MH pooled
analysis
• MH and gross
hematuria (GH)
• Risk stratification
• Enrolment closed with 710 patients including 48
tumour confirmed patients from 10 US VA sites.
• Database lock completed and publication
submitted June 2025.
microDRIVE
Detection and
Risk stratification
In VEterans
presenting with
microhematuria
• CV Triage Plus
• Data MH pooled
analysis
• MH
• Risk stratification
• Currently 254
1
samples received to date with 6
Urothelial Cancer (UC) cases confirmed including
matched samples.
• Study expanded to 4 active sites with 1-2 more
sites at feasibility assessment.
• The target is 1000 patients with 35 tumour
confirmed patients with LPI projected to be
delayed beyond Q4 2025 and more likely Q2
2026.
AUSSIE
Australian Urologic
risk Stratification
of patientS wIth
hEmaturia
• CV Triage Plus
(Australian
cohort)
• Data MH pooled
analysis
• MH and GH
• Risk stratification
• The target is 35 UC confirmed patients including
a minimum of 10 MH UC confirmed.
• Currently 704 subjects enrolled with 47 UC
confirmed (GH+MH) including 7 MH UC patients.
• Last patient in projected to be Q3 2025.
POOLED
ANALYSIS
• CV Triage Plus • MH and GH
• Risk stratification
• MH (and separately GH) patient data from DRIVE,
AUSSIE and microDRIVE will be pooled and
analyzed.
• GH paper submission is expected in 2026, and
MH pooled analysis is delayed due to microDRIVE
until at least Q2 2025.
LOBSTER
LOngitudinal
Bladder cancer
Study for
Tumor Recurrence
• CV Monitor and
Monitor Plus
• Surveillance
• Risk stratification
• Enrolment will be complete when 75 UC
recurrences are observed.
• Currently 454 subjects enrolled with 1,044
samples and 70 confirmed UC recurrences.
• We project last patient Q4-2025 and cleanup of
data to follow.
CREDIBLE
Cystoscopic
REDuction
In BLadder
Evaluations for
microhematuria
• CU Triage Plus

• MH
• Risk stratification
• Contracts completed (15/15), study level
Institutional Review Board (IRB) approvals and
site level IRB approvals (14/15).
• Site authorized to enroll (11/15), remainder due by
end of July.
• 8 sites are actively enrolling with 26 subjects
enrolled.
Quarterly dates are calendar year not financial years
7
1
This figure is smaller than the figure provided in the company’s 2025 annual report due to a revision subsequent
to its publication on 30 June 2025.

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