Q2 26 Cxbladder Volumes Weaken After Coverage Loss

14 OCTOBER 2025



CXBLADDER VOLUMES WEAKEN AFTER COVERAGE LOSS
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today
reports Cxbladder tests processed through its laboratories in the three months to the end of
September 2025 (Q2 26) have weakened amid the disruption caused by transitioning US
customers from Detect to Triage and the extra administrative processes faced by healthcare
payers and clinicians since the loss of Medicare coverage in April 2025.
The volume data is carried in the Q2 26 investor update, which also covers:
• Notification that the DRIVE Study, which demonstrates the clinical validity of Cxbladder
Triage Plus in a veterans’ population, has been accepted for publication in the Journal
of Urologic Oncology
1
. This publication provides the clinical validation evidence
necessary for us to formally request our Medicare Administrative Contractor Novitas to
consider coverage for Triage Plus.
• Further detail on Novitas’ decision to convene a panel of experts to discuss evidence
for the use of urine biomarkers in patients with microhematuria. The panel is scheduled
to be convened on 19 February 2026 at 6pm (ET). Its formation demonstrates that
Novitas recognizes the importance of the AUA’s update to the 2025 Microhematuria
Guideline and understands the strength of the evidence supporting Cxbladder.
• Our change to the name of our next generation test Monitor Plus to Surveillance Plus
to better reflect its intended use as a tool for the surveillance for bladder cancer
recurrence.

Total laboratory throughput (TLT) in Q2 26 fell 9.0% to 6,286 tests from the 6,905 tests in Q1
26. US TLT was down 13.1% to 4,971 from 5,722 in Q1 26. APAC volumes were up 11.2% to
1,315 from 1,183 tests in Q1 26, largely reflecting an increase in clinical study volumes.
In the US Pacific Edge accelerated the decision to discontinue Detect following the inclusion
of Triage in the new American Urological Association (AUA) Microhematuria Guideline in
February 2025 and the Medicare non-coverage determination. We have successfully
concluded that migration, with Triage and Triage Plus now accounting for 82% of tests
processed at our US laboratory, up from 22% in Q4 25, the last quarter before the non-
coverage determination.
Reflecting a reduction in our sales force we have seen an improvement in our sales force
efficiency metric (tests per sales FTE) to 403 from 381 tests per sales FTE in Q1 26. The sales
force reduction, and the loss of Medicare coverage has also impacted the number of ordering
clinicians (803 ordering clinicians in Q2 26, down from the 907 in Q1 26). Tests per unique
ordering clinician were steady at 6.2 in Q2 26 compared to 6.3 in Q1 26.

1
Savage et al., Accepted October 6, 2025. Diagnostic Performance of Cxbladder® Triage Plus for the
Identification and Stratification of Patients at Risk for Urothelial Carcinoma: The Multicenter, Prospective,
Observational DRIVE Study.

2

The fall in the number of ordering clinicians reflects the challenges associated with selling
noncovered products, including the additional administrative processes imposed on clinicians
and general market confusion caused by migrating customers from a well-known test to an
unfamiliar one and the subtle differences in patient population for different Cxbladder tests.
The additional burdens include the requirement to provide patients with an advanced
beneficiary notice (ABN) informing them they may be held financially responsible for the test if
Medicare denies payment. ABNs insulate Pacific Edge from test non-payment.
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.

---

OCTOBER 2025
INVESTOR UPDATE
INSIDE
Letter from the CEO 2
Q2 26 test volumes 3
Novitas to convene expert panel 5
Triage Plus commercialization
progress 7
DRIVE Study published 8
Clinical evidence program 9
US leadership change 10

Dear Shareholders,
Pacific Edge has closed out 1H 26 confident that
we have definitively shifted the conversation on
Medicare reimbursement for Cxbladder. We have
also further positioned the company for a faster
path to profitability once the value of our tests is
fully recognized through positive coverage policy in
an LCD by Medicare.
The company has achieved three significant
milestones demonstrating this progress.
Firstly, Novitas, our Medicare Administrative
Contractor has announced its intention to
convene a panel of experts called a
Contractor Advisory Committee
(CAC) to “to discuss evidence for
the use of urine-based biomarkers
in patients with microhematuria.”
The CAC is tentatively scheduled
for February 19, 2026 at 6pm ET
and demonstrates that Novitas
recognizes the importance of
the AUA’s update to the 2025
Microhematuria Guideline and
understands the strength of the
evidence supporting our tests (see
page 5).
Secondly, the US Centers for Medicare
& Medicaid Services (CMS) recommended
a reimbursement rate of US$1,328 for Cxbladder
Triage Plus — a price that is US$568 or 75% above
the US$760 price of our existing tests (Triage, Detect
and Monitor) — materially enhancing our US growth
prospects once we have achieved Medicare coverage
for Triage Plus (see page 7).
Additionally, just after the quarter closed, our
DRIVE Study, which demonstrates the clinical validity
of Cxbladder Triage Plus in a veterans’ population, was
accepted for publication in the Journal of Urologic
Oncology
1
. This publication provides the clinical
validation evidence necessary for us to formally
request Novitas to also consider coverage for Triage
Plus (see page 8).
Novitas’ indication that it will convene the CAC
next year does impact the Medicare coverage
timeline we signaled at our annual meeting in August.
However, the rigor in this process demonstrates
an increased understanding of the strength of
our evidence and the value of our tests, given the
inclusion of Cxbladder Triage in the AUA Guideline.
This delay is a source of immense frustration
for the company, but we expect to navigate it.
Having not reviewed new evidence for our tests
since September 2023, our Medicare coverage
status has simply not kept pace with the cadence of
evidence nor the weight of clinical opinion, including
the endorsement of the AUA, the world’s premier
urological professional society.
The consequences of this continue to
drag on the operational performance of
Pacific Edge, as the volumes we report
today signal (see page 3). Novitas’
actions during the establishment
and finalization of the LCD — and
the consequent administrative
burden this imposes on clinicians,
patients and the healthcare
payers — represents a significant
operating barrier to delivering the
best patient care.
Overcoming this hurdle isn’t a
question of if, but when — and we
are pursuing every avenue to deliver
the value established through our clinical
studies. The most productive route outside the
formal reconsideration process is ongoing dialogue
with the Coverage and Analysis Group at CMS and
the Medicare appeals process (see page 6).
Since the non-coverage determination took effect
in April, we have continued to seek reimbursement
for Cxbladder Triage on the grounds that Guideline
recommended tests are medically reasonable and
necessary and therefore eligible for reimbursement
under the US Social Security Act.
While initial claims for Triage tests have been
denied as expected, we have filed appeals for a
substantial portion of these claims and expect to
have them heard by an Administrative Law Judge
(ALJ). Given the strength of the new evidence from
2024 (STRATA) and 2025 (AUA Microhematuria
Guideline) that was not considered during the
establishment of the LCD, Pacific Edge sees a high
probability of success on appeal.
LETTER FROM THE CEO
Medicare reimbursement
conversation shifting in
our favor
“... timeframes
of the appeals
process are protracted,
and we do not expect
these efforts to begin
contributing to revenue
until the second half of
this financial year.”
2
1
Savage et al., Accepted October 6, 2025. Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification of Patients
at Risk for Urothelial Carcinoma: The Multicenter, Prospective, Observational DRIVE Study.

However, statutory timeframes of the appeals
process are protracted, and we do not expect these
efforts to begin contributing to revenue until the
second half of this financial year.
Outside the US, demand remains encouraging.
We have meanwhile strengthened our balance
sheet with the completion during the quarter of
a capital raise that secured $20.7
1
million in new
equity. These funds give us the ability to navigate
the US reimbursement environment, maintain our
commercial footprint and continue to advance
our clinical evidence program that — as the past
year has demonstrated beyond doubt — is at the
foundation of our shareholder value creation.
Looking ahead, operating discipline remains
a priority, with close attention to sales force
productivity and cost control to ensure careful
capital management.
We thank shareholders for their continued
support as we navigate this critical period, and
we look forward to updating you further on our
progress when we report our 1H 26 financial results
in late November.
With my warm regards,
Dr Peter Meintjes
Chief Executive
LETTER FROM THE CEO CONTINUED
Cxbladder tests processed through Pacific Edge’s laboratories in the three months to the end of
September 2025 (Q2 26) have weakened amid the disruption caused by transitioning US customers from
Detect to Triage and the extra administrative processes faced by healthcare payers and clinicians since
the loss of Medicare coverage in April 2025.
Total laboratory throughput (TLT) in Q2 26 fell 9.0% to 6,286 tests from the 6,905 tests in Q1 26. US
TLT was down 13.1% to 4,971 from 5,722 in Q1 26. APAC volumes were up 11.2% to 1,315 from 1,183 tests in
Q1 26, largely reflecting an increase in clinical study volumes.
In the US Pacific Edge accelerated the decision to discontinue Detect following the inclusion of Triage
in the new American Urological Association (AUA) Microhematuria Guideline in February 2025 and the
Medicare non-coverage determination. We have successfully concluded that migration, with Triage and
Triage Plus now accounting for 82% of tests processed at our US laboratory, up from 22% in Q4 25, the
last quarter before the non-coverage determination.
Reflecting a reduction in our sales force we have seen an improvement in our sales force efficiency
metric (tests per sales FTE) to 403 from 381 tests per sales FTE in Q1 26. The sales force reduction, and
the loss of Medicare coverage has also impacted the number of ordering clinicians (803 ordering clinicians
in Q2 26, down from the 907 in Q1 26). Tests per unique ordering clinician were steady at 6.2 in Q2 26
compared to 6.3 in Q1 26.
The fall in the number of ordering clinicians reflects the challenges associated with selling non-
covered products, including the additional administrative processes imposed on clinicians and general
market confusion caused by migrating customers from a well-known test to an unfamiliar one and the
subtle differences in patient population for different Cxbladder tests.
1
The additional burdens include the
requirement to provide patients with an advanced beneficiary notice (ABN) informing them they may be
held financially responsible for the test if Medicare denies payment. ABNs insulate Pacific Edge from test
non-payment.
TEST VOLUMES
Administrative burdens weigh on US test volumes
3
1
With the discontinuation of Cxbladder Detect in the US, Pacific Edge no longer provides a test to justify an intensification of a urological work up
or resolve diagnostic dilemmas. The tests that remain commercially available in the US are Cxbladder Triage (a test to rule out the presence of
urothelial cancer) and Cxbladder Monitor (a test used in the surveillance for urothelial cancer recurrence).

-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
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
5,722
1,183
6,905
Q2 26
4,971
1,315
6,286
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)
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
6.4
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)
226
201
239
288
265
30
3333
30
28
21
15151515
907
292
5.9
6.7
6.8
403
379
6.4
6.7
379
6.3
6.2
Q4 25Q1 26
803
Q2 26

Q2 23Q3 23Q4 23Q1 24Q2 24
Q3 24Q4 24Q1 25Q2 25Q3 25Q4 25
Q1 26
12
Q2 26
1616
381
381
406
7.1
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 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
5,722
1,183
6,905
Q2 26
4,971
1,315
6,286
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)
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
6.4
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)
226
201
239
288
265
30
3333
30
28
21
15151515
907
292
5.9
6.7
6.8
403
379
6.4
6.7
379
6.3
6.2
Q4 25Q1 26
803
Q2 26

Q2 23Q3 23Q4 23Q1 24Q2 24
Q3 24Q4 24Q1 25Q2 25Q3 25Q4 25
Q1 26
12
Q2 26
1616
381
381
406
7.1
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 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
5,722
1,183
6,905
Q2 26
4,971
1,315
6,286
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)
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
6.4
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)
226
201
239
288
265
30
3333
30
28
21
15151515
907
292
5.9
6.7
6.8
403
379
6.4
6.7
379
6.3
6.2
Q4 25Q1 26
803
Q2 26

Q2 23Q3 23Q4 23Q1 24Q2 24
Q3 24Q4 24Q1 25Q2 25Q3 25Q4 25
Q1 26
12
Q2 26
1616
381
381
406
7.1
403
7,816
FIGURE 1: TOTAL TEST VOLUMES
FIGURE 2: CXBLADDER CLINICAL ADOPTION
FIGURE 3: US SALES FORCE EFFICIENCY
TEST VOLUMES CONTINUED
Pacific Edge is renaming its next generation surveillance product
Cxbladder Monitor Plus to Cxbladder Surveillance Plus to better
reflect the test’s intended clinical use.
In clinical and regulatory contexts, the word ‘surveillance’ is understood as referring to patients who
are expected to be disease-free but remain at risk of new or recurrent tumors. Conversely, the word
‘monitor’ is used in the context of patients that are suspected to have residual disease.
Our market research was conclusive that Surveillance Plus fosters a clearer understanding of the
intended use of the test for physicians, patients and payers. Long term, we believe this will create
greater brand equity, thereby supporting broader adoption of the test.
Surveillance product name change
4
*The US total of Q1 26 has been amended from the 5,717 previously reported.
*

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. J Urol 2024.
2
Harvey et al (2025) Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma.
Diagnostics. 2024; 14(18):2061.
Novitas moves closer to recognizing
hematuria evaluation as a Medicare benefit
Medicare Administrative Contractor (MAC) Novitas has moved a step closer to re-opening the
LCD which governs coverage for Cxbladder tests. It has announced its intention to convene an expert panel “to
discuss evidence for the use of urine-based biomarkers in patients with microhematuria.”
Novitas has tentatively scheduled the meeting for 19 February 2026 at 6.00pm (US Eastern Time).
In a notice sent to interested parties Novitas said: “We are in the process of gathering the most current literature,
as well as developing questions relative to the available evidence, to stimulate discussion during the meeting.”
We are pleased with the initiative which appears to show that Novitas has acknowledged the importance
of the AUA Microhematuria Guideline and is taking a robust and credible approach to policy development.
The panel, known as a Contractor Advisory Committee (CAC) is open to virtual attendance by the public and
transcripts will be published to their website in audio and text format after the event. It will be comprised of
urology subject matter experts and will be tasked with considering how to bring Medicare policy into alignment
with the new Guideline.
Under the Medicare Program Integrity Manual, CAC meetings are initiated by the MAC and generally precede
the draft issuance of a new or substantially revised Local Coverage Determination (LCD). The meetings are
advisory in nature to ensure all relevant evidence is appropriately considered.
We expect the panel to consider the Guideline; the STRATA
1
Study that was ignored by Novitas’ January 2025
non-coverage determination yet precipitated the Guideline revision; and all new clinical evidence published prior
to the CAC meeting. This evidence includes the analytical validation study published in July
2
and the DRIVE Study
recently-accepted for publication that demonstrates the clinical validity of Triage Plus (which Pacific Edge will
also use to request Medicare coverage from Novitas) (see page 8).
While the timing of any decision on coverage remains uncertain, MACs generally give an indication of their
intentions in relation to coverage shortly after the conclusion of the CAC. In the event of a draft LCD being
proposed, the MAC is required to finalize or withdraw the LCD 365 days after issue.
5
MEDICARE COVERAGE
“the initiative...
shows that Novitas
has acknowledged
the importance of the
AUA Microhematuria
Guideline.”

1
https://www.medicare.gov/providers-services/claims-appeals-complaints/appeals/original-medicare
2
ECRI is the Emergency Care Research Institute https://home.ecri.org/
FY26 revenue linked to appeals process success
Since the non-coverage determination for Cxbladder became effective in April, Pacific Edge has filed
appeals on all Medicare claims for Cxbladder Triage that have been denied reimbursement, and it is actively
advancing them through the multi-stage Medicare administrative appeals process
1
.
Our success through this process — and particularly our success at the Office of Medicare Hearings and
Appeals (OMHA) before an Administrative Law Judge (ALJ) — will be determinative for FY 26 US revenue.
However, the process is by its nature slow, meaning any successful appeals filed since April are more likely to
contribute to revenue in the second half of the financial year.
At the first and second levels of Medicare appeals, denials are largely automated and based rigidly on
policy. However, at the third level of appeals, Administrative Law Judges are expected to show deference
to LCDs, but are not bound by them; and can consider other evidence, including the updated AUA 2025
Guidelines, and new evidence like the May 2024 STRATA Study, the analytical validation studies, and the
2025 ECRI
2
report that gave Triage a positive 4/5 rating. Based on this stronger, most-current clinical
evidence, we are significantly more confident of success at the ALJ stage. Beyond the ALJ, additional
avenues remain — the Medicare Appeals Council and ultimately judicial review — but the ALJ outcome will
be the most critical inflection point for revenue recovery.
MEDICARE APPEALS PROCESS
6
MEDICARE COVERAGE CONTINUED
FURTHER REVIEW
Medicare Appeals Council
Federal District Court
REDETERMINATION
Medicare Administrative
Contractor (MAC)
Who: Novitas
Timeline: ~60 days to
respond to each appeal
RECONSIDERATION
Qualified Independent
Contractor (QIC)
Who: C2C Innovative
Solutions
Timeline: ~60 days to respond
at which point the request
can be escalated to OMHA
HEARING
Office of Medicare Hearings &
Appeals (OMHA)
Who: Administrative Law
Judge (ALJ)
Timeline: Target 90 days,
but often longer

CMS price and DRIVE Study advance Triage Plus
Pacific Edge has received two major boosts to the commercialization
of Cxbladder Triage Plus, our next generation test for hematuria
evaluation. First, CMS has recommended a significant uplift in the
test’s price, positioning the company for a step change in commercial
outcomes once coverage is achieved. Second, our DRIVE Study has
been published in the Journal of Urologic Oncology
1
confirming the
test’s clinical validity and supporting the case for Medicare coverage
and Guideline inclusion.
7
TRIAGE PLUS COMMERCIALIZATION
CMS pricing decision
positions Triage Plus for
faster path to profitability
The US Centers for Medicare & Medicaid
Services (CMS) recommendation of US$1,328.32
for Cxbladder Triage Plus stands to provide a
significant boost to Pacific Edge’s US growth
prospects.
The new price compares favorably with
the current US$760 CMS price for Triage and
represents a material uplift from the draft price of
US$1,018.44 first proposed through the ‘Gapfill’
process in April.
The CMS final price for Triage Plus is still subject to 60 days of notice and comment, but is
typically not expected to change and is expected to become effective from 1 January 2026. Once
coverage is secured, this higher reimbursement rate will substantially improve the economics of
Pacific Edge’s US commercial model. The new price meaningfully increases the potential revenue
per test and enhances the return on investment from the sales force, facilitating more rapid scaling
of the business in the US market.
Triage Plus is central to Pacific Edge’s US growth strategy: hematuria evaluation tests represent
around 82% of total US laboratory throughput, and the company will prioritize migrating
from Triage to Triage Plus once a local coverage determination has been made. The higher
price provides the commercial headroom to expand the reach of the sales team and lift their
productivity. Pacific Edge’s commercial team will focus on three levers to capture this opportunity:
• Increasing the number of physicians ordering Triage Plus by expanding education
and awareness.
• Growing test penetration per physician by embedding the test more deeply
into clinical workflows.
• Lifting productivity per Account Executive by improving the number of tests
delivered per territory.
1
Savage et al., Accepted October 6, 2025. Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification
of Patients at Risk for Urothelial Carcinoma: The Multicenter, Prospective, Observational DRIVE Study.

8
TRIAGE PLUS COMMERCIALIZATION CONTINUED
Reconsideration request to follow DRIVE publication
Our DRIVE Study — which demonstrates the clinical validity of
Cxbladder Triage Plus in a veterans’ population — has been published
in the Journal of Urologic Oncology
1
clearing the way for Pacific Edge
to ask Novitas to consider coverage of the test.
The DRIVE Study — The Diagnostic Performance of Cxbladder Triage
Plus for the Identification and Priority Evaluation of Veterans at Risk for
Urothelial Carcinoma — evaluated the performance of Cxbladder Triage
Plus when compared to cystoscopy combined with histopathologic
confirmation of urothelial cancer. It confirmed the performance
characteristics of Triage Plus established in the Analytical Validation
publication (Harvey et al. 2025)
2
in a patient population independent of
the development dataset in the proof-of-concept study by Lotan et al.
in 2023
3
.
The authors of the study concluded: “Cxbladder Triage Plus demonstrated clinical validity
in this veterans population with gross hematuria or microhematuria, with high sensitivity and
specificity. These findings indicate that Triage Plus may be safely used to
rule out or detect [urothelial cancer] in patients with hematuria.”
Based on this evidence, we will request coverage of Triage
Plus and will seek to ensure the study is considered during the
Contractor Advisory Committee deliberations planned for the
new year (see page 5). We also believe the study provides
grounds for the AUA to consider an amendment to the
Microhematuria Guideline to list Triage Plus alongside Triage.
We are engaging with the AUA to determine the process for
amending the Guideline to include Triage Plus.
Te s tSensitivitySpecificityNegative
Predictive
Value
Positive
Predictive
Value
Test
Negative
Rate
Cxbladder Triage93%38%98.5%11%35%
Cxbladder Triage Plus
Intermediate risk patients
94%77%99.3%26%71%
Cxbladder Triage Plus
High risk patients
95%51%90%
1
Savage et al., Accepted October 6, 2025. Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification of Patients
at Risk for Urothelial Carcinoma: The Multicenter, Prospective, Observational DRIVE Study.
2
Harvey et al., submitted. Analytical Validation of Cxbladder® Triage Plus Assay for risk stratification of hematuria patients for urothelial carcinoma
Diagnostics 2025, 15, 1739.
3
Lotan et al., (2023). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk
Stratification. The Journal of Urology, 10-1097.
“Cxbladder Triage
Plus demonstrated
clinical validity in this
Veterans population
with gross hematuria
or microhematuria...”

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 Triage
• CV/CU Triage Plus
(retrospective)
• 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 Oct 2025 and Clinical Study
Report (CSR) expected Oct 2025
DRIVE
Detection and Risk
stratification In
VEterans presenting
with hematuria
• CV Triage Plus
• Data MH pooled
analysis
• MH and GH
• Risk stratification
• Enrolment closed with 710 patients including 48
tumour confirmed patients from 10 US VA sites
• Database lock completed and published October
2025
microDRIVE
Detection and
Risk stratification
In VEterans
presenting with
microhematuria
• CV Triage Plus
• Data MH pooled
analysis
• MH
• Risk stratification
• Currently 421 samples received to date with 11 UC
cases confirmed 35 targeted
• Study expanded with 3 sites and all currently
enrolling
• Study design will be changed to include high risk
patients presenting with GH
• The target is 1000 patients with LPI projected Q2-4
2026
AUSSIE
Australian Urologic
risk Stratification
of patientS wIth
hEmaturia
• CV Triage Plus
• Data MH or GH for
pooled analysis
• MH and GH
• Risk stratification
• The target is 35 UC confirmed patients including
a minimum of 10 MH UC confirmed
• There are 758 subjects enrolled including 53 UC
confirmed (GH+MH) including 10 MH UC patients
• Enrolment is closed, database lock is projected as Q4
2025 and publication submission Q1-2 2026
POOLED ANALYSIS• CV Triage Plus
from pooled
analysis
• MH and GH
• Risk stratification
• MH (separately GH) patient data from DRIVE, AUSSIE
& microDRIVE will be pooled and analysed
• MH pooled analysis is delayed pending microDRIVE
completion and is expected late 2026
• GH pooled analysis paper submission is expected in
late 2026
CREDIBLE
Cystoscopic
REDuction
In BLadder
Evaluations for
microhematuria
• CU Triage Plus • MH
• Risk stratification
• All sites have completed contracts and IRB
approvals
• Twelve sites actively enrolling patients (currently
82 enrolled, target is 1000)
LOBSTER
LOngitudinal
Bladder cancer
Study for
Tumor Recurrence
• CV Monitor and
Surveillance Plus
• Surveillance
• Risk stratification
• Enrolment will be complete when 75 UC recurrences
are observed and last patient expected Q3-2025
• Currently 428 subjects enrolled with 1142 samples
including 74 confirmed UC recurrences
• Protocol amendment provides for continued
scheduled surveillance visits & urine collections into
2026
OCTOPUS
Ongoing Cxbladder
Testing for
Optimized Patient
Experience
in Urothelial
Surveillance
• CU Cxbladder
Surveillance
• Surveillance
• Risk stratification
• Currently at the planning stage with an Advisory
Board scheduled for Dec-2025 to refine the study
design
9
Microhematuria, MH / Gross hematuria, GH
Cxbladder Triage Plus (Triage Plus) / Cxbladder Monitor Plus, now called Cxbladder Surveillance
Quarterly dates are calendar year not financial years

Opening the next chapter
After nearly 10 years of service to the company Pacific Edge Diagnostics USA President David Levison is now
stepping away from the business.
In addition, to the three years in the current role, David served five years as an Independent Director and was
seconded to lead PEDUSA as Executive Chairman in 2020. During his management of the PEDUSA team, test
volumes increased 1.6 times, and revenue grew 2.9 times.
David has maintained the primary relationship with the key opinion leaders at our key account Kaiser
Permanente and helped to establish Cxbladder as a cornerstone of healthcare delivery in the Southern California
Permanente Medical Group.
When you look back on your time at the company what are you
most proud of?
Since I joined the Board of Directors in 2016, we have made
progress in many areas. The acceleration of both the quality
and quantity of our clinical data is very gratifying as it was a
key objective that I discussed with the Board when I assumed
responsibility of the US business.
The other areas where we have made progress - with more work
still to be done - include the expansion of Cxbladder’s brand
recognition, the improvement of our internal data systems and
analytical tools as well as a sharper sales and marketing focus on
selling the clinical value of Cxbladder products.
What has been your biggest disappointment?
From an external standpoint, the inconsistent reimbursement
of our products given their strong published data is a large
disappointment.
What are you going to miss about the company (what have you
most enjoyed in your time with the company)?
I will miss working with a dedicated group of people who
have shown resilience and dedication amid the reimbursement
uncertainty we have faced over the last three years.
Do you have any parting advice for the team and investors?
Success for Pacific Edge is a marathon so don’t get too worried
about the setbacks or too excited by the wins. If you keep the
patients’ interests as our top priority, success will follow.
What’s next for you?
I am investigating a number of opportunities, both inside and
outside of the molecular diagnostic space. The new technologies
being deployed in the diagnostic industry are expanding the
range of clinical value propositions that can be delivered so it is an
exciting time to be in this arena.
Pacific Edge wishes David well. He will not be replaced, instead
Pacific Edge has commenced a search for a Chief Commercial
Officer (CCO) that will assume responsibilities for the Sales,
Marketing and Market Access functions with a focus on the US.
US LEADERSHIP
DAVID LEVISON
• Pacific Edge Diagnostics USA
– President Americas
Former roles:
• Pacific Edge Diagnostics USA
- Executive Chairman
• Pacific Edge
- Non-Executive Director
• Qlarity Imaging
- Chief Executive Officer
• CardioDx
- Director, Chief Executive Officer
and Chief Strategic Officer
• CareDx
- Board member
• Texas Pacific Ventures
- Venture Partner
• iScribe
- Founder, President, and Director
Education:
• B.A. (Williams)
• MBA (Stanford)
10

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