PACIFIC EDGE ADVANCES US COMMERCIAL RECOVERY

19 October 2026
PACIFIC EDGE ADVANCES US COMMERCIAL RECOVERY
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX/ASX: PEB) today
reports increased momentum towards its US commercial recovery.
The company’s Q2 27 Investor Update, released today, also provides updates on:

Proposed Medicare price increases of approximately 35% for Cxbladder Monitor
and 39% for Cxbladder Triage, lifting the 2027 prices from the current US$760 to
US$1,026 and US$1,058 respectively, subject to CMS finalization on 1 January 2027

Cxbladder gained in-network coverage at Blue Cross plans in North and South
Carolina from 1 November 2026. Pacific Edge has established policy and in-network
contracting with these plans, which cover nearly 8 million lives

Triage Plus received funding allocation within the Veteran’s Administration,
Pacific Edge’s first facility-level Blanket Purchase Agreement within the US Veterans
Administration system

US commercial volumes declined 13.0% to 2,867 tests as Pacific Edge maintained
lower commercial spending and repositioned towards reimbursable intermediate risk
microhematuria patients, partly offset by a 3.7% increase in APAC commercial volumes
to 1,201 tests

Triage Plus continued to gain traction, representing 5.6% of US tests in Q2 27 and
10.8% of tests in September 2026, up from 0.8% in Q1 27. Enrolment target of ~2000
patients achieved for the Triage Plus concordance study at KP SoCal

Two new peer-reviewed clinical studies published strengthening the evidence
base, with the Canterbury New Zealand study demonstrating faster access to specialist
assessment and treatment, fewer avoidable referrals and improved equity for Māori,
and the AUSSIE study validating Triage Plus in an Australian population

Pacific Edge Chief Executive Dr Peter Meintjes said: “The proposed pricing increases for
Triage and Monitor, in-network contracting with Blue Cross plans and continued progress with
Triage Plus are encouraging signs that the building blocks for US commercial recovery are
falling into place. Final Medicare coverage remains the critical near-term milestone. We
continue to expect the policy to be finalized by the end of this calendar year. In the meantime,
US volumes continue to reflect our disciplined approach to spending and the transition towards
reimbursable patients.”
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: +64 22 032 1263

2

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 hematuria 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
twenty-five 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 2026
INVESTOR UPDATE
INSIDE
Letter from the CEO 2
Q2 27 test volumes 4
PAMA adjustments for 2027 6
BCBS payer contract finalized 6
NZ Hematuria study published 7
AUSSIE study published 8
Willy Iglesias, CDO 8
Clinical evidence 9

Dear Shareholders,
Pacific Edge starts the second half of FY27 with
momentum and clarity. The US reimbursement
environment remains demanding, but with draft
coverage for Triage and Triage Plus proposed, the
building blocks of recovery are now in place.
In the last quarter, we gained in-network status by
contracting with the Blue Cross Blue Shield plans in
North and South Carolina, which cover 8 million lives.
Two new peer-reviewed publications have extended
our evidence portfolio, and we have made selective
investments in a sharper, more disciplined US
commercialization strategy.
Our most important near-term
milestone remains the finalization
of the Novitas LCD confirming
Medicare coverage of Cxbladder.
While Novitas controls the timing,
we continue to expect a final
policy before the end of calendar
2026, and our focus now is on
the billing, documentation and
commercial processes that will
let us convert that coverage into
reimbursed volume from the day it
becomes effective.
With the draft LCD explicitly
distinguishing microhematuria patients from
cancer patients in the non-coverage LCD, we are
working with Novitas on case-by-case payments for
eligible Cxbladder tests delivered to Medicare patients
ahead of finalizing the LCD.
Among commercial payers the Blue Cross Blue
Shield plans in North and South Carolina have
adopted a positive medical policy for Cxbladder
Triage (see page 6). They will reimburse the test
as an in-network service at contracted rates from
1 November 2026, giving their nearly 8 million
members access to the test under their existing health
insurance plans.
In our last quarterly update, we highlighted
the importance of targeting intermediate risk
microhematuria patients, who are generally
younger, have commercial payer insurance and are
predominantly women. These patients are frequently
triaged by Advanced Practice Providers
1
within the
urology office, or seen by gynecologists. This creates
a targeted opportunity for Pacific Edge. Unlike
urologists, APPs and gynecologists do not perform
cystoscopy and have a strong incentive to manage
patients within their own practice where clinically
appropriate, reducing unnecessary referrals to the
general urologist.
This opportunity is particularly relevant for the
clinical outcomes for women, where hematuria
is more likely to be attributed to conditions
such as urinary tract infection, potentially
delaying evaluation for bladder cancer.
This diagnostic disparity is known to
contribute to poorer outcomes for
women, including a lower five-year
survival rate than men (50% versus
60%), and represents an important
unmet need that Triage Plus is well
positioned to address through
non-invasive risk stratification.
We have focused on identifying
these patients and clinicians across
integrated delivery and private practice
networks, and on proving the model in
priority territories before committing capital
to broader expansion.
The Southern California Permanente Medical
Group (KP SoCal) remains the clearest demonstration
of what happens when Cxbladder is integrated in
a clinical pathway rather than being sold test by
test. During the quarter we completed enrolment of
the ~2000 patients in our Triage Plus concordance
study with KP SoCal to demonstrate the superior
performance of Triage Plus on patients currently
receiving Triage in routine clinical practice. KP SoCal’s
transition to Triage Plus will take some time, but the
new test improves both the clinical offering and the
economics of every test we run in that system. We
expect the data to be analyzed in due course and to
form the basis of another peer-reviewed publication
bolstering the evidence supporting Triage Plus.
“We now
have a clear policy
pathway, two new
publications, a
sharper commercial
model and the
digital leadership
to scale it.”
2
1
APPs include nurse practitioners and physician assistants/associates
LETTER FROM THE CEO
Advancing our US
commercialization strategy

During the quarter we secured our first facility-
level Blanket Purchase Agreement (BPA) within the
Veterans Administration (VA) system, a five-year BPA
allocating ~US$1.3m for Cxbladder testing with the
Marion, Illinois VA for Triage Plus and Monitor. BPAs
are not required for VA facilities to order Cxbladder,
but they remove one of the principal administrative
roadblocks regarding funding for new tests raised
by the pathology laboratories within the VA. This
is an important practical step that reduces the
operating friction associated with ordering our tests.
Furthermore, given the predominantly high-risk VA
patient population, this BPA demonstrates demand
and a pathway to payment for Triage Plus in high-risk
microhematuria patients, while generating additional
real-world clinical evidence in this population to
complement the core evidence established through
the DRIVE
2
Study.
Also, during the quarter CMS
3
published its
proposed re-pricing of tests in the CLFS
4
after the
2026 PAMA
5
reporting cycle. If finalized as proposed,
Cxbladder Monitor and Cxbladder Triage would
increase in price to $1,026 and $1,058 respectively
from 1 January 2027, a meaningful increase from the
current Medicare pricing of $760. The rates remain
preliminary and subject to CMS finalization, but they
are directionally positive for revenue, margin and the
benchmark we use in commercial payer discussions.
We have provided an explanation of PAMA reporting
and more information on this pricing result later in this
update (see page 6).
We are also doing more to showcase Pacific Edge’s
future to our long-standing investors and prospective
investors with a greater presence at relevant investor
conferences. Our corporate presentation has been
updated, including information on our operating
assumptions on test volumes, average revenue per
test and gross margin to achieve breakeven. Our aim
is to allow shareholders to track progress against the
longer-term milestones we are working towards.
Evidence remains the foundation of future
commercial success. Two peer-reviewed publications
during the quarter – a retrospective audit of the
hematuria pathway in Canterbury from 2013-2021
6

and the AUSSIE
7
study (see pages 7 and 8) – further
strengthened our evidence base. Together with
STRATA
8
, DRIVE, and the upcoming microDRIVE study,
as well as the microhematuria and gross hematuria
pooled analyses, Pacific Edge will have the world’s
strongest clinical evidence in urine-based biomarkers
for hematuria evaluation, to support clinical change,
guideline adoption and reimbursement.
In internal news, we were pleased to welcome
Willy Iglesias as Chief Digital Officer during the
quarter. His mandate is commercial: to put in place the
systems, integrations and data discipline that allow
a small team to serve a very large market (see page
8). Willy’s experience across healthcare technology,
cybersecurity and digital transformation is expected
to help Pacific Edge scale more efficiently, improve
the customer experience for clinicians and health
systems, and ensure that increases in test volume
translate more effectively into revenue and margin.
We remain focused on capital discipline. We
are awaiting finalization of the draft LCD, and the
US operating environment remains hard work.
But we now have a clear policy pathway, two new
publications, a sharper commercial model and the
digital leadership to scale it. We are optimistic about
what is in front of us and realistic about the work
required to get there.
My thanks to the Pacific Edge team for their
perseverance, and to our shareholders for their
continued support through a demanding but
important period for the company. We look forward
to updating you as the final LCD process advances
and as our commercial, reimbursement and clinical
evidence milestones are delivered.
With my warm regards,
Dr Peter Meintjes
Chief Executive
LETTER FROM THE CEO CONTINUED
3
2
Savage et al (2025) 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
3
Center for Medicare and Medicaid Services
4
Clinical Lab Fee Schedule
5
Protecting Access to Medicare Act
6
Eaton, D., Kerdemelidis, M., Losco, G., Mark, S., Patu, M., Elliot, N., & Frampton, C. (2026). Cxbladder triage in haematuria assessment reduces time
from referral to specialist assessment and bladder cancer treatment and improves equity for Māori. ANZ Journal of Surgery.
7
Buhariwalla V, Sethi K, Vela I, Hayne D, Atchia Z, de Lange M, Lough T, White A, Ranasinghe W. Validation of Cxbladder Triage Plus in Australian Patients
with Haematuria: The AUSSIE Study. Accepted for publication in the BJU International; 2026.
8
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.

4
Commercial test volumes in Q2 27 reflected our continued execution of a strategic shift toward
intermediate-risk patients in line with the draft Medicare policy and the shift to our next generation
test for hematuria evaluation, Cxbladder Triage Plus.
We have deliberately reduced commercial spend while awaiting Novitas to finalize Medicare
coverage for Triage and Triage Plus. Rather than backfilling all territories, we continue to concentrate
resources on our most productive accounts, initiate strategic selling to integrated delivery networks
and focus on female-specific call points. While this discipline constrains near-term volume, it is
sharpening our understanding of the accounts and patient populations that can support long-term
profitable growth, positioning us to deploy commercial investment more effectively when coverage
is finalized.
US commercial volumes were 2,867 tests compared with 3,296 in Q1 27 with the 13.0% fall
partially offset by a 3.7% increase in Asia Pacific commercial volumes to 1,201 tests from 1,158 in
Q1 27. The US reduction also reflects payers waiting for a positive Medicare signal and the steps
implemented to transition clinicians to order for intermediate risk microhaematuria patients.
Total laboratory throughput (TLT) was 5,258 for Q2 27, up 2.7% from 5,120 in Q1 27 as increased
clinical study samples were processed in Q2 27.
We are seeing an uptick in volumes of Triage Plus, a higher margin test that is moving to improve
the unit economics of our front-line sales team and accelerate our journey towards profitability.
In the US, Triage Plus represented 5.6% of total tests in Q2 27, up from 0.8% in Q1 27. Triage Plus
represented 11% of US tests in September. In APAC Triage Plus represented 8.1% of total tests up from
7.6% in Q1 27.
Our sales force efficiency metric of commercial tests per sales FTE was 573, compared with 659
in Q1 27, reflecting the lower commercial volumes as we maintain a more focused sales footprint.
The number of unique ordering clinicians was 704, against 814 in Q1 27, while tests per ordering
clinician increased slightly to 4.1 from 4.0, indicating stable utilization among active customers. As
we rebuild around intermediate-risk microhematuria patients, we are tracking payer mix, medical
necessity documentation, and claims success alongside these volume measures, because together
they determine whether a test ordered becomes a test paid.
Kaiser Permanente remains our largest single contributor to US volume and our best evidence
that adoption accelerates when Cxbladder is embedded in a clinical pathway. Enrolment of the
Triage Plus comparison study completed with
~2000 patients and progresses to the data
analysis phase on a path to future publication.
When published, this provides the basis for a
transition from Triage to Triage Plus a move
that would expand the patient indication,
improve clinical performance, save Kaiser
Permanente more money and drive more
revenue to Pacific Edge.
In APAC we are continuing to see the region’s
progress towards profitability on a direct-cost
basis. Improved pricing and the continuing shift
in mix towards Triage Plus and intermediate risk
female patients are lifting revenue per test, while
our engagement with public health systems,
hospitals and distribution partners across
New Zealand, Australia and Asia continues to
widen access.
TEST VOLUMES
Volumes reflect strategic shift to intermediate risk patients

5
TEST VOLUMES CONTINUED
US SALES FORCE EFFICIENCY
-
5.0
10.0
15.0
20.0
700
500
300
100
AVERAGE SAES FTE
US COMMERCIAL TEST
VOLUMES / SALES FTE
Q2 26Q3 26Q4 26Q1 27Q2 27
307
440
659
573
12.3
12.0
251
7.7
5.05.0
APAC COMMERCIAL PRODUCT MIXUS COMMERCIAL PRODUCT MIX
0%0%
10%10%
20%20%
30%30%
40%40%
50%50%
60%60%
70%70%
80%80%
90%90%
100%100%
PRODUCT MIX (%)
■

Triage
■
Detect
■
Triage Plus
■
Monitor
Q2 27Q2 27
13%
8%
42%
38%
10%
8%
39%
43%
Q1 27Q1 27
12%
1%
46%
41%
Q4 26Q4 26
11%
2%
43%
44%
Q3 26Q3 26
0%
12%
43%
45%
Q2 26Q2 26
85%
1%
14%
85%
2%
13%
86%
1%
13%
82%
6%
13%
87%
1%
13%
US TOTAL THROUGHPUT
APAC TOTAL THROUGHPUT
3,786
3,010
3,375
3,296
2,867
1,187
1,083
1,015
689
543
4,973
4,025
4,064
3,839
3,950
-
1,000
2,000
3,000
4,000
5,000
6,000
Light shade: Clinical study and evaluation tests Dark Shade: Commercial tests
Q2 26Q3 26Q4 26Q1 27
Q2 26Q3 26Q4 26Q1 27
Q2 27
Q2 27
TEST VOLUME
-
200
800
600
400
1,000
1,200
1,400
1,600
TEST VOLUME
971
1,001
1,026
1,158
1,201
339
409
492
1,310
1,410
1,518
1,281
123
1,308
107
3,786
3,010
3,375
3,296
2,867
1,187
1,083
1,015
689
543
4,973
4,025
4,064
3,839
3,950
-
1,000
2,000
3,000
4,000
5,000
6,000
Light shade: Clinical study and evaluation tests Dark Shade: Commercial tests
Q2 26Q3 26Q4 26Q1 27
Q2 26Q3 26Q4 26Q1 27
Q2 27
Q2 27
TEST VOLUME
-
200
800
600
400
1,000
1,200
1,400
1,600
TEST VOLUME
971
1,001
1,026
1,158
1,201
339
409
492
1,310
1,410
1,518
1,281
123
1,308
107
4,600
3,786
3,010
3,375
3,295
1,122
1,187
1,015
689
540
5,722
4,973
4,025
4,064
3,835
-
1,000
2,000
3,000
4,000
5,000
6,000
Q1 26
Light shade: Clinical study and evaluation tests Dark Shade: Commercial tests
Q2 26Q3 26Q4 26Q1 27
Q1 26Q2 26Q3 26Q4 26Q1 27
TEST VOLUME
-
200
800
600
400
1,000
1,200
1,400
1,600
TEST VOLUME
1,014
971
1,001
1,026
1,158
154
339
409
492
123
1,168
1,310
1,410
1,518
1,281
Bar graph: US Average Sales FTE (LHS) Line graph: US Commercial Test Volume / Sales FTE (RHS)

6
PAMA ADJUSTMENTS FOR 2027
COMMERCIAL STRATEGY
These increases are expected to become final and effective on January 1, 2027, increasing revenue per test,
improving gross margins, and establishing a stronger reimbursement benchmark for commercial payer contracting.
It is further evidence of a commercial recovery being built through evidence generation for coverage, a disciplined
pricing strategy and dedication to revenue cycle management as a core discipline at Pacific Edge.
PAMA is the law that determines how Medicare adjusts pricing for most clinical laboratory tests in the US. In
simple terms, PAMA is designed to align Medicare payment with what the private market has been paying.
Rather than relying solely on administratively determined Medicare pricing, laboratories periodically report the
rates they receive from commercial payers, which CMS uses to adjust the price every three years to the volume-
weighted median of the commercial payers.
The proposed increases are particularly notable given the role PAMA typically plays to reduce reimbursement
for many laboratory tests. That both Cxbladder tests are instead proposed to receive price increases is a positive
validation of Pacific Edge’s deliberate work on a pricing strategy applied to establishing and sustaining the value of
our tests with commercial payers.
The proposed rates do not, by themselves, determine whether a test is covered; coverage and payment remain
separate decisions.
The Centers for Medicare & Medicaid Services (CMS) has released preliminary 2027 Clinical Laboratory Fee
Schedule rates under the Protecting Access to Medicare Act (PAMA) proposing increases for Cxbladder Monitor
to US$1,026 and Cxbladder Triage to US$1,058, significant increases over the current CMS price of US$760.
The Blue Cross Blue Shield plans in North and South Carolina adopted positive medical policy for Cxbladder
Triage in Q4 FY26. This quarter, these insurers have agreed contracting terms to reimburse the test as an
in-network service from 1 November 2026, giving their nearly 8 million members access under their existing
health insurance plans.
These contracts represent the first time that a commercial payer in the US has established favorable medical
policy and in-network contracting status with Pacific Edge – the first major milestone in growing the number of lives
covered by commercial payers.
Avalon Healthcare Solutions is a lab benefit manager (LBM) that performs evidence assessments and develops
medical policies on behalf of commercial payers. It established favorable policy language for Cxbladder Triage in
December 2025 that mirrored the AUA guidelines. That favorable policy has now evolved into an in-network contract.
Positive medical policy increases the percentage of favorable adjudications of our claims, while contracting
establishes the pricing and payment dynamics that determine how much Pacific Edge receives for each test. The
details of any contract will remain confidential, but contracts typically have a substantial impact on our revenue cycle
management. For example, contracts are expected to increase the percentage of tests paid without appeal, reduce
the time to payment on claims, reduce patient deductibles and increase the revenue per test to Pacific Edge.
Going forward, Pacific Edge expects positive policy with Avalon to continue to drive additional commercial payers
to adopt policy and to contract with us. It will also support our work with other LBMs to translate their assessments
into commercial payer policy and contracts and our direct engagement with commercial payers. We expect to report
progress to investors through the number of lives that are covered by policy and contracts, and to observe progress
in our financial performance through increasing ASP and ultimately provide greater certainty and predictability to
revenue generated from tests covered by commercial payers.
Medicare proposes price increases for Triage and Monitor
Avalon policy converts into Blue Cross policy and contract

A new real world experience study from the
Canterbury Health System was published in the ANZ
Journal of Surgery
1
this quarter with an emphasis
beyond the clinical utility already established by
Davidson et al (2019 and 2020)
2
.
The publication describes the key benefits of clinical
use in a real public health system, following the 2018
decision in Canterbury to replace urine cytology with
Cxbladder Triage and upper tract imaging as the
first-line primary care work-up for hematuria. The key
outcomes for patients, physicians and health systems
are clear: faster access to specialist care, faster time
to first operative treatment for bladder cancer, fewer
avoidable referrals and improved equity for Māori
patients.
Eaton and colleagues audited 4,512 hematuria
referrals to Christchurch Hospital between March 2013
and December 2021, comparing the period before and
after Cxbladder Triage was added to the Canterbury
pathway. Under that pathway, patients with a negative
Cxbladder Triage result and normal upper tract imaging
were considered at very low probability of bladder
cancer and did not require referral for specialist
assessment and cystoscopy, unless symptoms persisted
and repeat investigation was required.
The results were clinically impactful, because
median waiting time from primary care referral to
urological specialist appointment reduced by 14.8 days,
from 57.8 days to 43.0 days, and median waiting time
from referral to first operative treatment for bladder
cancer reduced by 15.0 days, from 78.0 days to 63.0
days. Lastly, monthly hematuria referrals to specialist
urology also fell from 45.7 to 38.8, a reduction of 6.9
referrals per month, or approximately 83 fewer referrals
per year, driving economic savings for hospitals.
The study also supports the health equity case
for pathway-based use of Cxbladder. Māori patients
experienced a greater reduction in waiting time to first
operative treatment than NZ European patients, at
20.0 days compared with 16.0 days. The authors note
that Māori patients with hematuria were, on average,
younger than NZ European patients and that Māori
with bladder cancer have experienced approximately
37% higher mortality than non-Māori. Cxbladder Triage
did not eliminate these inequities, but the pathway
narrowed elements of the access gap while improving
overall system performance.
These published data continue to support our
work with Te Whatu Ora on more consistent access
across New Zealand, and it is directly relevant to
other capitated systems like the integrated delivery
networks (IDNs) in the US and payers that ask whether
Cxbladder can increase the patient load that can
be maintained by a urologist, reduce unnecessary
procedures and free urologist capacity without
compromising cancer detection.
7
1
Eaton, D., Kerdemelidis, M., Losco, G., Mark, S., Patu, M., Elliot, N., & Frampton, C. (2026). Cxbladder triage in haematuria assessment reduces time from referral to specialist
assessment and bladder cancer treatment and improves equity for Māori. ANZ Journal of Surgery.
2
Davidson, PJ, McGeoch, G, Shand, B. Inclusion of a molecular marker of bladder cancer in a clinical pathway for investigation of haematuria may reduce the need for
cystoscopy. NZ Med J 2019; 132:1497; Davidson P, McGeoch G, Shand B. Assessment of a clinical pathway for investigation of haematuria that reduces the need for
cystoscopy. NZ Med J 2020. 133:1527
NZ HEMATURIA STUDY
Canterbury pathway evidence shows faster
care and fewer referrals
Median
waiting time
from primary
care referral to
urological specialist
appointment
reduced by 14.8
days

Our AUSSIE study has been accepted for
publication in the respected BJUI
1
providing important
new evidence that Triage Plus performs consistently
across different patient populations and health
systems, while strengthening the clinical case for
adoption in Australia.
The study – the second peer reviewed clinical
validation of Triage Plus and the first in an Australian
population – reproduces the performance seen in
DRIVE
2
, contributes to planned pooled analyses with
DRIVE and microDRIVE, and gives Australian clinicians
and hospitals local peer-reviewed evidence to support
adoption and contracting discussions.
The study enrolled 691 evaluable patients presenting
with visible (gross) or non-visible (micro) hematuria
across four Australian hospital urology clinics between
September 2023 and August 2025. Importantly, the
test-negative rate (anticipated rule-out rate) was 74%.
This is a key driver of the potential economic value
of Triage Plus, as a higher test negative rate creates
greater opportunity for health systems to avoid
unnecessary cystoscopies and their associated costs.
The study analyzed microhematuria and gross
hematuria patients separately, with test-negative rates
of 81% in microhematuria (NPV 100%) and 70% in gross
hematuria (NPV 98%). Within the microhematuria
population, test-negative rates were 100% in low-risk
patients (NPV 100%), 89% in intermediate-risk patients
(NPV 100%), and 76% in high-risk patients (NPV
99%). These results provide a clear demonstration
of the utility of Triage Plus across the spectrum of
hematuria risk. NPV remained at or above 99% across
all microhematuria risk categories, while the proportion
of patients testing negative appropriately declined as
underlying disease risk increased.
The AUSSIE findings are further strengthened when
considered alongside the DRIVE and microDRIVE
validation studies. Collectively, these data reinforce
our confidence that the AUA will further refine its
microhematuria guidelines during its next literature
review cycle (anticipated no earlier than June 2027).
Our objective is to secure an evidence-based expansion
of the patient populations eligible for risk stratification
using Triage Plus. The AUSSIE study provides an
important opportunity to accelerate adoption of Triage
Plus in Australia by giving clinicians locally generated
evidence of its performance within the Australian
healthcare setting.
8
AUSSIE STUDY PUBLISHEDWILLY IGLESIAS, CHIEF DIGITAL OFFICER
Australian validation for
Triage Plus
We appointed Willy
Iglesias as Chief Digital
Officer during the
quarter. Willy brings
extensive experience in
healthcare technology,
cybersecurity,
information
governance and digital
transformation, gained
across healthcare,
government and
multinational technology
organizations.
His brief is commercial: to make a small
company capable of serving a very large market
driving efficiencies in which increases in revenue
will outpace increases in cost. As Medicare
coverage is finalized and US volumes grow,
our ability to integrate with hospital electronic
medical records, to capture the documentation
that supports a clean claim, and to give our sales
team reliable data on account performance will
determine how quickly we can scale, and how
much of that growth reaches the bottom line.
Willy is charged with delivery of these systems
and integrations. He says: “I see a clear role for
digital and artificial intelligence to drive scalable
growth by making Cxbladder easier to adopt,
integrate and use within clinical workflows. Done
well, that improves the customer experience,
supports more efficient commercial execution and
embeds Cxbladder more deeply into everyday
clinical practice.”
His immediate priorities are integration
across our CRM, ERP and laboratory information
systems, stronger information security and data
governance, better reporting
for our commercial
and revenue cycle
teams, and the
foundations
required to
apply artificial
intelligence to
our data assets
and commercial
operations.
Building the digital backbone
for growth
“I see a clear
role for digital and AI
to drive scalable growth
by making Cxbladder
easier to adopt,
integrate and use within
clinical workflows.”
1
Buhariwalla V, Sethi K, Vela I, Hayne D, Atchia Z, de Lange M, Lough T, White A,
Ranasinghe W. Validation of Cxbladder Triage Plus in Australian Patients with
Haematuria: The AUSSIE Study. Accepted for publication in the BJU International; 2026.
2
Savage et al (2025) 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.

CLINICAL EVIDENCE
Evidence to drive clinical practice change
Our clinical study program is a key pillar of how Pacific Edge drives value. We are focused on generating the
compelling clinical evidence required to drive behavior change in physicians, 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 (lower
risk MH) and
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
• Final analysis publication is being developed, will
confirm published findings and is expected in 2027
DRIVE
Detection and Risk
stratification In
VEterans presenting
with hematuria
• CV of Triage Plus
(MH or GH)
• Data for MH & GH
pooled analyses
• MH and GH
• Risk stratification
• Enrolment closed with 710 patients including 48
tumour confirmed patients from 10 US VA sites
• Database lock completed and manuscript published
microDRIVE
Detection and Risk
stratification In
VEterans presenting
with microhematuria
• CV of Triage Plus
(MH or GH)
• Data for MH & GH
pooled analyses
• MH
• Risk stratification
• Final monitoring is complete for 667 consented
patients including 36 confirmed with urothelial
carcinoma
• Database lock was achieved Sep-2026 with data
analysis to follow in Oct
• Publication is targeted for Q1-2027
AUSSIE
Australian Urologic
risk Stratification
of patientS wIth
hEmaturia
• CV Triage Plus
(MH or GH)
• Data for MH & GH
pooled analyses
• MH and GH
• Risk stratification
• There are 691 evaluable subjects enrolled including
54 confirmed bladder tumor patients (10 MH UC;
43 GH UC; 1 adenocarcinoma)
• Accepted for publication
POOLED ANALYSES• CV Triage Plus
(MH & GH) pooled
analysis
• MH and GH
• Risk stratification
• MH patient data from DRIVE, AUSSIE & microDRIVE
from 1053 patients will be analysed with publication
expected Q2-2027
• Separately GH patient data from 762 patients will be
analysed with publication expected Q2-2027
CREDIBLE
Cystoscopic
REDuction In
BLadder Evaluations
for microhematuria
• CU Triage Plus • MH
• Risk stratification
• Currently 335 patients are enrolled of 1000 targeted
• Enrollment phase expected to continue until Q2 to
Q3-2027
LOBSTER
LOngitudinal Bladder
cancer Study for
Tumor Recurrence
• CV Cxbladder
Surveillance
(low-, int.- and
high-risk)
• Surveillance
• Risk stratification
• Currently there are 448 subjects enrolled with
approximately 1336 samples
• Enrolment was completed Q4-25 having achieved our
enrolment target of 75 confirmed urothelial carcinoma
recurrences (99 patients had at least one recurrence)
• Data monitoring is expected to continue until April-2027
with full database lock targeted for May-2027
• Sample collection will continue with <50 expected, at
scheduled surveillance visits through to Dec-26
OCTOPUS
Ongoing Cxbladder
Testing for Optimized
Patient Experience
in Urothelial
Surveillance
• CU Cxbladder
Surveillance
(low-, int.- and
high-risk)
• Surveillance
• Risk stratification
• Currently at the planning stage. Advisory Board
completed Dec-2025 and protocol synopsis developed
9
• Microhematuria (MH), Gross hematuria (GH), Urothelial Cancer (UC)
• Cxbladder Monitor Plus is now called Cxbladder Surveillance Plus
• Quarterly dates are calendar year not financial year

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