Cxbladder Test Volumes Steady in Q1 25

10 JULY 2024


CXBLADDER TEST VOLUMES STEADY IN Q1 25
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today
announces tests processed at its laboratories in the three months to the end of June 2024 were
steady on the prior quarter (Q4 24) as we continued to benefit from improved performance
from a lean sales force in the US, an acceleration of demand in New Zealand and sustained
growth from Kaiser Permanente.
Volumes in Q1 25 flattened to 7,188 tests, a figure down 0.3% on the 7,210 tests in Q4 24. US
volumes were 5,905 tests down 3.2% on the 6,099 in Q4 24. The result follows from a further
reduction in our direct sales team and previously reported improvements in sales force
efficiency alongside a growing contribution from Kaiser Permanente following the incorporation
of Cxbladder into its electronic medical records system.
Q1 25 saw another reduction in US account executives, down to an average of 15 FTEs across
the quarter from 16 FTEs in Q4 24. This drop follows a decision to limit backfilling of commercial
staff while Medicare reimbursement uncertainty continues.
The combination of fewer FTEs and the increased Kaiser Permanente volumes has lifted our
sales force efficiency metric (403 tests per average sales FTE in Q1 25 vs 381 in Q4 24 and
288 in the same period a year ago).
In the US, tests per ordering clinician (our preferred metric for measuring customer
commitment to Cxbladder) increased to 6.8 in Q1 25, from 6.7 in Q4 24 reflecting ongoing
efficiency improvements, our enhanced sales messaging, which focuses on the clinical value
of Cxbladder in the evaluation of hematuria, and again the impact of the increased Kaiser
Permanente volumes.
Asia Pacific volumes were up 15.5% on Q4 24 to 1,283 tests. The region benefited from an
increase in demand from New Zealand for surveillance evaluations in particular (Cxbladder
Monitor volumes were up 17%). The result also benefited from demand from new regions in
the South Island delivering samples. Volumes from Australia and Asia reached a new quarterly
record although totals remain small.
Further details on test volumes and other developments in the quarter are included in the
investor update released today.
Released for an on behalf of Pacific Edge by Grant Gibson, Chief Financial Officer.
For more information:
Investors: Media:
Dr Peter Meintjes Richard Inder
Chief Executive The Project
Pacific Edge P: +64 21 645 643
P: 022 032 1263

OVERVIEW
Pacific Edge: www.pacificedgedx.com
Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way
in the development and commercialization of bladder cancer diagnostic and prognostic tests
for patients presenting with hematuria or surveillance of recurrent disease. Headquartered in
Dunedin, New Zealand, the company provides its suite of Cxbladder tests globally through its
wholly owned, and CLIA certified, laboratories in New Zealand and the USA.
Cxbladder: www.cxbladder.com
Cxbladder is a urine-based genomic biomarker test optimized for the detection and surveillance
of bladder cancer. The Cxbladder evidence portfolio developed over the past 14 years includes
more than 20 peer reviewed publications for primary detection, surveillance, adjudication of
atypical urine cytology and equivocal cystoscopy. Cxbladder is the focal point of numerous
ongoing and planned clinical studies to generate an ever-increasing body of clinical utility
evidence supporting adoption and use in the clinic to improve patient health outcomes.
Cxbladder has been trusted by over 4,400 US urologists in the diagnosis and management of
more than 100,000 patients, including the option for in-home sample collection. In New
Zealand, Cxbladder is accessible to 75% of the population via public healthcare and all
residents have the option of buying the test online.

---

INSIDE
Letter from the CEO 2
Q1 25 test volumes 3
Cxbladder Detect
+
pricing 5
Patient survey: surveillance 6
Bladder Cancer Awareness Month 7
Clinical study program update 8
JULY 2024

PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2024
2
LETTER FROM THE CEO
LOOKING TO THE CATALYSTS
OF THE FIRST QUARTER
Dear Shareholders,
The first quarter of the 2025
financial year will be the
last quarter before we learn
how Novitas, our Medicare
Administrative Contractor, has
responded to our comments and
finalizes DL39365.
Once again, I’m tremendously
proud of the team at Pacific Edge;
one that has delivered on key
strategic milestones and sustained
commercial performance despite
the uncertainty regarding Medicare
reimbursement for Cxbladder.
Test volumes processed through
our laboratories were steady
over Q4 24, down 0.3% to 7,188
(see pages 3 and 4). Laboratory
throughput was supported by
a strong performance from our
APAC operation, led primarily
by growth in the New Zealand
market and a sustained growth
trajectory from our US customer
Kaiser Permanente. These gains
were diluted by attrition in the sales
force as we have continued to limit
the backfilling of commercial staff
while Medicare reimbursement
uncertainty continues.
As I highlighted in our Annual
Report released at the end of June,
Q2 25 is likely to feature three
significant developments that will
be highly determinative of our
results for the current financial year
and our strategy at least for the
short to medium term.
Novitas is expected to finalize
the draft LCD ‘Genetic Testing for
Oncology’ (DL39365) by the end
of July including a response to all
submitted comments. This final
LCD directly affects the Medicare
reimbursement of our Cxbladder
tests and the rate of adoption.
By September we are also
expecting the Centers for
Medicare and Medicaid Services
to have reviewed our proposal
for a Cxbladder Detect
+
price of
approximately $1,590 (see page
5). Detect
+
delivers significant
performance improvements over
our existing tests thanks to its
incorporation of DNA biomarkers
of bladder cancer. A favorable
outcome for Detect
+
pricing is
expected to significantly increase
the value of our total addressable
market, improve the economics
of promoting our tests, and if
supported by positive language
in the microhematuria guidelines,
accelerate the rate of adoption by
clinicians and healthcare payers.
Finally, we will also soon learn
if our recently released STRATA
1

study, which demonstrated the
clinical utility of Cxbladder Triage
to risk stratify microhematuria
patients, is sufficient to convince
the American Urological
Association to make an amendment
to the 2020 guidelines for the
evaluation and management of
hematuria. A favorable outcome
(coupled with a positive Medicare
coverage determination) would
entrench Medicare coverage
of Cxbladder, drive demand
with physicians and patients
and improve our ability to
influence coverage by private
healthcare payers. In the event
of a Medicare non-coverage
determination, guidelines inclusion
would significantly increase the
probability of regaining coverage.
“A favorable outcome
for Detect
+
pricing
is expected to
significantly increase
the value of our total
addressable market,
improve the economics
of promoting our tests,
and if supported by
positive language in
the microhematuria
guidelines, accelerate
the rate of adoption
by clinicians and
healthcare payers.”
We expect all these matters
to be settled before our Annual
Shareholder Meeting to be held on
24 September 2024 in Auckland.
Consequently, in keeping with the
approach we took last year, we
intend at this meeting to offer a
1
Lotan et al. (2024). A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The Safe Testing
of Risk for Asymptomatic Microhematuria Trial. (In Press) The Journal of Urology Vol 212 1-8 Jul 2024.

‘deeper dive’ into the business with
presentations from our Chair, Chris
Gallaher, myself as well as other
senior management. It will also be
the last time Chris and Mark Green
attend the meeting as Directors of
the company and we look forward
to the opportunity to acknowledge
and celebrate their contribution.
While the last 12 months have
been unsettling for investors, I
remain steadfast in the view that
even in the event of short-term
adversity, the long-term view for
Pacific Edge remains one of rapid,
sustained growth once we gain
certainty over Medicare’s continued
coverage of our tests. The key
question is – in the face of these
immediate developments – how we
execute on the opportunities before
us to achieve that goal.
We will update Shareholders
ahead of the ASM with the agenda,
and with these key events resolved,
I am confident that we can provide
transparent insight into our
strategy and answer any questions
you may have.
I look forward to seeing you there.
Best regards,
Dr Peter Meintjes
Chief Executive
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2024
3
LETTER FROM THE CEO CONTINUED
TEST VOLUMES
US SALES TEAM SUSTAINS PERFORMANCE IMPROVEMENTS
Tests processed through our laboratories in the three months to the end of June 2024 were steady on the prior
quarter (Q4 24) as we continued to benefit from improved performance from a lean sales force in the US, an
acceleration of demand in New Zealand and sustained growth from Kaiser Permanente.
Volumes in Q1 25 flattened to 7,188 tests, a figure down 0.3% on the 7,210 tests in Q4 24. US volumes were
5,905 tests down 3.2% on the 6,099 in Q4 24. The result follows from a further reduction in our direct sales team
and previously reported improvements in sales force efficiency alongside a growing contribution from Kaiser
Permanente following the incorporation of Cxbladder into its electronic medical records system.
Q1 25 saw another reduction in US account executives, down to an average of 15 FTEs across the quarter from
16 FTEs in Q4 24. This drop follows a decision to limit backfilling of commercial staff while Medicare reimbursement
uncertainty continues. The combination of fewer FTEs and the increased Kaiser Permanente volumes has lifted our
sales force efficiency metric (403 tests per average sales FTE in Q1 25 vs 381 in Q4 24 and 288 in the same period a
year ago).
In the US, tests per ordering clinician (our preferred metric for measuring customer commitment to Cxbladder)
increased to 6.8 in Q1 25, from 6.7 in Q4 24 reflecting ongoing efficiency improvements, our enhanced sales
messaging, which focuses on the clinical value of Cxbladder in the evaluation of hematuria, and again the impact of
the increased Kaiser Permanente volumes.
Asia Pacific volumes were up 15.5% on Q4 24 to 1,283 tests. The region benefited from an increase in demand
from New Zealand for surveillance evaluations in particular (Cxbladder Monitor volumes were up 17%). The result
also benefited from demand from new regions in the South Island delivering samples. Volumes from Australia and
Asia reached a new quarterly record although totals remain small.

-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
Q1 22
4,277
1,079
5,356
Q2 22
4,706
1,074
5,780
Q3 22
4,591
1,117
5,708
Q4 22
5,290
952
6,242
Q1 23
6,073
983
7,056
Q2 23
6,699
1,165
7,864
Q3 23
6,629
1,139
7,768
Q4 23
1,061
8,877
Q1 24
8,627
1,079
9,706
Q2 24
7,335
1,199
8,534
Q3 24
6,041
1,142
7,183
Q1 25
5,905
1,283
7,188
Q4 24
6,099
1,111
7,210
APAC
-
200
400
600
800
1,000
1,200
1,400
1,600
-
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
US Ordering Clinicians
Tests/Clinician
US ORDERING CLINICIANS (LHS)
Q1 22
657
Q2 22
690
Q3 22
741
Q4 22
789
Q1 23
895
Q1 25
869
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
915
TESTS/ORDERING CLINICIANS (RHS)
7.0
6.5
6.8
6.2
6.1
6.7
6.8
6.8
6.4
6.8
-
10
20
30
40
50
60
-
50
100
150
300
200
250
70350
80400
Average Sales FTE
Average US Test Volume/Sales FTE
US AVERAGE SALES FTE (LHS)US TEST VOLUMES/SALES FTE (RHS)
200
202
160
187
222
226
201
239
288
265
21
Q1 22
23
Q2 22
29
Q3 22
28
Q4 22
27
Q1 23

30
Q2 23
33
Q3 23
33
Q4 23
30
Q1 24
28
Q2 24
21
Q3 24
16
Q4 24
15
Q1 25
292
5.9
6.8
6.7
381
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
Q1 22
4,277
1,079
5,356
Q2 22
4,706
1,074
5,780
Q3 22
4,591
1,117
5,708
Q4 22
5,290
952
6,242
Q1 23
6,073
983
7,056
Q2 23
6,699
1,165
7,864
Q3 23
6,629
1,139
7,768
Q4 23
1,061
8,877
Q1 24
8,627
1,079
9,706
Q2 24
7,335
1,199
8,534
Q3 24
6,041
1,142
7,183
Q1 25
5,905
1,283
7,188
Q4 24
6,099
1,111
7,210
APAC
-
200
400
600
800
1,000
1,200
1,400
1,600
-
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
US Ordering Clinicians
Tests/Clinician
US ORDERING CLINICIANS (LHS)
Q1 22
657
Q2 22
690
Q3 22
741
Q4 22
789
Q1 23
895
Q1 25
869
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
915
TESTS/ORDERING CLINICIANS (RHS)
7.0
6.5
6.8
6.2
6.1
6.7
6.8
6.8
6.4
6.8
-
10
20
30
40
50
60
-
50
100
150
300
200
250
70350
80400
Average Sales FTE
Average US Test Volume/Sales FTE
US AVERAGE SALES FTE (LHS)US TEST VOLUMES/SALES FTE (RHS)
200
202
160
187
222
226
201
239
288
265
21
Q1 22
23
Q2 22
29
Q3 22
28
Q4 22
27
Q1 23

30
Q2 23
33
Q3 23
33
Q4 23
30
Q1 24
28
Q2 24
21
Q3 24
16
Q4 24
15
Q1 25
292
5.9
6.8
6.7
381
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
Q1 22
4,277
1,079
5,356
Q2 22
4,706
1,074
5,780
Q3 22
4,591
1,117
5,708
Q4 22
5,290
952
6,242
Q1 23
6,073
983
7,056
Q2 23
6,699
1,165
7,864
Q3 23
6,629
1,139
7,768
Q4 23
1,061
8,877
Q1 24
8,627
1,079
9,706
Q2 24
7,335
1,199
8,534
Q3 24
6,041
1,142
7,183
Q1 25
5,905
1,283
7,188
Q4 24
6,099
1,111
7,210
APAC
-
200
400
600
800
1,000
1,200
1,400
1,600
-
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
US Ordering Clinicians
Tests/Clinician
US ORDERING CLINICIANS (LHS)
Q1 22
657
Q2 22
690
Q3 22
741
Q4 22
789
Q1 23
895
Q1 25
869
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
915
TESTS/ORDERING CLINICIANS (RHS)
7.0
6.5
6.8
6.2
6.1
6.7
6.8
6.8
6.4
6.8
-
10
20
30
40
50
60
-
50
100
150
300
200
250
70350
80400
Average Sales FTE
Average US Test Volume/Sales FTE
US AVERAGE SALES FTE (LHS)US TEST VOLUMES/SALES FTE (RHS)
200
202
160
187
222
226
201
239
288
265
21
Q1 22
23
Q2 22
29
Q3 22
28
Q4 22
27
Q1 23

30
Q2 23
33
Q3 23
33
Q4 23
30
Q1 24
28
Q2 24
21
Q3 24
16
Q4 24
15
Q1 25
292
5.9
6.8
6.7
381
403
7,816
FIGURE 1: TOTAL TEST VOLUMES
1
FIGURE 2: CXBLADDER CLINICAL ADOPTION
FIGURE 3: US SALES FORCE EFFICIENCY
TEST VOLUMES CONTINUED
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2024
4
1
Volumes in some prior quarters of FY24 are marginally different from those reported in earlier investor updates reflecting post period adjustments.

ACKNOWLEDGING OUR TECHNOLOGICAL ADVANCES
CXBLADDER DETECT
+
PRICING
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2024
5
If CMS shares our view and agrees that Detect
+

should attract a price of US$1,590, Pacific Edge
would gain significant upside to our existing market
opportunity for hematuria evaluation. The value of the
total addressable market would grow, our margin per
test would increase, the profitability profile of operating
a sales resource would increase and the risk associated
with scaling our sales force would decrease.
Coupled with the known published improvements
for Detect
+
and any future guidelines inclusion, the
rate of adoption by clinicians and healthcare payers
would also be expected to increase, significantly
changing the outlook for Pacific Edge.
The CMS price for Detect
+
sets the amount Pacific
Edge will be reimbursed for all patients with Medicare
and Medicare Advantage insurance (assuming a
positive coverage decision). While private health
insurance companies make separate coverage
decisions based on their own medical policy for a
test, the CMS price typically sets a benchmark for
non-contracted reimbursement and contracting
negotiations.
Pacific Edge publicly set out its arguments at the
CMS Clinical Lab Fee Schedule (CLFS) annual meeting
held at the end of June. Our team led by David Sosa,
Vice President of Market Access, argued CMS should
Crosswalk the price for Detect
+
to a combination
of Cxbladder Detect (with a price of US$760) and
an HPV
1
cancer test called NavDx (with a price
of US$827.69) developed by US precision cancer
company Naveris. NavDx is the only dd-PCR based
MAAA (multi-analyte with algorithmic analysis) test
with a price in the CLFS, and consequently, we believe
this is the most appropriate Crosswalk candidate
based on the technology and resource usage involved
in performing a Detect
+
test.
If CMS agrees with our Crosswalk proposal, we
expect to be notified by the time we gather for our
annual meeting in September. The price will then be
subject to a ‘Notice and Comment’ period of 60 days
before finalization and becoming effective on
1 January 2025.
However, if CMS does not agree with our Crosswalk
proposal, it may choose an alternative technology
match from their database with a different price or
direct Pacific Edge to a ‘Gap Fill’ process, potentially
delaying pricing by another year. We remain optimistic
about CMS’ assessment and its potential impact on
Pacific Edge’s financial performance.
1
HPV Human papillomavirus
Pacific Edge has made what we believe is a compelling case for the Centers for Medicare and Medicaid
Services (CMS) to price Cxbladder Detect
+
via ‘Crosswalk’, a process that acknowledges the advancement of
incorporating both RNA and DNA markers for the detection of bladder cancer in patient samples.

SURVEY: PATIENTS SHOW STRONG
INTEREST IN NON-INVASIVE
ALTERNATIVES TO CYSTOSCOPY
BLADDER CANCER SURVEILLANCE
Patients being monitored for recurrent bladder cancer are
interested in non-invasive test alternatives to minimize the discomfort
and anxiety associated with cystoscopy.
That is the finding of a new survey of 1,507 US patients conducted
by Pacific Edge working with the Bladder Cancer Advocacy Network
(BCAN).
Asked about their experience with cystoscopy, 42% of patients
indicated that they felt ‘moderate’ to ‘extreme’ discomfort during the
procedure. Meanwhile, 78% of patients indicated that they experienced
some pain, and 25% indicated that the pain was ‘moderate’ to ‘the
worst imaginable’. Furthermore, 56% of patients indicated that they
experienced ‘moderate’ to ‘extreme’ anxiety.
All patients in the survey were registered with BCAN’s Patient
Survey Network and were being monitored for recurrent non-muscle
invasive bladder cancer (NMIBC).
When presented with introductory information on Cxbladder
Monitor, a non-invasive urine test with the option of in-home sampling
that can help reduce the frequency of surveillance cystoscopy, 38%
of patients were willing to incorporate the test into their monitoring
schedule while a further 51% were interested and wanted to learn more.
Of significant note, 80% of patients rated the availability of urine-
based test options as moderately to extremely important. Despite this,
82% were unaware of leading test options such as Cxbladder Monitor
and 80% reported they had not discussed non-invasive test alternatives
with their doctor.
The results of the survey also suggest non-invasive diagnostic tools
such as Cxbladder Monitor may help to address an ongoing issue
with patient compliance. Recent American Urological Association
(AUA) data
2
suggests that the average length of follow-up monitoring
among NMIBC patients is just 1.8 years
2
. This is in sharp contrast to
the AUA guidelines which recommend regular cystoscopies for all risk
categories until at least 5 years after the most-recent removal of a
tumor. For high and intermediate risk patients, the expectation is that
scheduled checks continue indefinitely.
Pacific Edge Chief Medical Officer Tamer Aboushwareb said: “If
applied to the right patient population, clinicians have an opportunity
to dramatically reduce the burden of surveillance for recurrence in their
NMIBC patients with Cxbladder Monitor, simultaneously maximizing
patient comfort and improving compliance with long-term monitoring.
Reducing the frequency of cystoscopy required and the travel
burden linked to in-clinic visits also has a societal benefit that is often
unrealized.”
Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy
Network said: “As the leading bladder cancer advocacy organization
in the United States, we know that patients are interested in having
less invasive ways to diagnose and monitor NMIBC. Safe, reliable and
effective non-invasive surveillance options are good news for patients.”
1
Survey: Surveillance Patients Show Strong Interest in Non-Invasive Test Options (cxbladder.com)
2
American Urological Association AQUA Registry Data
SURVEILLANCE PATIENTS
EXPERIENCE WITH
CYSTOSCOPY
1
42
%
INDICATED ‘MODERATE’
TO ‘EXTREME’
DISCOMFORT
56
%
INDICATED THAT THEY
EXPERIENCED
‘MODERATE’ TO
‘EXTREME’ ANXIETY
78
%
OF PATIENTS
INDICATED THAT
THEY EXPERIENCED
SOME PAIN
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2024
6

BLADDER CANCER AWARENESS MONTH
GLOBAL TEAMS RALLY BEHIND OUR MISSION
In May Pacific Edge joined with organizations around the world including the Bladder Cancer Advocacy
Network (BCAN) to support Bladder Cancer Awareness Month.
Bladder Cancer Awareness Month is a time for those affected by bladder cancer to stand together and
raise awareness of the disease while working to better support its care. Every year, over 610,000 people are
diagnosed with bladder cancer around the world, and more than 1.9 million people are living with the disease.
Globally, bladder cancer is the ninth most diagnosed cancer, and the sixth most common among men
1
.
This year, in response to recent patient survey findings and
AUA data suggesting surveillance compliance remains an
ongoing challenge (see page 6 for more detail), we led
with the campaign message ‘Stay on track’. This message
encouraged patients being monitored for recurrent NMIBC
to keep up with scheduled surveillance check-ups. To help
ease the burden of invasive testing, the campaign promoted
Cxbladder Monitor as a non-invasive alternative to surveillance
patients that can reduce the frequency of cystoscopy.
We anchored the ‘Stay on track’ campaign activity with the placement of collateral in urology clinics
across the US and communication of patient survey findings. Our teams around the world then worked
to raise the profile of Bladder Cancer Awareness Month with an orange themed dress up. This initiative
was promoted across our digital channels alongside social media posts designed to increase awareness of
bladder cancer symptoms and risk factors. ‘Stay on track’ social media posts reinforced the importance of
regular surveillance checks to ensure early detection of any recurrent disease.
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2024
7
1
https://worldbladdercancer.org/news_events/bladder-cancer-awareness-month-in-may-and-why-it-is-important/

OUR CLINICAL STUDY PROGRAM
BUILDING LONG TERM VALUE
STUDYGOALPOPULATION AND
USE
STATUS
STRATA
(Safe Testing of Risk
for AsymptomaTic
MicrohematuriA)
• CU for Triage
• CU for Detect
+

(retrospective)
• Microhematuria
• Risk stratification
- First paper published in the Journal of
Urology in May 2024 and presented at the
AUA annual conference
- Study sites will close late 2024 and final
study reports completed early 2025
DRIVE
(Detection and Risk
stratification In VEterans
presenting with
hematuria)
• CV for Detect
+
,
Detect & Triage
within a Veterans’
cohort
• Data for pooled
analysis
• Micro and gross
hematuria
• Risk stratification
- Enrolment closed with 710 patients across
10 Veterans Affairs sites
- Data cleanup underway and Detect
+
runs
expected Q3 2024
- Publication targeted for Q2 2025
microDRIVE
(Detection and Risk
stratification In VEterans
presenting with
hematuria)
• CV of Detect
+

• Data for pooled
analysis
• Microhematuria
• Detection
- Recruitment commenced November 2023
as a network study across all US Veterans
Affairs Medical Centers coordinated from a
single Veterans Affairs site
- 208 patients have been consented for the
study with 102 samples received to date
- The target is up to 1000 patients including
35 tumor confirmed patients
- Enrollment end is targeted for early 2025
and publication Q3 2025
AUSSIE
(Australian Urologic risk
Stratification of patientS
wIth hEmaturia)
• CV of Detect
+

with an Australian
cohort
• Data for pooled
analysis
• Micro and gross
hematuria
• Risk stratification
- Target enrolment: 600 patients across
three Australian sites
- Enrolment commenced September 2023
- 98 subjects are consented to the study and
93 samples have been received
- 2 sites enrolling and 1 further site expected
to commence within a month
- Target publication Q4 2025
POOLED ANALYSIS• CV of Detect
+
• Microhematuria
• Gross hematuria
• Risk stratification
- Microhematuria and separately Gross
Hematuria patients from DRIVE, AUSSIE
and microDRIVE will be pooled and
performance determined
- Target publication Q1 2026
LOBSTER
(LOngitudinal Bladder
cancer Study for
Tumor Recurrence)
• CV of Monitor/
Monitor
+
• Surveillance
• Risk stratification
- Target enrollment is 400-500 subjects
across 10 sites (US, Australia)
- A total of 321 subjects have consented to
the study with 532 samples received
- The enrolment phase is expected to end
early 2025
- Target publication Q1 2026
CREDIBLE
(Cystoscopic REDuction
In BLadder Evaluations
for microhematuria) - A
randomized, controlled,
clinical utility study for
hematuria evaluation
• CU of Detect
+
• Microhematuria
• Risk stratification
- Target enrolment is 1,000 subjects with an
interim analysis at 600 to determine if the
primary objective has been addressed
- First patient in targeted for Dec 2024
- 15 US sites anticipated
- Target publication Q1 2028
*Dates are calendar year not financial years
Our clinical study program is at the foundation of Pacific Edge’s value. We are focused on generating the
compelling clinical evidence required to drive behavior change in physicians that is founded on the frameworks of
Analytical Validity, Clinical Validity, and Clinical Utility, with the end points and sample sizes required for coverage
decisions and guideline inclusion.
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2024
8

ABOUT US
Pacific Edge Limited (NZX/ASX: PEB) is a global cancer diagnostics company leading the way in the development
and commercialization of bladder cancer diagnostic and prognostic tests for patients presenting with hematuria
or surveillance of recurrent disease. Headquartered in Dunedin, New Zealand, the company provides its suite of
Cxbladder tests globally through its wholly owned, and CLIA certified, laboratories in New Zealand and the USA.
VISIT US ONLINE:
www.pacificedgedx.com
www.cxbladder.com
FOLLOW US ON SOCIAL MEDIA:
www.facebook.com/PacificEdgeLtd
www.facebook.com/Cxbladder
www.twitter.com/PacificEdgeLtd
www.twitter.com/Cxbladder
www.linkedin.com/company/pacific-edge-ltd
CONTACT US:
Centre for Innovation
87 St David Street
PO Box 56
Dunedin 9016, New Zealandd
T: 0800 555 563 (NZ)
+64 3 577 6733 (Overseas)
E: investors@pacificedge.co.nz