Quarterly Update – Q2 24 Cxbladder Test Volumes Resilient

11 October 2023
CXBLADDER TEST VOLUMES RESILIENT IN THE FACE OF HEADWINDS
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) announces
test volumes processed at its laboratories in the second quarter of the 2024 financial year (Q2 24) fell
12% to 8,525 from 9,704 in the prior quarter (Q1 24) amid the reorganization of our US operations and
publicity on the Medicare coverage determinations.
However, the volume of tests processed in Q2 24 represents an 8% increase on the 7,864 tests
processed in the same quarter of the prior year (Q2 23). The reorganization, detailed in the company’s
Q1 24 investor update also released today, weighed on sales activity in August and early September.
Meanwhile, volumes were also impacted by some uncertainty among physicians and healthcare
providers over Cxbladder’s coverage status following the Medicare non-coverage determination in June
by Novitas and then its July withdrawal. These effects were exacerbated by the normal July holiday
season lull.
Tests processed in our US laboratory were 7,335 tests in Q2 24, a 15% decrease on the 8,627 tests in
Q1 24. The figure represents a 9% increase on the 6,699 tests processed in Q2 23. The number of
unique ordering clinicians in the US fell 7% through the quarter to 1,147 but is up 17.3% on the 978
clinicians who ordered tests in Q2 23.
Asia Pacific volumes in Q2 24 were 1,190 up 10% on the 1,077 tests processed in Q1 24, and up 2%
on the 1,165 tests processed in Q2 23 with the quarter-on-quarter increase largely reflecting an increase
in test volumes associated with clinical studies in the region.
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

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

in the diagnosis and management of more than 100,000 patients, including the option for in-home
sample collection. In New Zealand, Cxbladder is accessible to 75% of the population via public
healthcare and all residents have the option of buying the test online.

---

INSIDE
Letter from the CEO 2
Q2 24 test volumes 3
Selling the value of Cxbladder 4
Medicare coverage update 5
Detect
+
clears first hurdle 6
Cxbladder economics 7
CREDIBLE study ‘green lit’ 8
OCTOBER 23

PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2023
2
LETTER FROM THE CEO
BUILDING RESILIENCE
AMID CHANGE
Dear Shareholders,
The second quarter of the 2024
financial year was one of significant
challenge and change for Pacific
Edge. Despite this operating
environment, Cxbladder throughput
was 8,525 tests for the quarter,
which is down 12% on prior quarter,
but still our third highest quarter
and an increase of 8% over the same
quarter in the prior year.
We started the quarter with
Novitas, our Medicare Administrative
Contractor, finalizing ‘Genetic
testing for oncology’ (L39365) as
‘future effective’, a move that was
set to end Medicare coverage of our
tests.
However, following pressure
from Pacific Edge, peer companies,
industry partners, healthcare
providers and the clinical
community, the determination
was withdrawn, and a new, albeit
unchanged draft (DL39365), was
released for public review and
comment in line with statutorily
regulated procedures.
This very welcome decision
returned Pacific Edge to a condition
we have endured for much of the
last year. We remain a covered
benefit by Medicare and continue
to receive reimbursement for our
tests. Yet once again we are having
to make the case that Cxbladder is
medically reasonable and necessary
despite historical coverage from
Novitas clearly indicating that this
is the case. With uncertainty over
whether our message will be heard,
and uncertainty regarding when the
determination will be finalized, there
is naturally uncertainty regarding
how long Medicare coverage will
continue.
Notwithstanding the strength of
our existing clinical evidence, the
strength of our written arguments
to Novitas, and the strong support
we have received from the most
significant organizations in the US
urology community (see page 5),
the risks of a non-coverage decision
are now more elevated than we
assessed for much of the last year.
“Our operations are now
configured to ride out a
non-coverage
determination...”


In response we have restructured
our business (see page 4) to reduce
our cash burn. This contrasts
with our prior focus on top line
revenue growth. The approach
we have taken is in line with our
communications to investors at the
Annual Shareholder Meeting in July.
Our operations are now configured
to ride out a non-coverage
determination and regain Medicare
coverage relying on our existing
capital reserves.
We now have a smaller sales
force. Each team member has a
larger territory, where the focus
is on territory profitability, not
throughput growth alone. The team
is adopting refined value-based
messaging to healthcare providers
and clinicians emphasizing that
the greatest clinical and economic
value of Cxbladder is realized if
the tests are protocolized in the
clinical pathway to safely avoid or
defer cystoscopies and imaging for
hematuria evaluation or bladder
cancer surveillance (see page 4).
We are supporting this change
by better equipping the team
with marketing collateral and
digital technologies to ensure that
clinicians - having determined the
clinical utility of Cxbladder for
themselves - elect to protocolize our
tests systematically on every eligible
patient type. We are also seeking
to facilitate this decision by offering
a seamless ordering and results
delivery experience.
We continue our evidence
generation activities with a focus
on the end points required for
inclusion of Cxbladder in the
clinical guidelines of the American
Urological Association (AUA)
and the National Comprehensive
Cancer Network (NCCN). Guideline
inclusion, as we have noted before,
remains the most effective strategy
to entrench coverage of our tests
(see page 8).
Finally, just as the quarter
closed, the US Food and Drug
Administration (FDA) has proposed
rule changes that could see
Cxbladder falling under its oversight
and regulated as a medical device.
We highlight our views on the
relevance of this development in the
context of the complex history and
legal challenges associated with the
various ebbs and flows on this topic
over the last couple of decades on
page 7.
Ngā mihi nui,
Dr Peter Meintjes
Chief Executive

UNIQUE ORDERING CLINICIANS: US
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
USNZ
Q4 21
3,824
1,073
Q1 22
4,277
1,079
Q2 22
4,706
1,074
Q3 22
4,591
1,117
Q4 22
5,290
952
Q1 23
6,073
983
Q2 23
6,699
1,165
Q3 23
6,629
1,139
Q4 23
7,817
1,061
Q1 24
8,627
1,077
Q2 24
7,335
1,190
Q3 21
3,110
943
Q2 21
2,791
1,088
TOTAL TEST VOLUMES: GROUP
PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2023
3
TES
T VOLUMES
RESILIENT THROUGHPUT DESPITE HEADWINDS
Test volumes processed at Pacific Edge’s laboratories in the second quarter of the 2024 financial year (Q2
24) fell 12% to 8,525 from 9,704 in the prior quarter (Q1 24) amid the reorganization of our US operations and
publicity on the Medicare coverage determinations. The volume of tests processed in Q2 24 represents an 8%
increase on the 7,864 tests processed in the same quarter of the prior year (Q2 23).
The reorganization (see page 4) weighed on sales activity in August and early September. Meanwhile, volumes
were also impacted by some uncertainty among physicians and healthcare providers over Cxbladder’s coverage
status following the Medicare non-coverage determination in June by Novitas and then its July withdrawal. These
effects were exacerbated by the normal July holiday season lull.
Test s processed in our US laboratory were 7,335 tests in Q2 24, a 15% decrease on the 8,627 tests in Q1 24. The
figure represents a 9% increase on the 6,699 tests proce ssed in Q2 23. The number of unique ordering clinicians in
t
he US fell 7% through the quarter to 1,147 but is up 17% on the 978 clinicians who ordered tests in Q2 23.
Asia Pacific volumes in Q2 24 were 1,190 up 10% on the 1,077 tests processed in Q1 24, and up 2% on the
1,165 tests processed in Q2 23 with the quarter-on-quarter increase largely reflecting an increase in test volumes
associated with clinical studies in the region.
-
200
400
600
800
1,000
1,200
1,400
Physicians
Q3 21
516
Q4 21
530
Q2 21
462
Q1 22
657
Q2 22
690
Q3 22
741
Q4 22
789
Q1 23
895
Q2 23
978
Q3 23
1,082
Q4 23
1,150
Q1 24
1,232
Q2 24
1,147

RESTRUCTURE & INVESTMENT
CHARTING A COURSE TO ENTRENCHED COVERAGE
Guided by the principles we set out at our Annual
Shareholders’ Meeting in July we have completed the
strategic restructure we flagged for our US and Asia
Pacific operations.
With this smaller organization, we will continue to
focus on growth from Account Executives in larger
territories, from national accounts and capitated
systems and from global market opportunities. In the
event of an adverse Medicare coverage determination,
we are also positioned to make further changes while
continuing to pursue a course to regain coverage
within our existing reserves.
In practical terms this has seen a reduction in the
number of US sales territories from 29 to 17 and a
reduction of the US sales regions from three to two.
In the Asia Pacific our renewed focus is on growth
markets in Australia and Southeast Asia. This approach
recognizes that the primary opportunity for growth in
New Zealand would be from a national contract with Te
Whatu Ora that may take some time to develop.
We continue to invest in enhancing our sales
capability (see above) and to amplify our clinical
development program within the urology and oncology
communities, supporting our efforts to see the
inclusion of our tests in clinical guidelines.
Alongside this we have stepped up our investment
in clinical studies with the CREDIBLE clinical study
(see page 8).
Guideline inclusion, an expanding portfolio of
evidence supporting the clinical utility of our tests, and
strong medical communications are the best way to
entrench coverage. In the event of an adverse Medicare
local coverage determination, they are also the best
strategies to ensure we follow the fastest route to
regaining coverage.
Finally, we are driving improvements in the
performance and efficiency of our operations with the
continuing drive towards digitalization. This includes
efforts to:
• improve the customer experience and data
provenance to our lab with integrations into our
customers’ Electronic Medical Records (EMR)
systems,
• create a customer portal for managing test
requests, test results and documentation required
for establishing medical necessity, and
• the ability to electronically manage patient
recruitment, patient data, monitor clinical study
sites and analyze data for clinical and research
applications.
NATIONAL SALES MEETING
SELLING THE VALUE OF CXBLADDER
‘Cxbladder can help reduce the number of unnecessary procedures in your office and prioritize patients
that need further investigations.’ That was the focal point of new messaging to clinicians introduced at
our US national sales meeting held in Denver in the middle of September.
Across several sessions the Medical Affairs Team linked Cxbladder utility pathways to existing American
Urological Association (AUA) guidelines to drive the adoption of our tests.
For clinicians using Cxbladder Detect this means that they can safely rule out 78 of every 100 patients
presenting with microhematuria from receiving cystoscopy and imaging procedures when compared to
following the AUA guidelines without Cxbladder Detect.
For clinicians using Cxbladder Monitor this means that they can safely reduce the number of post-
surgery cystoscopies by 50%, and also continue to non-invasively monitor patients that may have recurrent
disease after guidelines no longer recommend invasive monitoring procedures.
This creates benefits to patients who present with comorbidities that elevate the procedural risks of
cystoscopies and delivers the clinical benefits of not missing any serious disease. It is also economically
beneficial to healthcare payers, enabling them to minimize unnecessary procedures, and
make more efficient use of staff time and facilities (see page 7).
Alongside these key messages – we highlighted the investments we are making
to drive the integration of Cxbladder into EMRs and online customer portals as
part of our effort to deliver an improved customer experience with seamless test
ordering and results delivery.
The sessions were enthusiastically received by the team, amid recognition
that they are better positioned than they ever have been to capitalize on the
opportunities our test offers.
PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2023
4

MEDICARE COVERAGE
A PERSUASIVE CASE – NOW TO THE VERDICT
1
The draft LCDs outsources coverage decisions to three knowledge bases to determine coverage, rather than the MAC. They are Clinical Genome Resource
(ClinGen); National Comprehensive Cancer Network (NCCN); Oncology Knowledge Base (OncoKB) knowledge bases.
Pacific Edge is confident we have made the
best possible legal and clinical arguments for
Cxbladder to retain Medicare coverage during the
open public meetings and the written comment
period for the draft Local Coverage Determination
(LCD) ‘Genetic testing for oncology’ (DL39365).
Our representations to Novitas were strongly
supported by the leading professional societies
in urology - the American Urological Association
(AUA), the Large Urology Group Practice
Association (LUGPA) and the American Association
of Clinical Urologists (AACU) – and by our industry
partners, the Coalition for 21st Century Medicine
(C21), the American Clinical Laboratory Association
(ACLA) and by many other key urologic opinion
leaders.
Together we highlighted the shortcomings
in the MAC’s evidentiary review to justify the
non-coverage decision and the sharp contrast
with its earlier reliance on the same evidence to
cover our tests. We also highlighted the flaws in
the conception of the LCD and particularly the
unprecedented approach of outsourcing Medicare
biomarker coverage decisions to three external
databases
1
.
We followed up these public submissions
with written comments to Novitas including a
point-by-point rebuttal of Novitas’ review of the
Cxbladder clinical evidence. Meanwhile a ‘who’s
who’ of US key opinion leaders in urology, including
numerous guidelines committee members, wrote an
independent editorial commenting on the impact of
Novitas’ approach. This editorial has been accepted
for publication in the journal “Bladder Cancer” and
covers the importance of urine biomarkers with
specific reference to Cxbladder and their optimal
usage in hematuria evaluation and recurrence
monitoring.
The submission period ended on 9 September
and now Novitas must consider and respond
publicly to all of the comments presented during
the notice and comment period.
Novitas has given no indication on when it
is likely to finalize the LCD, but it is statutorily
required to do so (or withdraw the LCD) within
365 days of the original publication date. An LCD
becomes effective 45 days after it is finalized.
The presentations given at the open meetings
and details of written submissions are available
on our website: https://www.pacificedgedx.com/
investors/presentations/
PAST AND FUTURE: PACIFIC EDGE’S MEDICARE JOURNEY
July ‘20
Novitas informs
Pacific Edge that
Cxbladder is
covered
July - Sep ‘22
Open Meetings,
Public Comment
Support from
industry, patient
advocates &
customers to retire/
revise DL39365
Jan ‘23
Triage gains coding
and then coverage
under LCA (A58917)
June - July ‘23
We pursue all
legal and political
strategies to overturn
the LCD
July - Sep ‘23
New draft LCD issued
(DL39365)
Notice and comment
period (ends 9 Sept)
Medicare coverage
continues
Novitas proposes
non-coverage for
Cxbladder with
LCD (DL39365)
Implementation
seen as unlikely
July ‘22
Contingency
planning for
adverse LCD
determination
amid expectation
of continued
coverage
Sep - May ‘23
Novitas finalizes
LCD (L39365) with
non-coverage for
Cxbladder, future
effective on 17 July
2 June ‘23
Novitas agrees to
follow procedure
for notice and
comment on the
LCD
LCD stayed,
Medicare coverage
continues
6 July ‘23
Date by which
Novitas must
finalize or
withdraw the

LCD
26 July ‘24
PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2023
5

KAISER PERMANENTE
A STRONG
SUPPORTER
Our arguments for continued Medicare
coverage of Cxbladder were significantly
bolstered by the release of unpublished non-
peer-reviewed data from Kaiser Permanente.
The real world evidence was documented in
a letter to Novitas from the AUA, LUGPA and
AACU and highlighted the role Cxbladder has
played in substantially reducing the number
of cystoscopies Kaiser undertakes each year.
Kaiser is the largest capitated system in the USA
covering more than 12.5 million lives.
The Kaiser data has also been submitted as
an abstract to the Society for Urologic Oncology
(SUO), and, if accepted, would form the basis
for a poster presentation of that evidence at the
SUO Meeting to be held between 28 November
and 1 December this year.
The data illustrates how Cxbladder Triage
safely excluded 78% of Kaiser patients
presenting with hematuria from a cystoscopy.
It also shows similarly positive results for
Cxbladder Monitor for Kaiser patients under
surveillance for the recurrence of bladder cancer.
Notably the study disclosed, for the first time,
that Kaiser undertakes approximately 25,000
cystoscopies each year in Southern California,
the first region in the Kaiser system to roll out
Cxbladder. While not all of these cystoscopies
are for hematuria evaluation or monitoring for
bladder cancer recurrence, the new Cxbladder
clinical pathways for Triage and Monitor are
expected to impact this number dramatically and
simultaneously drive down patient wait times.
In addition to supporting our Medicare case,
the study demonstrates the depth of support we
have earned from our years of partnership with
Kaiser and provides further detail regarding the
size of the initial Kaiser opportunity. We continue
to work with Kaiser to revise our commercial
agreement in regard to scaling the deployment
of Cxbladder through its Health Connect EMR,
in a model that is expected to link pricing to
volume.
DETECT
+

DETECT
+
CLEARS FIRST
COMMERCIALIZATION
HURDLE
Pacific Edge was notified in late September that
Detect
+
was included in the latest CPT coding
schedule release by the AMA with code 0420U.
Consequently, Pacific Edge has completed the
first of the three requirements for reimbursement:
coding, coverage and pricing. Our Market Access
Team will continue to work on pricing, targeting June
2024 for inclusion in the Clinical Lab Fee Schedule
potentially effective January 2025.
Concurrently, we will seek to obtain Medicare
coverage, but this timeline is dependent on the
quality of the clinical evidence to support the use
of the test. The groundbreaking Lotan et al (2023)
2
study delivered compelling evidence of the test’s
analytical validity. We are now looking forward to
the results of DRIVE, AUSSIE, microDRIVE and the
pooled analysis of these studies to deliver evidence
of clinical validity.
We expect our new CREDIBLE study (see page
8) to deliver evidence of the test’s clinical utility. We
will seek a coverage decision as we gain new clinical
validity or utility data.
2
Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations
Enhances Performance of Cxbladder Tests and Improves Patient Risk
Stratification. The Journal of Urology, 10-1097.
PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2023
6

CXBLADDER ECONOMICS
MAKING THE ECONOMIC CASE TO
HEALTHCARE INSTITUTIONS AND PAYERS
New health economic modelling shows routine
use of Cxbladder Detect offers healthcare
payers substantial savings for the evaluation and
treatment of patients presenting to clinicians with
hematuria.
A budget impact model for Cxbladder Detect,
developed by Pacific Edge and authors from the
Mayo Clinic and Germany’s Coreva using national
average data, has demonstrated median savings of
$521.94 in direct costs per patient annually.
“This study shows... that doing
the right thing for the patient
is also cost effective for the
health system payers.”

An abstract was submitted to the Western
Section of the American Urological Association
(WSAUA) conference and accepted as a poster
where it was presented in Lake Tahoe in early
October. It has also been submitted to the Society
for Urologic Oncology (SUO). A manuscript for
peer-reviewed publication has been submitted and
is under review.
The model compares the AUA guidelines as a
Standard of Care pathway to a Cxbladder clinical
pathway. Hematuria patients in the Standard
of Care pathway are stratified in line with AUA
guidelines based on clinical factors into low risk,
intermediate risk and high risk, while patients in the
Cxbladder clinical pathway are risk stratified into
AUA high risk (Detect positive) and AUA low risk
(Detect negative).
The authors noted this cost saving strengthens
the argument on the clinical value of deferring
or avoiding cystoscopies and imaging, sparing
thousands of patients these unnecessary
procedures.
“This study shows for the first time that doing
the right thing for the patient is also cost effective
for the health system payers,” says Pacific Edge
Senior Medical Director Daniel Shoskes, who is a
co-author of the study and Emeritus Professor of
Urology at the Cleveland Clinic.
“Furthermore, this model does not account
for indirect savings and other opportunities such
as decreased waiting time for appointments
and procedures, the cost and inconvenience for
patients of coming in for unnecessary visits, and
the environmental impact of eliminating the carbon
footprint and medical waste from unnecessary
medical procedures.”
We note the original abstract presented to the
WSAUA incorrectly states that the savings were
$1,524 per patient.
PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2023
7

PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2023
8
EVIDENCE GENERATION
CLINICAL STUDIES MARK NEW MILESTONES
New study ‘CREDIBLE’ commencing, microDRIVE
opens, STRATA analysis continues and DRIVE moves
closer to completion.
Pacific Edge is commencing a new study for
demonstrating the clinical utility of Cxbladder
Detect
+
in hematuria evaluation The study CREDIBLE
(Cystoscopic REDuction In BLadder Evaluations
for microhematuria) will follow at the conclusion of
our microDRIVE study. CREDIBLE is a randomized,
controlled study that will compare patients in the
control arm risk stratified by AUA Standard of Care
guidelines into high, intermediate and low risk with
patients in the test arm risk stratified by Cxbladder
Detect and managed as AUA high risk (Detect
+

positive) and AUA low risk (Detect
+
negative).
The clinical validation of Detect
+

is now also in full swing.

The primary endpoint for the study will compare
the number of cystoscopies between the test and
control arms. The number of tumors in each arm will
be collected and analyzed as part of the secondary
outcomes of the study.
The expectation is that the number of tumors would
not be significantly different between the test and
control arms, while the number of cystoscopies will
be significantly reduced in the test arm compared to
the control arm. We are targeting the completion of
CREDIBLE in mid 2026 with the goal of publication in
late 2026.
The clinical validation of Detect
+
is now also in
full swing with microDRIVE. We have completed
contracting, the Institutional Review Board (IRB)
has approved the study, and the first patients are
expected to be recruited within the next month. This
study is the first of its kind for Pacific Edge, as the
primary contracted VA site will enroll patients from
any VA site across the entire United States, acting in
a similar fashion to a contract research organization
(CRO) to dramatically reduce the total enrolment
time. The entire study will be supported digitally,
vastly improving our ability to monitor data quality,
perform interim analyses, final analyses and product
publications.
Meanwhile, since announcing the successful
conclusion of STRATA (Safe Testing of Risk for
AsymptomaTic MicrohematuriA) the data analysis
of the study is well underway. When concluded,
this analysis will determine if there is a statistically
significant difference in the proportion of patients that
receive a cystoscopy between the control arm (no
Cxbladder used) and the experimental arm (Cxbladder
Triage result used to inform cystoscopy) for patients
presenting with a mix of gross and microhematuria.
Pre-screen
from primary
care (MH and
no GH)
Endpoints
• Count of cytoscopies on each arm
• Count of tumors found on each arm or per scope
• Count of tumors at FU when no cytoscopy occurs on test arm
Control arm
Test arm
VISIT 1VISIT 2
Send to
Urology
Consent,

D+ urine
collection &
randomize
D+ Positive
SOC for
evaluation
Records review

(12 & 24 months)
Records review
(12 & 24 months)
Records review
(12 & 24 months)
Records review
(12 & 24 months)
Every 3mo for 1yr
(UA microscopy &
D+ home collection)
SOC for
evaluation
SOC for

evaluation
No scope

or visit
D+ Positive
D+ Negative
D+ Negative
CREDIBLE PROTOCOL
NOT REPORTED
REPORTED

EVIDENCE GENERATION
CLINICAL STUDY PROGRAM STATUS
STUDYGOALPOPULATION AND
USE
STATUS
STRATA
(Safe Testing of Risk
for AsymptomaTic
MicrohematuriA)
• CU for Triage
• CU for Detect
+

(retrospective)
• Microhematuria
• Risk stratification
- Enrolment is now closed with a total of
554 including 131 low risk patients Follow
up will continue until Q3 2024.
- Data monitoring is underway and
expected to be completed Q1 2024
DRIVE
(Detection and Risk
stratification In VEterans
presenting with
hematuria)
• CV for Detect
+

• CV for Triage and
within a Veterans’
cohort
• Data for pooled-
analysis
• Micro and gross
hematuria
• Risk stratification
- Enrolment total is 648 across 11 US sites
and in line with target
- Enrolment is expected to close late 2023
with follow up continuing until Q2 2024
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 August 2023 and
7 subjects are enrolled to date
microDRIVE
(Detection and Risk
stratification In VEterans
presenting with
hematuria)
• CV of Detect
+

• Data for pooled
analysis
• Microhematuria
• Detection
- Projected to start recruitment Oct 2023
as a network study across al VAMCs
coordinated from a single US VA site
- Target is 1000 patients and 50 tumor
confirmed
- Last patient in: March/April 2024
POOLED ANALYSIS• CV of Detect
+
• Microhematuria
• Risk stratification
- Microhematuria patients from DRIVE,
AUSSIE, STRATA and microDRIVE will be
pooled and performance determined
- The projected analysis is Q3-2025
LOBSTER
(LOngitudinal Bladder
cancer Study for
Tumor Recurrence)
• CV of Monitor/
Monitor
+
• Surveillance
• Risk stratification
- Target enrollment is 426 subjects across
10 sites (US, Australia)
- Enrolment is now 126 subjects
CREDIBLE
(Cystoscopic REDuction
In BLadder Evaluations
for microhematuria) - A
randomized, controlled,
clinical utility study for
hematuria evaluation
• CU of Detect
+
• Microhematuria
• Risk stratification
- Target enrollment is 1000 subjects with
an interim analysis at 600 to determine if
the primary objective has been addressed
- Due to commence late 2024
*Dates are calendar year not financial years
Clinical Utility (CU) - Evidence a test that can usefully change patient management within the context of care for
the defined population and indication.
Clinical Validity (CV) - Evidence a test works in the same way on an independent eligible population for a given
indication.
Analytical validity (AV) - Evidence a test is repeatable in the lab for a given indication and population.
Visit the Pacific Edge website to learn more about the strategic rationale for our studies.
PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2023
9

ABOUT US
Pacific Edge Limited (NZX/ASX: PEB) is a global cancer diagnostics company leading the way in the development
and commercialization of bladder cancer diagnostic and prognostic tests for patients presenting with hematuria
or surveillance of recurrent disease. Headquartered in Dunedin, New Zealand, the company provides its suite of
Cxbladder tests globally through its wholly owned, and CLIA certified, laboratories in New Zealand and the USA.
VISIT US ONLINE:
www.pacificedgedx.com
www.cxbladder.com
FOLLOW US ON SOCIAL MEDIA:
www.facebook.com/PacificEdgeLtd
www.facebook.com/Cxbladder
www.twitter.com/PacificEdgeLtd
www.twitter.com/Cxbladder
www.linkedin.com/company/pacific-edge-ltd
CONTACT US:
Centre for Innovation
87 St David Street
PO Box 56
Dunedin 9016, New Zealandd
T: +64 3 479 5800
E: investors@pacificedge.co.nz
INTERNATIONAL
CXBLADDER LIVE IN THE
PHILIPPINES
REGULATION
FDA SIGNALS LDT
REGULATION
The U.S. Food and Drug
Administration (FDA) has
released for public comment
proposed rule changes that seek
to have Laboratory Developed
Tests (LDTs) such as Cxbladder
regulated as medical devices
under the US Federal Food,
Drug, and Cosmetic Act.
There have been multiple
attempts by the FDA to regulate
LDTs over the last several
decades or to assert the narrative
that they have the right to do so,
but this is strongly opposed by
several major lobby groups, and
numerous legal challenges are
expected.
Pacific Edge continues to
invest in systems and processes
that will position the company
to comply with the FDA or any
other relevant regulatory body
to enable uninterrupted clinical
testing operations. Pacific Edge
intends to keep shareholders
updated about relevant
regulatory milestones related
to the FDA and other relevant
agencies and/or standards as we
achieve them.
Cxbladder is now live in the Philippines following the signing of a
distribution agreement with a local partner Hi-Precision Diagnostics
(HPD), one of the country’s largest medical laboratories, in June.
HPD’s sales team numbers more than 50+ people nationally and
the company has more than 70 sites across the country providing
strong exposure of Cxbladder to the 900+ urologists practicing in the
Philippines.
The agreement with HPD builds on similar agreements signed in
Latin America, Vietnam, and Israel. In each case, Pacific Edge initiates
logistical test shipments, works on any country specific registration
or market access requirements, translates marketing material with
our partners as necessary, and updates our billing processes. In all
cases, our Distribution Partners have exclusive sales and marketing
rights and are expected to drive the integration of Cxbladder into
local standards of care by leveraging their strong relationships with
clinicians and Pacific Edge’s peer-reviewed and published clinical
evidence.