Quarterly Update – Q1 24 Test Volumes Reach New Heights

18 July 2023
Q1 24 INVESTOR UPDATE – TEST VOLUMES REACH NEW HEIGHTS
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) has today
released its Shareholder Update (attached) showing test volumes processed in its laboratories rising to
a new record in the first quarter of the 2024 financial year (Q1 24) of 9,706. The figure represents a 9%
rise on the 8,877 tests in the prior quarter (Q4 23).
The volume processed in Q1 24 also represents a 38% increase on the 7,056 tests processed in the
same quarter of the prior year (Q1 23). US volumes led the growth rising to 8,627 in Q1 24, a 10%
increase on the 7,816 tests in Q4 23. The figure also represents a 42% increase on the 6,073 tests
processed in Q1 23.
The continued growth in test volumes comes despite Novitas’
1
June 2023 release of the latest iteration
of the ‘Genetic Testing for Oncology’ Local Coverage Determination (LCD, L39365) and its subsequent
stay earlier this month. The still to be finalized LCD has the potential to end Medicare coverage of
Cxbladder in the US.
The number of unique ordering clinicians in the US has continued to grow through the quarter to 1,232
at the end of Q1 24, a figure that represents more than 10% of the 12,253
2
actively practicing urologists
in the US. The figure is, up 7% on the 1,150 ordering in Q4 23 and up 38% on the 895 clinicians who
ordered tests in Q1 23.
Asia Pacific volumes in Q1 24 were 1,079, up 2% on the 1,061 tests processed in Q4 23, and up 10%
on the 983 tests processed in Q1 23. The volume trends in APAC reflect the maturity of the New Zealand
market and the region’s ongoing healthcare reforms.
The update also details Pacific Edge’s success in gaining a stay on L39365, the strategic moves the
company has made since the publication of the LCD’s latest iteration and other important contextual
information for shareholders.
Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.
For more information:
Investors: Media:
Dr Peter Meintjes Richard Inder
Chief Executive The Project
Pacific Edge P: +64 21 645 643
P: 022 032 1263

OVERVIEW
Pacific Edge: www.pacificedgedx.com
Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way in the
development and commercialization of bladder cancer diagnostic and prognostic tests for patients
presenting with hematuria or surveillance of recurrent disease. Headquartered in Dunedin, New

1
Novitas is the Medicare Administrative Contractor with responsibility for Pacific Edge’s US laboratory.
2
American Urological Association 2022 census

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 is reimbursed by CMS and 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
Test volumes rise to a new record 3
Pursuing our political and legal options 4
Our clinical evidence 5
Enhancing patient payment responsibility 6
US Urologists rally in support of Cxbladder 6
Kaiser Permanente update 7
Communicating our path forward 7
Setting our sights on guideline inclusion 8
New distribution agreements signed 9
JULY 23

PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2023
2
Dear Shareholders,
I am pleased to announce
another record-breaking quarter in
laboratory testing throughput for
our Cxbladder products. I’m sure
it is not lost on shareholders that
this announcement comes on the
day (US time) that we would have
lost Medicare coverage, were it
not for the recent announcement
that Novitas
1
will not make Local
Coverage Determination (LCD)
L39365 effective on July 17, but will
republish with the opportunity for
open meetings and public comment.
This was the best possible result
that we could have expected from
our intense efforts since Novitas
announced it had finalized what
we and other commentators have
noted as a substantially flawed LCD
on 2 June 2023. Now, Pacific Edge
will have the opportunity to address
Novitas’ concerns and convey our
confidence that our primary clinical
evidence is sufficient to support
continued Medicare coverage of the
tests we currently have in the US
market.
Since the finalization of
the adverse LCD our focus in
conjunction with various partners
has been on pursuing a range
of actions aimed at retiring or
delaying its implementation on the
grounds that Novitas did not follow
statutorily regulated procedure. We
now appear to have prevailed on
these procedural matters.
Consequently, until we are
further advised, and until we have
concluded the notice and comment
period and a new LCD is finalized,
Pacific Edge expects to continue
to bill and receive reimbursement
for our tests from Medicare and
Medicare Advantage.
Pacific Edge will continue to
argue that the new approach in the
LCD to use third-party databases to
preemptively non-cover diagnostic
tests without evidentiary review
is unprecedented, not statutorily
supported and possibly unlawful.
However, we will focus more heavily
on the evidentiary review in the LCD
of Cxbladder products, rebutting
what our Medical Team and many
prominent Key Urology Opinion
Leaders perceive as a flawed
analysis that lacks understanding
of how to use our test and lacks
knowledge of the standard of care
in urology. We break down our
analysis of the evidentiary review for
investors on page 5.
“We now appear to
have prevailed on these
procedural matters.”

The events of the last few months
have prompted a thorough review of
our business operations in the event
of a non-coverage determination,
and this has already created
unanticipated value, including
important revisions to our strategy.
Starting today, and as flagged
earlier this month, we will ask our
patients to accept a greater degree
of financial responsibility for the
costs of performing a Cxbladder
test if an insurer denies us payment.
Pacific Edge will pass on a higher
patient responsibility to patients
with private insurance when that
insurer denies the claim. Patients
will be asked to sign a patient
responsibility notice that will include
our Patient Assist Program (see
page 6).
Regarding our clinical evidence
development, we announce today
that we have reached the primary
endpoint for the STRATA study,
so will cease enrolment, and begin
analysis, before deploying our clinical
evidence generation resources onto
other studies. Our high-level focus on
clinical evidence generation remains
the cornerstone of our long-term
strategy (see page 8).
Despite the LCD not becoming
effective on 17 July and its re-opening
for notice and comment, we
continue to work and develop the
strategies that we set out in June.
We have finalized and announced
the enhanced patient responsibility
program, acknowledging it will take
time to determine its efficacy.
We continue to explore
establishing a second lab in a
jurisdiction governed by the MolDx
Program to see if it would provide
greater certainty of retaining or
regaining Medicare coverage.
We are also exploring the
appropriate structure of the business
and what other strategic options are
available to the company that will
enhance shareholder value.
We aim to coalesce all of
our recent activities and update
shareholders on these workstreams
at our Annual Shareholders Meeting
to be held in Auckland and online on
Thursday 27 July 2023 (see page 7).
The event will include presentations
from our Chair Chris Gallaher,
Pacific Edge Diagnostics USA
President David Levison, our Chief
Medical Officer, Urologist Dr Tamer
Aboushwareb, and myself.
It will be an important event for
shareholders, and we encourage you
all to attend.
I look forward to seeing you there.
Ngā mihi nui,
Dr Peter Meintjes
Chief Executive
LETTER FROM THE CEO
CHARTING A NEW PATH
FORWARD
1
Novitas is the Medicare Administrative Contractor (MAC) with responsibility for our US laboratory.
2
The MolDX Program is a Medicare program that determines coverage, coding, and pricing of molecular pathology services.

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
1,079
Q3 21
3,110
943
Q2 21
2,791
1,088
Q1 21
2,133
852
35%
CAGR
35%
CAGR
-
200
400
600
800
1,000
1,200
1,400

Physicians
Q3 21
515
Q4 21
530
Q1 21
411
Q2 21
462
Q1 22
657
Q2 22
690
Q3 22
741
Q4 22
789
Q1 23
895
Q2 23
980
Q3 23
1,081
Q4 23
1,151
Q1 24
1,232
37%
CAGR
TOTAL TEST VOLUMES: GROUP
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2023
3
TEST VOLUMES
CONTINUED TEST VOLUME GROWTH
Test volumes processed at Pacific Edge laboratories rose to a new record in the first quarter of the 2024
financial year (Q1 24) rising to 9,706, a 9% rise on the 8,877
3
tests in the prior quarter (Q4 23).
The volume processed in Q1 24 represents a 38% increase on the 7,056 tests processed in the same quarter of the
prior year (Q1 23). US volumes led the growth rising to 8,627 in Q1 24, a 10% increase on the 7,816 tests in Q4 23. The
figure also represents a 42% increase on the 6,073 tests processed in Q1 23.
The continued growth in test volumes comes despite Novitas’ June 2023 release of the latest iteration of the
‘Genetic Testing for Oncology’ Local Coverage Determination and its subsequent stay earlier this month.
The number of unique ordering clinicians in the US has continued to grow through the quarter to 1,232 at the end
of Q1 24, a figure that represents more than 10% of the 12,253
4
actively practicing urologists in the US. The figure is
up 7% on the 1,150 ordering in Q4 23 and up 38% on the 895 clinicians who ordered tests in Q1 23.
Asia Pacific volumes in Q1 24 were 1,079, up 2% on the 1,061 tests processed in Q4 23, and up 10% on the 983
tests processed in Q1 23. The volume trends in APAC reflect the maturity of the New Zealand market and the
region’s ongoing healthcare reforms.
3
Historic test throughput numbers may vary slightly from those reported in prior quarters due to data recording inconsistencies determined by ongoing data
provenance initiatives.
4
American Urological Association 2022 census.

LCD CHALLENGE
EXPLORING ALL LEGAL AND POLITICAL PATHS
With the finalization of the Novitas ‘Genetic Testing for Oncology’ (L39365) LCD in early June, we
launched a concerted legal and political campaign aimed at retiring or delaying its implementation.
Firstly, through our industry partners we have
initiated lobbying efforts to engage with our local
(Pennsylvania) Congressmen and Senators to
reach the White House and the Department of
Health and Human Services (HHS) that oversees
the Medicare Program.
Our goal here is to highlight for those political
leaders the significant consequences for:
• Medicare patients who will have lost access
to our tests;
• Physicians who will have lost the ability to
choose our tests for their patients; and
• The Medicare Program, which will not
realize the clinical and potential economic
benefits of modern non-invasive biomarker
tests that improve the standard of care by
reducing unnecessary invasive diagnostic
procedures.
5

Secondly and coordinated in parallel, we
have made procedural arguments through our
US attorneys to the HHS Office of the General
Counsel (OGC), which has the power to direct
Medicare to retire or delay the Novitas LCD. Our
focus has been on highlighting several procedural
anomalies in the finalized LCD:
• We were denied ‘notice and comment’ on
a new unpublished evidentiary review in
the LCD;
• The LCD continues to rely on third-party
databases
6
, which have no statutory role
in coverage determination, when MACs are
statutorily required to determine coverage;
and
• We had non-commercial products reviewed
without requesting consideration;
Novitas now appears to have acknowledged
‘notice and comment’ argument while remaining
silent on the other matters.
Thirdly, we have sent official requests to
Novitas for meetings from our executives and our
Medical Affairs Team to discuss the substantial
misunderstandings about our peer-reviewed and
published clinical evidence.
We have earnestly stressed that we would like
5
Davidson, Peter. Presentation to Urofair Urofair 2022 Lunch Symposium: Advances in Bladder Cancer Diagnostics | Cxbladder - YouTube 2022
6
The finalized LCD relies on three knowledge bases to determine coverage. They are Clinical Genome Resource (ClinGen); National Comprehensive Cancer
Network (NCCN); Oncology Knowledge Base (OncoKB) knowledge bases.
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2023
4

REBUTTING NOVITAS’ CRITIQUE
Pacific Edge and Novitas have conflicting views in several
key areas related to our primary evidence.
NOVITAS SAYS: Populations of patients in Pacific Edge
trials that were tested included a strong bias towards male
patients of European ancestry and were not vetted in the
context of Medicare patients.
WE SAY: Novitas appears not to understand the basic
demographics of bladder cancer. Males are three times
more likely than women to present with the disease,
patients with European ancestry also have higher
incidence when compared with other ethnicities and these
demographics are therefore present in greater numbers
in our clinical trials. Our evidence is relevant to Medicare
patients since the average age of bladder cancer patients
is over 70 and Medicare eligibility is for patients over the
age of 65.
NOVITAS SAYS: Cxbladder delivers a high number of
false positive results, and this leads to patient anxiety and
distress.
WE SAY: Novitas appears to misunderstand how
Cxbladder is used by clinicians. Cxbladder’s proposition
relies on its high Negative Predictive Value (NPV) i.e., a
negative result allows urologists to reduce unnecessary
tests and procedures confidently and safely in patients at
a low risk of having bladder cancer but are required to be
investigated by the current standard of care. In the event
of a positive Cxbladder result, clinicians should continue
the evaluation of the patient for any other cause of disease,
including upper urinary tract assessment.
NOVITAS SAYS: A good test should differentiate between
urothelial carcinoma vs other types of urinary tract cancers.
WE SAY: Cxbladder is not a multi cancer assay and
we never claimed or attempted for it to fulfill this role.
The goal of our test is only to identify the probability
of presence or absence of a single cancer (urothelial
carcinoma) to improve the standard of care for hematuria
evaluation and/or surveillance for recurrent disease.
NOVITAS SAYS: Pacific Edge studies have a short follow up
period.
WE SAY: Our tests provide a snapshot in time assessment
of patients and are neither prognostic nor predictive tests.
Follow up period is irrelevant for point in time diagnostics.
NOVITAS SAYS: Pacific Edge did not recruit patients with
inflammatory conditions to assess the use of our products
in those patients.
WE SAY: We have excluded all those patients from clinical
and commercial use of Cxbladder as we already know
those patients are not the right target for our tests.
NOVITAS SAYS: Pacific Edge’s authoring and funding of
the primary literature for Cxbladder is a concern.
WE SAY: It is the industry norm for studies demonstrating
the analytical validation, clinical validation, and clinical
utility of biomarkers, medical devices, and pharmaceuticals
to be funded by those who develop those innovations.
to find a mutually agreeable solution
that is based on scientific and
clinical evidence. We expect to have
the opportunity to comment in line
with their statutory obligations of 45
days, but this meeting has not yet
been held, or scheduled.

Novitas now appears to
have acknowledged
‘notice and comment’
argument while remaining
silent on the other
matters.
Should L39365 ultimately
confirm an unfavorable result for
Pacific Edge, additional options are
available. Pacific Edge can initiate
a Medicare appeals process on
behalf of an ‘aggrieved beneficiary’
– a patient who has been denied
coverage on the basis of this LCD
– who will have standing to initiate
that process.
Pacific Edge has two paths here,
firstly to appeal claim-by-claim
through up to five levels of appeal
starting with Redetermination (level
1), Reconsideration (level 2) and
a Medicare Hearing in front of an
Administrative Law Judge (ALJ,
level 3 – which has the authority
to overturn an LCD), but secondly
to directly challenge the validity
of the LCD in a Medicare Hearing.
Our lawyers, our Medical Affairs
Team and our Market Access Team
are already prepared with the
arguments.
While we are hopeful of success,
it is a lengthy process and there
is no certainty that we will prevail.
In the meantime, we will continue
to generate clinical evidence for
our products, intended to achieve
coverage and guidelines inclusion.
LCD CHALLENGE CONT.
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2023
5

LCD INDUSTRY RESPONSE
US UROLOGICAL COMMUNITY PUSHES BACK ON NOVITAS LCD
While Pacific Edge has been a leading industry
voice, the broader community has rallied together
and called for the reconsideration of the ‘Genetic
Testing for Oncology’ LCD. Without exception
they share our concerns and are joining with us to
advocate for change. These representations will
be critical as we look to the next steps of ensuring
Cxbladder remains a covered test for the Medicare
population.
Key actions that support our calls include:
• Prominent members of the American Urological
Association (AUA), are preparing an Op-Ed for
publication in the prestigious AUA Journal of
Urology that should be published in the coming
weeks highlighting the value of biomarkers in
the diagnosis and treatment of bladder cancer
that would be eliminated by Novitas’ approach.
• Industry groups including The American Clinical
Laboratory Association (ACLA), The Large
Urology Group Practice Association (LUGPA),
the Coalition for 21st Century Medicine (C21)
have written to and/or are planning to write to
Novitas (and its sister MAC First Coast Service
Options) during the re-opened comment period
asking them to retire or delay the LCD and have
joined with Pacific Edge and others to work for
change.
We cannot be sure any of these efforts will deliver
the outcomes we seek. However, collectively they
demonstrate the sentiment and the resolve with
which we must continue in the face of Novitas
restarting the review process.
MAXIMIZING REIMBURSEMENT
ENHANCING PATIENT PAYMENT RESPONSIBILITY
Pacific Edge has made changes to its billing policy
that takes effect on July 17, 2023, but given the
ongoing Medicare coverage, this will now look slightly
different from what we announced to the market a few
weeks ago.
Only tests received from patients with private
insurance (except those such as Kaiser with whom we
have contracted coverage) will need to submit a patient
responsibility notice, and not an ABN (required for
Medicare). If a patient’s insurance company declines to
cover the test, the patient responsibility notice provides
Pacific Edge with greater means to collect payment
from the patient, as they have already acknowledged
this personal liability. Our Patient Assist Program will
continue to offer discounts to customers based on their
income benchmarked to the Federal Poverty Guidelines,
but the patient responsibility will be increased in all
cases.
The move is part of a broad range of actions that
Pacific Edge is pursuing to ensure it conserves capital
as it seeks to retain Medicare coverage of Cxbladder,
while still giving patients and clinicians access to the
valuable and actionable information our tests offer.
We are uncertain of the extent to which this new
approach will impact demand for our test in the US,
but we expect it to improve collections in the event
of a denial from any non-contracted insurer and
make some contribution to to revenues, thus improving
the overall average selling price for commercial testing.
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2023
6
Pacific Edge is incredibly grateful for the over-whelming support we have received from the US urological
community and diagnostic testing industry.

NATIONAL ACCOUNTS
KAISER EMR
PROGRESS
2023 ASM
A PATH FOR INCREASING COVERAGE CERTAINTY
We will of course review the 2023 financial year and
our significant success over that period. But in addition
to this, Chairman Chris Gallaher, Chief Executive
Dr Peter Meintjes, President of our US business
David Levison, and Chief Medical Officer Dr Tamer
Aboushwareb will discuss our approach to retaining
Medicare coverage for Cxbladder and commercialize
our tests in the US and around the world. We will also
detail the changes we are making at the business to
achieve these goals.
The team will also be available to take your
questions. We strongly encourage shareholders and
all other people interested in Pacific Edge to attend in
person or to join the meeting virtually via the online
meeting platform provided by our share registrar Link
Market Services.
Details of the meeting, the agenda and how to
participate virtually were included in the formal
Notice of Meeting sent to shareholders in late June
and are detailed below. However, should you have any
questions you should contact Link Market Services.
Where: Link Market Services Board Room
Level 30, PwC Tower
15 Customs Street West, Auckland 1010
When: 10.00am 27 July 2023
Notice of Meeting:
https://www.pacificedgedx.com/news-and-events/
news/2023/notice-of-annual-shareholders-meeting/
Connect virtually: www.virtualmeeting.co.nz/peb23
Virtual ASM assistance:
https://bcast.linkinvestorservices.co.nz/generic/docs/
OnlinePortalGuide.pdf
https://www.linkmarketservices.co.nz/
To help us plan for catering and seating at the event
Pacific Edge would appreciate you signaling your
intention to attend by providing an RSVP through the
following Eventbrite link: https://bit.ly/PEB-ASM2023
Please note that you do not need to RSVP to attend
the Annual Shareholders Meeting.
Pacific Edge and Kaiser Permanente
continue to work cooperatively
towards the ‘go live’ of Cxbladder’s
integration with Kaiser’s Electronic
Medical Records (EMR) system.
Kaiser, like other private
healthcare providers in the US, makes
independent medical policy decisions
based on their own evaluations, their
own clinical evidence, and their own
determination of economic value.
Kaiser’s usage of Cxbladder testing
continues to increase on a consistent
basis, and we look forward to moving
through implementation and onto
logistical considerations in the near
future.
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2023
7
At our Annual Shareholders Meeting in Auckland on 27 July 2023, we intend to provide a consolidation
of all initiatives in our strategic response to Novitas’ adverse ‘Genetic Testing for Oncology’ LCD and
the future possibility of non-coverage.

CLINICAL EVIDENCE
STRATA SUCCESSFULLY CONCLUDING AS
PRIMARY ENDPOINT ACHIEVED
With the consolidation of the Medical Affairs Team, we have reconfigured our evidence generation program
to focus on the endpoints that matter most to the clinical guidelines committees of the American Urological
Association and the National Comprehensive Cancer Network. With this in mind, we are bringing STRATA (Safe
Testing of Risk for AsymptomaTic MicrohematuriA) to a successful conclusion.
Based on the power calculations for the primary endpoint, the study has enrolled the planned number of
patients in the randomized part of the study to initiate our statistical analysis plan. When concluded, this analysis
will determine if there is a statistically significant difference in the percentage of patients that receive a cystoscopy
between the control arm (no Cxbladder used) and the experimental arm (Cxbladder Triage result used to inform
cystoscopy). The precise performance characteristics of the study, the safety data, the follow up and the data
analysis will continue, while the study has ceased enrolment effective in early July.
The clinical development program remains the most important driver of strategic value for Pacific Edge, and
consequently, we will continue to invest resources to accelerate microDRIVE, DRIVE and AUSSIE for the earliest
possible completion dates. Combining these remaining studies in a pooled analysis is expected to deliver clinical
validation evidence on microhematuria and gross hematuria populations needed by guidelines committees to
establish a recommendation for Cxbladder Detect
+
as safe for the purposes of ruling out cystoscopy in those patient
populations. Further updates to our clinical development program to accelerate our path to regaining coverage will
be announced as and when appropriate.
STUDY ENROLLED SITES*
AND LOCATIONS
STATUS**
STRATA
(Safe Testing of Risk for AsymptomaTic
MicrohematuriA)
12/13
USA/Canada
- Enrolment total is 545
- Target enrolment: 600 patients, including
120 low risk subjects (now 131)
- Last patient in: Q3 2023
- Data monitoring underway and expected
to be completed Q1 2024
- Follow up: until Q3 2024
DRIVE
(Detection and Risk Stratification in
Veterans Presenting with Hematuria)
11/11
VA Sites (USA)
- Enrolment total is 601
- Target enrolment: ~600 patients
- Last patient in: Q3 2023
- Follow up: until Q2 2025
AUSSIE
(Australian Urologic risk Stratification of
patients with hematuria)
1/2
Australia
- Target enrolment: 600 patients
- Enrolment due to start July 2023
Microhematuria Pooled-analysis
Pooled-analysis of Cxbladder Detect
+

performance from multiple studies involving
prospectively recruited patients from single-
arm observational studies including eligible
microhematuria patients
N /A
USA/Australia
- DRIVE underway, AUSSIE and microDRIVE
projected to start in 2023
microDRIVE
(Detection and Risk Stratification in
Veterans Presenting with microhematuria)
0/1
USA
- Projected to start recruitment Sep/Oct 2023
- Target is 1000 patients and 50 tumour
confirmed
- Last patient in: March/April 2024
LOBSTER
(Longitudinal Bladder Cancer Study for
Tumor Recurrence)
5/10
USA (including some
VA sites)/Australia
- Enrolment is now 100 patients with
157 samples collected to date
- Each site will enroll 100 patients within 12
months and follow up for another 12 months
Please note that dates are calendar years not financial years. For definitions of Analytical Validity (AV), Clinical Validity (CV), and
Clinical Utility (CU) please refer to www.pacificedgedx.com
*Estimated number of enrolled sites **All dates are best-case estimates and subject to change
Visit the Pacific Edge website to learn more about the strategic rationale for our studies.
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2023
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: +64 3 479 5800
E: investors@pacificedge.co.nz
INTERNATIONAL MARKETS
DISTRIBUTION AGREEMENTS
IN APAC AND LATIN AMERICA
As we continue to grow our international business,
Pacific Edge Diagnostics New Zealand have signed
two new Cxbladder distribution agreements in the
APAC Region, this time with Transviet Service and
Trading Company Limited in Vietnam and Hi-Precision
Diagnostics in the Philippines.
Following on from establishing Ex-US distribution
with ProGenetics in Israel, Pacific Edge Diagnostics
USA have added a second Distribution Partner,
SouthGenetics, for distribution of Cxbladder tests in
three Latin American countries, Argentina, Uruguay,
and Venezuela after the education presentations to
physicians and distribution partners in those regions at
the recent AUA Meeting.
As we bring on these new partners, 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. Training
is also key to successful distribution partnerships and
is already underway or scheduled with all partners.
Simultaneously, we are working to activate these
distribution agreements commercially and we have seen
the first signs of traction with initial tests ordered from
Israel, and in the APAC markets we serve directly, like
Singapore.
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.
HO CHI MINH CITY