Pacific Edge 2023 Annual Shareholder Meeting

27 July 2023
PACIFIC EDGE ANNUAL SHAREHOLDERS MEETING PRESENTATION
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) is today
holding its Annual Shareholders Meeting at LINK Market Services offices in Auckland, commencing at
10.00am.
It attaches presentations given by Chairman Chris Gallaher, Chief Executive Dr Peter Meintjes,
President Pacific Edge Diagnostics USA David Levison, and Chief Medical Officer Dr Tamer
Aboushwareb.
In the presentation Pacific Edge notes, it expects to manage cash reserves - in the event of an adverse
Medicare coverage decision - until it regains coverage, a process it would expect to take around 4
years.
Shareholders and other interested parties can also join the meeting online at:
www.virtualmeeting.co.nz/peb23
Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.
For more information:
Investors: Media:
Dr Peter Meintjes Richard Inder
Chief Executive The Project
Pacific Edge P: +64 21 645 643
P: 022 032 1263
OVERVIEW
Pacific Edge: www.pacificedgedx.com
Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way in the
development and commercialization of bladder cancer diagnostic and prognostic tests for patients
presenting with hematuria or surveillance of recurrent disease. Headquartered in Dunedin, New
Zealand, the company provides its suite of Cxbladder tests globally through its wholly owned, and CLIA
certified, laboratories in New Zealand and the USA.
Cxbladder: www.cxbladder.com
Cxbladder is a 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.

---

Pacific Edge
Annual Shareholders Meeting
Link Market Services
Auckland
27 July 2023
PacificEdge’sordinarysharestradeontheNZXand
theASXunderthetickercode:PEB

CHRIS GALLAHER
Chairman

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3

DIRECTORS
SARAH PARK
MARK GREEN
ANNA STOVE
TONY BARCLAY
BRYAN WILLIAMS
ANATOLE MASFEN

1.PRESENTATIONS
2.SHAREHOLDER DISCUSSION
3.RESOLUTIONS
4.ORDINARY BUSINESS
5.MEETING CLOSE
MEETING AGENDA

FY 23 HIGHLIGHTS: STRONG PERFORMANCE FOLLOWS STRATEGIC EXECUTION
1
Testing volume is measure by Total Laboratory (TLT) Throughput including commercial, pre-commercial and clinical studies testing
2
Unique ordering clinicians in Q4 23 vs Q4 22
3
Cash, cash equivalents and short-term deposits as at 31 March 2023
PACIFIC EDGE GLOBAL TEST VOLUMES
1
PACIFIC EDGE OPERATING REVENUE
$27.0M
NET LOSSAFTER
TAX
$77.8M
CASH, CASH
EQUIVALENTS
3
44%
US TEST
VOLUMES
1
(27,217 TESTS)
16,861
15,814
23,086
31,565
-
5,000
10,000
15,000
20,000
25,000
30,000
35,000
FY 20FY 21FY 22FY 23
TESTS
37%
$4,370
$7,701
$11,445
$19,616
$0
$2,500
$5,000
$7,500
$10,000
$12,500
$15,000
$17,500
$20,000
FY 20FY 21FY 22FY 23
$(000)
71%
46%
US ORDERING
CLINICIANS
2
(1,150 CLINCIANS)

PACIFIC EDGE’S MEDICARE JOURNEY
7
Novitas informs
Pacific Edge that
Cxbladder is
covered
July ‘20
Novitas proposes
non-coverage for
Cxbladder with LCD
(DL39365)
Implementation seen
as unlikely
July ‘22
Open Meetings, Public
Comment. Support from
industry, patient
advocates & customers
to retire/revise DL39365
July - Sep ‘22
Contingency planning
for adverse LCD
determination amid
expectation of
continued coverage
Sep - May ‘23
Triage gains coding
and then coverage
under LCA (A58917)
Jan ‘23
Novitas finalizes LCD
(L39365) with non-
coverage for
Cxbladder, future
effective on 17 July
2 June ‘23
We pursue all legal
and political
strategies to
overturn the LCD
June - July ‘23
Novitas agrees to
follow procedure for
notice and comment
on the LCD
LCD stayed, Medicare
coverage continues
6 July ‘23
Preparing for notice
and comment, open
meetings and medical
director meeting
Medicare coverage
continues
Strategy review
TODAY
Novitas is the Medicare Administrative Contactor (MAC)
with jurisdiction for Pacific Edge’s US laboratory.

8
PRESERVING CAPITAL AND CONTINUING TO CREATE SHAREHOLDER VALUE
COMMITTED TO MAINTAINING A STRONG BALANCE SHEET
•Pacific Edge expects to manage cash reserves - in the event of an
adverse Medicare coverage decision – until it regains coverage, a
process we would expect to take around 4 years.
STRATEGIC RESPONSE TO THE DETERMINATION
•Strategies:
•Legal challenges; alternative paths to coverage; an alternative
MAC; changed billing practices; other strategic options.
•Response so far:
•Continue to promote Cxbladder and process all tests ordered by
US clinicians with the current team
•Enhanced patient responsibility rolling out in stages from July 17
•Refocusing of evidence development, coverage and guidelines for
increased coverage certainty
DECISION CRITERIA
•Impact on revenue, expenditure and cash reserves, the time and
resources, the expected likelihood of success; and shareholder value.
Pacific Edge is continuing to review scenario planning, strategy and our risk management framework

Dr PETER MEINTJES
Chief Executive Officer

NOVITAS DETERMINATION IS A COMPANY DEFINING MOMENT
An unexpected, unprecedented and flawed decision
10
MEDICARE IS OUR LARGEST CUSTOMER
•Cxbladder has a majority Medicare and Medicare Advantage
population; average age of 73 for presentation with hematuria
•In FY23, Medicare and Medicare Advantage delivered ~13,800 tests
(~60%) of US commercial Cxbladder tests generating ~$15.3m in total
operating revenue (~77.3%)
NOVITAS SUMMARY CONCLUSIONS
Finalized LCD ‘Genetic Testing for Oncology’ (L39365) noted
Cxbladder tests ‘not considered medically reasonable and
necessary’, the threshold required for coverage under the US
Social Security Act, based on:
•Insufficient validation in confounding clinical
circumstances
•Population and gender biases
•High numbers of false positives
•Questions credibility of Pacific Edge funded research
•L39365 is focused on diagnostic, prognostic and predictive
tests following or as an adjunct to a confirmed
pathological diagnosis of cancer
Pacific Edge’s objections to the process leading up to the finalization of the
LCD and the LCD itself have received overwhelming support from industry
and the urological community.

11
NAVIGATING COVERAGE UNCERTAINTY
Clinical evidence development remains a priority
NOVITAS REPUBLISHES LCD
(Near future)
REVIEW AND COMMENT
(45-days)
NOVITAS DECISION
Novitas must withdraw or finalize LCD
within 365 days of publication.
Final LCD becomes effective (assuming
no further protest) 45 days after
finalization.
Cxbladderis well supported by the US urological community
with >1,200 separate clinicians (representing >10% of practicing
US urologists
1
) ordering >8,600 tests
2
in the US in Q1 24
4,277
4,706
4,591
5,290
6,073
6,699
6,629
7,816
8,627
657
690
741
789
895
978
1,082
1,150
1,232
-
100
200
300
400
500
600
700
800
900
1,000
1,100
1,200
1,300
-
2,000
4,000
6,000
8,000
10,000
12,000
Q1 22Q2 22Q3 22Q4 22Q1 23Q2 23Q3 23Q4 23Q1 24
US UNIQUE CLINICANS
US TEST VOLUMES
CLINICIANS (RHS)
1
American Urological Assn 2021 Census
2
Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing
LCD TIMELINE

8,147
6,864
11,136
14,920
8,714
8,950
11,950
16,645
-
5,000
10,000
15,000
20,000
25,000
30,000
35,000
FY20FY21FY22FY23
TESTS
2H
1H
6,573
5,591
9,192
12,422
7,054
7,385
10,004
14,269
-
5,000
10,000
15,000
20,000
25,000
30,000
FY20FY21FY22FY23
TESTS
2H
1H
19%
56%
25%
17%
61%
22%
DESPITE LCD UNCERTAINTY IN FY 23 WE DELIVERED STAND-OUT GROWTH
WE HAVE SHOWN ABILITY TO EXECUTE DESPITE CHALLENGING MARKET CONDITIONS
FY 22
TEST VOLUMES BY TYPE (TLT*)
GLOBAL COMMERCIAL TEST VOLUMES (TLT)
GLOBAL TEST VOLUMES (TLT)
FY 23 TOTAL LAB THROUGHPUT (TLT*)
•Global TLT increased 37% to 31,565 tests
•Global Commercial test volumes increased 39% to 26,691
•Global TLT is driven by US growth in the US (predominantly Detect)
•Hematuria evaluation (Triage & Detect) is the largest market
opportunity, ~3x the size of bladder cancer surveillance (Monitor)
23,086
15,814
16,861
*TLT is the Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing
FY 23
▲
39%
▲
37%
31,565
19,196
12,976
13,627
26,691
12

COVERAGE UNCERTAINTY HAS AFFIRMED OUR STRATEGY
CLINICAL EVIDENCE AND STRONG UROLOGICAL RELATIONSHIPS ARE FUNDAMENTAL TO SUCCESS
13

REFINING OUR FOCUS: ADOPTION, RETENTION AND REVENUE GENERATION
FOCUS AREAS:
1.NEW: Dimensioning the US business to reflect increased
probability of future adverse Medicare determination
I.National Accounts and Virtual Teams to support
Kaiser, VA, Capitated Systems
II.Enhanced Patient Responsibility with positive gross
margin per test
2.NEW: Expansion of APAC and Ex-US opportunities through
distribution agreements
3.Internal digitalization and Performance Excellence (PerfEx)
initiatives to improve the effectiveness and efficiency of our
operations
4.Marketing to amplify our clinical development program
within the urology and oncology communities with events,
sponsorship, communication and collateral
5.Empower patients through patient awareness and patient
advocacy initiatives through established societies and our
Cxbladder website
ADOPTION,
RETENTION AND
REVENUE
GENERATION
14

1,079
1,074
1,117
952
983
1,165
1139
1061
1079
-
200
400
600
800
1,000
1,200
Q1 22Q2 22Q3 22Q4 22Q1 23Q2 23Q3 23Q4 23Q1 24
TEST VOLUME
DRIVING GROWTH IN ASIA PACIFIC AND CONSOLIDATING NEW ZEALAND
APAC GENERATING ~14% OF TEST VOLUME
1
Commercial tests represent 83%of TLT in FY 23 for APAC
APAC TEST VOLUMES
1
1
FY 23 Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing
2
CAGR compares Q4 21 to Q4 23
NEW ZEALAND IS A MATURE MARKET
•Cxbladder is covered in 15 of the 20 new Te Whatu Ora, Health
New Zealand, representing >75% of the population
•Seeking national contract
AUSTRALIA & ASIA PACIFIC
•Australia and Southeast Asia still in business development
•New APAC President recruited in March 2023
•Transviet (Vietnam) and Hi-Precision (Philippines) distribution
agreements signed. Test shipments in progress
15

EVIDENCE, COVERAGE AND GUIDELINES: CHANGING CLINICAL PRACTICE
FOCUS AREAS:
1.Generate high-quality clinical validity and utility evidence
through clinical studies
2.NEW: Reconfigure evidence program to focus on:
I.Hematuria evaluation and surveillance (Detect
+
and
Monitor
+
)
II.The end points that matter most to guidelines
committees
3.Use Clinical Utility evidence to drive the adoption of Cxbladder
by clinicians, insurers and hospitals ahead of guideline inclusion
I.Pursue inclusion of Cxbladder in globally-relevant
standards and guidelines of clinical care across the
breadth of patient pathways
II.Foster trusted relationships with key opinion leaders,
relevant Urologic centers of excellence, professional
societies and patient advocacy networks to drive a
broader awareness and demand for Cxbladder
III.Develop the scientific and clinical credibility of the
Cxbladder brand
4.NEW: Consider merits of MolDX program
16

RESEARCH AND INNOVATION:
UNDERSTANDING THE ENTIRE COMMERCIALISATION PATHWAY
INTELLECTUAL
PROPERTY
TECHNOLOGYPRODUCT
COMMERCIALISATION
FOCUS AREAS:
1.NEW: Ensure R&D, Digital and Lab Operations focus on the launch of Detect
+
and Monitor
+
2.NEW: Working to ensure Cxbladder is ready for the anticipated US Food and Drug Administration (FDA) regulation of
laboratory developed tests (LDTs)
3.Evaluate ‘product concepts’ to address unmet clinical needs through market research and scientific/clinical advisory boards
4.Evaluate cutting-edge technologies to meet the market requirements of desired product concepts
5.Continue to build a patent portfolio for novel clinical applications of cutting-edge molecular technologies
6.Turn patented technology into clinically-validated molecular diagnostic tools that address an unmet clinical need
RESEARCH &
INNOVATION
17

18
ESG: PACIFIC EDGE IS FOUNDED ON IMPROVING SOCIAL OUTCOMES
GOVERNANCE
•Integrating oversight of Environmental, Social and Governance (ESG)
matters, including carbon reporting, into the Audit and Risk Committee
Charter
AOTEAROA NEW ZEALAND CLIMATE STANDARDS
•Measured carbon emissions (Scope 1, 2, 3) in FY 23 and positioned to
provide base year data in FY 24
•Working closely with Toitū Envirocare to accurately audit and measure
our greenhouse gas emissions, as we work towards achieving
certification in respect of FY 24
•Developing strategies and policies and evolving our risk management
framework to meet our reporting requirements.
ATTRACTING AND RETAINING TALENT AT PACIFIC EDGE
•We actively promote diversity, inclusion, engagement and fair
remuneration
Pacific Edge is delivering actionable informationthat can contribute to clinically meaningful improvements in cancer
treatment, improving lives, improving healthcare equity across populations and healthcare outcomes for patients
PROMOTING HEALTH CARE EQUITY
Following the introduction of Cxbladder into primary care in Te
Whatu Ora Canterbury, referrals to urologists were safely reduced,
urological waiting lists fell by 25%
1
1. Davidson, Peter; Presentation to Urofair, 2022, time to first specialist assessment.

OUTLOOK: FOCUSED ON FY24 EXECUTION
•Pacific Edge expects to manage cash reserves - in the event of an adverse
Medicare coverage decision - until it regains coverage, a process we would
expect to take around 4 years.
•We expect to re-focus the business on clinical development for guidelines
inclusion and increased coverage certainty for Detect
+
& Monitor
+
•Selling focus on clinical value as the driver of higher throughput/headcount
and throughput/clinician
•HEADWINDS:
•Possible non-coverage determination from Novitas on a new proposed
LCD after following appropriate procedure
•Possible negative physician or patient response to ‘balance billing’ on
commercial insurance
•CATALYSTS:
•Possible re-coverage determination from Novitas on new proposed
LCD after following appropriate procedure
•Kaiser EMR integration “go live” in Southern California
•Possible NCCN Guidelines inclusion after August submission
•Te WhatuOra national contract
•New clinician-generated CU evidence as studies completed
•We have world-leading technology, a strong balance sheet and we are
building momentum in the US and establishing footholds in new markets
19

DAVID LEVISON
President
Pacific Edge Diagnostics USA

PEDUSA –ADOPTION RETENTION AND REVENUE GENERATION
FOCUSED ON MEDICARE COVERAGE AND SELLING THE CLINCAL VALUE OF CXBLADDER
21
FOCUS AREAS:
1.NEW: Dimensioning the US business to reflect increased
probability of future adverse Medicare determination
I.National Accounts and Virtual Teams to support
Kaiser, VA, Capitated Systems
II.Enhanced Patient Responsibility with improved gross
margin per test
2.Internal digitalization and Performance Excellence (PerfEx)
initiatives continuing to improve the effectiveness and
efficiency of our operations
3.Amplify our clinical evidence generation program within the
urology and oncology communities with marketing,
sponsorship and our medical affairs teams
4.Empower patients through patient awareness and patient
advocacy initiatives through established societies and our
Cxbladder website
Pacific Edge’s offices and laboratory in Hershey,
Pennsylvania.

MONITOR FOR
RECURRENCE
SURVEILLANCE
(RDM
1
, TRM
2
, RECURRENCE)
PATIENT/DISEASE MANAGEMENT
(CLINICAL DECISION MAKING)
MOLECULAR DIAGNOSTICS VALUE CHAIN:
PATIENT JOURNEY
GENOMIC SCREENING
(PERSONALIZED GENETIC RISK)
ASYMPTOMATIC SCREENING
(EARLY DETECTION)
1.RDM: Residual Disease Monitoring
2.TRM: Therapeutic Response Monitoring.
22
INTENSIFY/DE-INTENSIFY
WORKUPS
SURGICAL OR
THERAPEUTIC
INTERVENTION
SYMPTOMS
ONSET
GENETIC RISK
AT BIRTH
DISEASE
MANIFESTS
ADJUDICATEDIAGNOSTIC
DILEMMAS

HEMATURIA EVALUATION AND SURVEILLANCE IN THE US MARKET
90%
Five-year survival
rate for NMIBC if
detected early
1
US$191K
Average lifetime
cost per patient
2
US$9.4B
Annual US spend on
bladder cancer
3
The US has >55m
men and >63m
women aged 50+
~7m
present with
hematuria
4
~3.4m
referred for
clinical
workup
7
>1.0m
patients
receive a
cystoscopy
5
~82k
Annual cases of
bladder cancer
6
~725k
patients living with
bladder cancer
~1.5Cxb Monitor/yr
6
US$3.5B
opportunity
7
(hematuria,
surveillance)
1. National Cancer Institute SEER.
2. Aly A et al. (2020) The Real-World Lifetime Economic Burden of Urothelial Carcinoma by Stage at Diagnosis. J Clin Pathw. 2020 May; 6(4):51-60
3. National Cancer Institute: Cancer Progress Trends Report
4. Journal of the American Medical Association
5. Kenigsberg, A, et al. The Economics of Cystoscopy: A Microcost Analysis, Urology 157: 29−34, 2021.
6. National Cancer Institute SEER.
7. Pacific Edge Estimate, opportunity estimated at US$760/Per test
VALUE PROPOSITION
Primary Care Physician
Urologist/Specialist
Patient care
pathway
Cxbladder
TRIAGE
Cxbladder
DETECT
Cxbladder
MONITOR
23
>4.5M TESTOPPORTUNITIES

24
HEALTH ECONOMICS –THE ECONOMIC VALUE OF CXBLADDER DETECT
AUA guidelines
recommend all high
and intermediate risk
microhematuria
patients receive a full
work up including a
cystoscopy & imaging
>1m cystoscopies are
needed to find 81,000
UC tumors, i.e. the vast
majority of
cystoscopies & imaging
are unnecessary
Used as a rule out test
- Detect could safely
reduce the number of
unnecessary
procedures
substantially
Pacific Edge modelling
suggests avoided
procedures could save
>US$1000 per patient
presenting with
microhematuria
ASSUMPTIONS
•US health expenditure on microhematuria evaluation using the 2020 AUA Guidelines vs CxbladderDetect test (sensitivity 82%, specificity 94% for UC).
•Detect test positive results proceeded with cystoscopy and imaging
•Detect test negativeresultswere re-evaluated for hematuria in 6 months.
•Performance of cystoscopy, CT Urogram and renal ultrasound were based on the published literature and the costs ofvisits and procedures from the Medicare
allowable fee schedule.
•Patients false positive (Cxbladder Detect or imaging) all had cystoscopy and allpositivecystoscopies led to Transurethral resection of bladder tumor (TURBT)
•Pacific Edge is working to publish this theoretical Budget Impact Model (BIM) over the coming months
Cxbladder Detect offers substantial total cost savings/patientwhen used to intensity or de-intensify
hematuria evaluation in patients presenting with microhematuria
1
1. Pacific Edge has developed a detailed budget impact model to understand costs to private practice, healthcare institutions and payers, over
and above the Cxbladder test price of $760/test focused on microhematuria patients

25
Distribution of Current
U.S. Customers
Pacific Edge Diagnostics
USA, Hershey,
Pennsylvania
Regional Sales
Director
Role: Manager
Target: Key clini-
cians and users
Focus: Escalation,
coordination
Account Executive
Role: Hunter
Targets: Urology
networks and
Urologists
Focus: Value
selling, ordering

National Account
Manager
Role: Strategic sale
Target: KOL's, large
institutions
Focus: Clinical
value, execution
Medical Science
Liaison
Role: Medical
Expert
Targets: KOLs
Focus: Clinical use
DIFFERENTIATED SALES ROLES FOCUSSED ON DIFFERENT CUSTOMER TYPES

26
REDIMENSIONING OUR SALES FORCE WITH STRATEGIC CHANGE
IMPACT ON TEST DEMAND AND REVENUE UNKNOWN
REVIEWING OUR APPROACH TO MARKET
•Focus on larger or value-based institutional accounts
•Sales initiatives focused on clinical value, economic value and
patient value
•Increase expectations of throughput per sales force headcount
•Amplify our clinical evidence generation program within the
urology and oncology communities with medical education
ENHANCED PATIENT RESPONSIBILITY AND SALE FORCES EFFICIENCY
•Patients with private insurance (non-Kaiser) to submit patient
responsibility notice
•Provides Pacific Edge with the means to collect payment
from the patient, as the patient acknowledges liability
•Patient Assist Program will offer customers discounts based on
income benchmarked against US federal policy guidelines
•Rolling out since mid-July, and expected to improve collections in
the event of insurer denial

1
Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing
2
CAGR compares Q4 21 to Q4 23
The Kaiser Health Plan covers >12.5m
members
•2 Kaiser sites in PEB’s Top 20
Accounts. 14 Kaiser sites across
Southern California ordering in FY23
•EMR software development and
integration testing complete; KP
and PE working towards “go live”
The US Veterans Administration
serves >9m veterans each year
•DRIVE study is a key
engagement with VA
urologists to determine
clinical validity in a cohort of
VA patients
27
ENHANCED CUSTOMER EXPERIENCE AND GROWING GLOBAL FOOTPRINT
DIGITALIZATION & CUSTOMER EXPERIENCE
•EMR integrations and Customer Portal
•Investment to upgrade older hardware and IT systems
•Performance Excellence: Lab Operations and Customer
Service
•Commercially-led product management for end-to-end
customer experience, supported by digital workflows
EX-US DISTRIBUTORS SUPPORTED BY PEDUSA
•ProGenetics (Israel) and SouthGenetics (LATAM)
distribution agreements
•Other geographies considered on a case-by-case basis
where appropriate distributors exist

1 RDM: Residual Disease Monitoring,
2. TRM: Therapeutic Response Monitoring
3. Lotan et al ‘Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratificationn
28
SIMPLIFYING THE CXBLADDER PROPOSITION –DETECT
+
AND MONITOR
+
LEVERAGING EVIDENCE SHOWING THE ADDITION OF DNA BIOMARKERS ENHANCES TEST PERFORMANCE

Dr Tamer Aboushwareb, MD, PhD
Chief Medical Officer
Pacific Edge Diagnostics USA

DRIVE EVIDENCE-BASED CLINICAL PRACTICE CHANGE AND MAINTAIN LEADERSHIP
FOCUS AREAS:
1.NEW: Reconfigure evidence program to focus on:
I.Hematuria evaluation (Detect
+
) and surveillance
(Monitor
+
)
II.The clinical end points that matter most to
guidelines committees
III.Specific patient populations relevant to clinical
utility
2.Use Clinical Utility evidence to drive the adoption of
Cxbladder by clinicians, insurers and hospitals ahead of
guideline inclusion.
3.NEW: Consider merits of MolDX program
30
FOCUS AREAS:
1.NEW: Ensure R&D, Digital and Lab Operations focus on
the launch of Detect
+
and Monitor
+
2.NEW: Working to ensure Cxbladder is ready for the
anticipated US Food and Drug Administration (FDA)
regulation of laboratory developed tests (LDTs)
RESEARCH &
INNOVATION

HOW CLINICAL EVIDENCE GENERATES SHAREHOLDER VALUE
CLINICAL EVIDENCE GENERATION IS A CORE ELEMENT OF OUR STRATEGY AND WILL CONTINUE TO BE
BEFORE GUIDELINE
INCLUSION
Clinical evidence drives early adoption
ofCxbladder and builds momentum for
guidelines inclusion
INCLUSION
AFTER
INCLUSION
Evidence strengthens the language
in guidelines supporting the use of
Cxbladder
REVIEW

CLINICAL EVIDENCE UNDERPINS COVERAGE AND GUIDELINES DECISIONS
Recognition in national guidelines is the best way to entrench Medicare coverage of Cxbladder and its use
and adoption by other independent contracted healthcare systems.
•Leading urologic authority in Europe and
globally influential
•Relevant standards of care: non-muscle
invasive bladder cancer
•Review period:with new evidence
•US-based not-for-profit alliance of 32
leading US cancer centres
•Relevant standards of care: High-risk
non-muscle-invasive bladder cancer
•Review period: annually
www.auanet.orgwww.nccn.orgwww.uroweb.org
•Globally the most influential and largest
urologicalassociation.
•Relevant standards of care: Hematuria,
microhematuria management and non-
muscle invasive bladder cancer (NMIBC).
•Review period: with new evidence
PACIFIC EDGE’S CLINICAL STUDY PROGRAM
microDRIVE
Detection and
RIsk Stratification
in VEterans
Presenting with
Microhematuria
POOLED
ANALYSIS
Pooled-analysisof
Detect
+
from
multiple studies
AUSSIE
Australian
Urologic risk
Stratification of
patientS wIth
hEmaturia
STRATA
Safe Testing of
Risk for
AsymptomaTic
MicrohematuriA
DRIVE
Detection and
RIsk Stratification
in VEterans
Presenting with
Hematuria
LOBSTER
LOngitudinal
Bladder Cancer
Study for Tumor
REcurRence

THE PRINCIPLES OF PACIFIC EDGE’S CLINICAL STUDY DESIGN PROGRAM
33
STUDYGOALUSE CASEPOPULATION
STRATA•CU for Triage
•CU for Detect
+
(retrospective)
•Risk stratification •Microhematuria
DRIVE•CV for Detect
+

•CV for Triage and within a
Veterans’ cohort
•Data for pooled-analysis
•Risk stratification •Microhematuria
and gross
hematuria
AUSSIE•CVof Detect
+
with an Australian
cohort
•Data for pooled analysis
•Risk stratification •Microhematuria
and gross
hematuria
microDRIVE•CV of Detect
+

•Data for pooled analysis
•Detection•Microhematuria
POOLED
ANALYSIS
•CV of Detect
+
•Risk stratification •Microhematuria
LOBSTER•CV of Monitor/Monitor
+
•Risk stratification •Surveillance
•Studies developing Clinical Validity (CV) evidence and
Utility (CU) in patients presenting with microhematuria
(the largest market).
•Inclusion of a population of gross hematuria in two
studies (AUSSIE, DRIVE) to simultaneously achieve CV
in gross hematuria patients, offering the prospect of a
different clinical utility pathway for these patients
•Multiple studies (three) to demonstrate CV of Detect
+

due to the low prevalence of cancer in microhematuria
patients (need a sample with a statistically significant
number of tumors).
•One large multicenter study for surveillance (LOBSTER)
•All studies offer endpoints supportive of NCCN and
AUA guideline inclusion
•Temporarily ceasing further investment in registries
and investigator-initiated trials
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
We will attempt to gain guideline inclusion (and coverage) with every new piece of clinical or economic
evidence, and through reframing our evidence with urology key opinion leaders

PROPOSED STUDIES FOR CLINICAL UTILITY OF DETECT
+
34
•US CU study-hem – will focus on producing clinical utility data for Detect
+
in microscopic hematuria patients (ABOVE)
•US CU-surveillance – will follow the CU for hematuria and focus on clinical utility of Monitor
+
NOT REPORTED
REPORTED

FIVE YEAR CXBLADDER CLINICAL STUDY ROAD MAP
35

FIVE YEAR CXBLADDER CLINICAL STUDY ROAD MAP (continued)...
36
*
*
*Proposed studies

INCREASING COVERAGE INDICATIONS WITH DETECT
+
AND MONITOR
+
TESTSUPPORTING EVIDENCE
Ongoing studies
-DRIVE
-AUSSIE
-microDRIVE
-Pooled analysis
Future studies
-RCT with pre-specified clinical pathway for the use of Detect
+

in micro-hematuria population
Completed studies
-Li K, Chu C, Patel M, Meng M, Morgan T, Porten S.Cxbladder
Monitor testing to reduce cystoscopy frequency in patients
with bladder cancer.Urol Oncol.2023
Ongoing studies
-LOBSTER
-RWE evidencesupportingthe utility ofCxbladderMonitor
Future studies
•RCT with pre-specified clinical pathway for the use of
Monitor
+
in surveillance population
FOCUSING RESOURCES DETECT
+
AND MONITOR
+
•HEMATURIA EVALUATION
•Detect and Triage tests to be superseded by Detect
+
as single
product for hematuria evaluation
•Clinical development resources directed to generating evidence
for Detect
+
•Every new publication on Detect
+
would necessitate a
reconsideration request and NCCN submission.
•SURVEILLANCE OF UC
•Monitor test to be superseded by Monitor
+
(inclusion of DNA
markers)
•Analytical validations and algorithm development already
underway with clinical samples collected for development of the
test.
•LOBSTER would develop the evidence for clinical validation
•A future multi-site Randomized Control Trial (RCT) would develop
the evidence for clinical utility
•Submission for coverage of Monitor
+
would happen with every
new publication

AMPLIFYING OUR EVIDENCE WITH UROLOGY OPINION LEADERS
CLINICAL DOSSIER DEVELOPMENT
•Contains all published Cxbladder data; externally reviewed
•Used to engage with guideline committees, private payors, government
payers, value-based clinician groups, ex-US distributors, etc.
•Annual NCCN submission of new evidence
PODIUMS, PRESENTATIONS, POSTERS AND PUBLICATIONS
•Increase “share of voice” by presenting data on Cxbladder utility in
multiple forums (AUA, SUO, ASCO GU), clinicians, academic institutions
•Publications – support for data generated and published by our users
and KOLs
•Speakers Bureau – trained, external KOLs and senior MSL team members
BUILDING KOL RELATIONSHIPS
•Academics, clinical leads in private practice, guidelines committees and
other influential clinicians
•Educational events, journal clubs, and resident training for large
institutions
38
VIDEO VIEWS
PUBLISHED
12/2/22
4102

RESEARCH & INNOVATION –FOCUSED ON COMMERCIALISATION
READYING FOR THE LAUNCH OF DETECT
+
AND MONITOR+
•Ensure R&D, Digital and Lab Operations focus on the launch of
Detect
+
and Monitor
+
•Develop higher level of documentation associated with
product development and analytical validation of our next
generation tests
•Continued engagement with industry and academic research
and development collaborations to address unmet clinical
needs in bladder cancer diagnosis and management
FDA REGULATION OF LABORATORY DEVELOPED TESTS (LDTs)
•FDA has stated they will regulate LDTs
•Tests like Cxbladder that are performed within a “single lab” as
a CLIA/LDT are expected to be included
•Announcement on regulatory path in August
39

CHRIS GALLAHER
Chairman
SHAREHOLDER QUESTIONS

APPENDIX

Mission
To help improve people’s lives and
patient outcomes by providing leading
solutions for the early detection and
management of cancer.
Vision
A world where the early diagnosis and
better treatment of cancer is within
reach of everyone.
“Nobody should die of cancer”
42

PACIFIC EDGE: RESEARCH, INNOVATION, COMMERCIALIZATION
2001
2001
Pacific Edge
established
2007
2007
Commercial
pivot to
focus on
urothelial
cancer
diagnostics
2008
Holyoake et al: Urine-
based RNA detection
of urothelial cancer.
Clin Cancer Res
2008
2011
2010
Pacific Edge
Diagnostics
New Zealand
(PEDNZ)
established
2012
2012
O’Sullivan et al:
Cxbladder Detect
performance
validation.
Journal of Urology
Dec 2012
Launch of Pacific Edge
Diagnostics USAand
Cxb Detect
2013
Mar 2013
PEDUSA receives
CLIA
accreditation
May 2013
First commercial
sale (Cxb Detect)
for PEDNZ
Mar 2013
First commercial
sale (Cxb Detect)
for PEDUSA
2014
Dec 2014
Launch of Cxbladder
Triage
2015
Mar 2015
Kavalieris et al:
Cxb Triage
performance
validation. BMC
Urology
Dec 2015
Launch of
Cxbladder
Monitor
2016
Nov 2016
Clinical trials
commence in
Singapore
2018
Feb 2018
Cxb Triage
adopted into
Canterbury
Community Health
Pathways with
primary care
referral
2019
Aug 2019
Konety et al: Clinical
Utility of Cxb Detect
in adjudicating
atypical cytology and
equivocal
cystoscopy.European
Urology
2020
Apr 2020
Patient in-home
sampling initiated in
the US
Jun 2020
Kaiser Permanente,
approves commercial
use of Cxbladder
Jul 2020
CMS confirms
reimbursement of
Cxbladderat
$760/test
2021
Aug 2021
Cxbladder reaches
70% public
healthcare
coverage in NZ
Oct 2021
PEB raises
$103.5m
(~US$72.5m)
Dec 2021
First commercial
sale of Cxbladder
in Australia
2003
Listed on
the NZX
Cxbladder
TRIAGE
Cxbladder
DETECT
Cxbladder
MONITOR
2022
Dec2022
Lotan et al:
Enhanced
Cxbladder
Tests Deliver
Improved
Performance.
Journal of
Urology
43

PACIFIC EDGE: OUR GLOBAL FOOTPRINT
44

CLINICAL EVIDENCE GENERATION TOWARDS GUIDELINE INCLUSION (1/2)
STUDYAIMLOCATIONSENROLLED
SITES*
STATUS**
STRATASafe Testing of Risk for AsymptomaTIc MicrohematuriA
Demonstrate the clinical utility (CU) of Cxbladder using a prospective, two-arm randomizeddesign to risk stratify
patients and rule out from cystoscopy
•Establish CU for CxbladderTriage in Micro Hematuria (MH) populations to identify patients at low risk of
bladder cancer that can safely avoid cystoscopy
•Retrospective analysis with Cxbladder Detect+ to show equivalent or greater CU in MH populations with the
improved performance characteristics
•CU evidence supports AUA/NCCN guidelines inclusion usingCxbladderTriage and/or CxbladderDetect+ to risk
stratify MH populations
USA
Canada
12 / 13-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
Prospectiverecruitmentof patients to a single-arm observational studytodemonstrate the Clinical Validity (CV) of
Cxbladder tests in risk stratifying Veterans presenting with hematuria
•CV evidence for Cxbladder Triage in MH and Gross Hematuria (GH) patients supplementing NZ Studies
•Demonstrate CV of Cxbladder Detect
+
within a Veterans cohort
•Retrospective analysis with Cxbladder Detect+ to demonstrate CV evidence supportingAUA/NCCN Guidelines
inclusion in MH & GH patients
•Contribute data to pooled-analysis to establish CV for Detect+ in MH patients
VA Sites (USA)11 / 11-Enrolment total is 601
-Target enrolment: ~600 patients
-Last patient in: Q3 2023
-Follow up: until Q2 2025
AUSSIEAustralian Urologic risk Stratification of patientS wIth hEmaturia
Prospectiverecruitmentof patients to a single-arm observationalstudyto demonstrateCV in an Australian
healthcare setting for patients presenting with MH and GH
•Demonstrate CVof CxbladderDetect
+
with an Australian cohort
•Demonstrate accurate risk stratification of hematuria patients to intensify or de-intensify evaluation
•Contribute data to pooled-analysis to establish CV for Detect+ in MH patients
Australia1 / 2-Target enrolment: 600 patients
-Enrolment due to start July 2023
*Estimated number of enrolled sites
**All dates are best-case estimates and subject to change
45

STUDYAIMLOCATIONSENROLLED
SITES*
STATUS**
Microhematuria
Pooled-analysis
Pooled-analysisof Cxbladder Detect+ performance from multiple studies involving prospectively recruited
patients from single-arm observational studies including eligible microhematuria patients
•CV of Cxbladder Detect
+
withMH patients
•Combines data from DRIVE, AUSSIE and a future MH-focused clinical trial
•Supports AUA/NCCN guidelines inclusion usingCxbladderDetect
+
to risk stratify MH populations
USA, AusN/A-DRIVE underway, AUSSIE and
microDRIVE projected to start in 2023
microDRIVE
Detection and RIsk Stratification in VEterans Presenting with Microhematuria
•Demonstrate the CV of Cxbladder Detect
+
in detecting urothelial cancer in patients presenting with
MH.
•MicroDRIVE will compare the performance of Cxbladder Detect
+
against the current gold-standard for
the detection of urothelial cancer, diagnostic cystoscopy and pathology.
USA0/1-Projected to start recruitment
Sep/Oct 2023
-Target is 1000 patients and 50
tumour confirmed
-Last patient in: March/April 2024
LOBSTERLOngitudinal Bladder Cancer Study for Tumor REcurRence
Prospectiverecruitmentof patients to a single-arm observational study to evaluate CV of Cxbladder
Monitor and Monitor
+
•To safely risk stratify patients under surveillance for recurrence of UC
•To demonstrate that it is safe to alternate Cxbladder Monitor and Monitor
+
with cystoscopy for
intermediate and high-risk patients under surveillance for recurrence of UC
•Targeting AUA/NCCN guidelines inclusion for biomarkers as an alternative to cystoscopy in a
surveillance setting
USA (including
some VA sites)
Australia
5 / 10-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
CLINICAL EVIDENCE GENERATION TOWARDS GUIDELINE INCLUSION (2/2)
*Estimated number of enrolled sites
**All dates are best-case estimates and subject to change
46

SUMMARY OF CLINICAL EVIDENCE
StudyPop.TypeSensitivity (Sn)NPVSpecificity (Sp)Comment
Detect+
AVLotan et al., 2022MH + GH*97%99.7%90%Pooled data from US and Singapore cohorts (n=804)
CV
DRIVE (unpublished) (1)MH + GH*Study in progress
AUSSIE (unpublished) (4)MH + GH*Study to start this year
microDRIVE (unpublished)
(5)
MH*Study to start this year
Triage
AVKavalieris et al., 2015MH + GH*95.10%98.50%45%Sn, Sp, NPV values when test-negative rate is 40%
CV
Davidson et al., 2019MH + GH*95.5% (1)98.6% (1)34.3%GH only: Sn (95.1%), NPV(98%), Sp(32.8%); MH only: Sn (100%), NPV (100%), Sp (42.6%)
Konety et al., 2019(2)100%
Cxbladder (3) correctly adjudicated all UC confirmed patients (n=26) with atypical urine cytology
results (n=153, 4)
Lotan et al., 2022MH + GH*89%99%63%Pooled data from US and Singapore cohorts (n=804)
CU
Davidson et al., 2020MH + GH*89.4% (5)98.9% (5)59% (5)
39% of patients testing negative for Cxb Triage & imaging did not get cystoscopy & were
managed at primary care (6)
STRATA (unpublished) (7)MH + GH*Study in progress
Detect
AVO'Sullivan et al., 2012GH*81.8%97%85.1%Cxb Detect detected 97% of HG tumors & 100% of Stage 1 or greater tumors.
CV
Lotan et al., 2022MH + GH*74%97%82%Pooled data from US and Singapore cohorts (n=804)
DRIVE (unpublished) (1)MH + GH*Study in progress
Monitor
AVKavalieris et al., 2017(1)88% (2)97% (2)N/A(3)
CVKonety et al., 2019(4)100%
Cxbladder (5) correctly adjudicated all UC confirmed patients (n=26) with atypical urine cytology
results (n=153, 6)
CUKoya et al., 2020(7)
Integration of Cxb Monitor into the surveillance schedule reduced annual cystoscopies (39%)
(8,9)
* Referred
MH: Microhematuria, GH: Gross Hematuria. For definitions of Sensitivity, NPV and Specificity please see the glossary on
page 61 of this presentation
47

FOOTNOTES FOR CLINICAL EVIDENCE SUMMARY
Footnotes
Detect+
1Observational study to validate performance characteristics and clinical utility of Cxbladder tests (Cxb Triage, Cxb Detect, CxbDetect
+
).
2Observational study to validate performance characteristics of Cxb Detect
+
in patients with UC of the upper tract.
3Patients with suspected upper tract UC (UTUC) or surveillance patients with a history of UTUC.
4Observational study to validate performance characteristics and clinical utility of Cxbladder tests (Cxb Triage, Cxb Detect, CxbDetect
+
).
5Observational study to validate performance characteristics of Cxb Detect
+
in microhematuria (MH) patients.
Triage
1Cxb Triage performance; Cxb Triage & imaging combined performance had a Snof 97.7% & NPVof 99.8%.
2Patients included hematuria evaluation (n=436) or surveillance previously diagnosed with UC (n=416) with both Cxbladder & urine cytology results.
3Cxbladder includes Cxbladder Triage & Cxbladder Monitor.
4This included n=70 for patients with hematuria & n=83 for patients with previously diagnosed UC and overall test negative rate of 30.7%.
5Cxb Triage performance; Cxb Triage & imaging combined performance had a Snof 98.1%,NPV of 99.9% & Spof 98.4%.
6Cxb Triage negative rate was 53%; Follow-up period of 21-months showed no missed cancers, demonstrating safety.
7The intent of STRATA is to show that it is safe to risk stratify low risk microhematuria patients and not undertake cystoscopy.
Detect
1
Observational study to validate performance characteristics and clinical utility of Cxbladder tests (Cxb Triage, Cxb Detect, CxbDetect
+
).
Monitor
1Surveillance patients previously diagnosed with primary or recurrent UC.
2Cxb Monitor performance characteristics on surveillance patients diagnosed with primary UC; Cxb Monitor had a Snof 93% and NPV of 94% on patients with recurrent UC.
3Using Kavalieris et al., (2017) data set, Lotan et al., (2017) compared relative performance of Cxb Monitor against NMP22 ELISA,NMP22 BladderChek and urine cytology.
4Patients included hematuria evaluation (n=436) or previously diagnosed UC (n=416) with both Cxbladder & urine cytology results.
5Cxbladder includes Cxbladder Triage & Cxbladder Monitor.
6This included n=70 for patients with hematuria & n=83 for patients with previously diagnosed UC; test negative rate of 30.7%.
7All patients were being evaluated for recurrence of UC (n=309 providing 443 samples).
8Cxb Monitor identified all seven confirmed recurrence events idnetified on the first cystoscopy.
9Patients returning negative Cxb Monitor results (n=235) had no pathology-confirmed recurrence at 1st cystoscopy
48

REFERENCES SUMMARY OF CLINICAL EVIDENCE
References
Detect+
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.
Triage
Davidson et al., (2019). 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,132(1497), 55-64.
Davidson et al., (2020). Assessment of a clinical pathway for investigation of haematuria that reduces the need for cystoscopy.The New Zealand Medical Journal (Online),133(1527), 71-82.
Kavalieris et al., (2015). A segregation index combining phenotypic (clinical characteristics) and genotypic (gene expression) biomarkers from a urine sample to triage out patients presenting with hematuria
who have a low probability of urothelial carcinoma.BMC urology,15(1), 1-12.
Konety et al., (2019). Evaluation of cxbladder and adjudication of atypical cytology and equivocal cystoscopy.European urology,76(2), 238-243.
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.
Detect
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.
O'Sullivan et al., (2012). A multigene urine test for the detection and stratification of bladder cancer in patients presenting with hematuria.The Journal of urology,188(3), 741-747.
Monitor
Kavalieris et al., (2017). Performance characteristics of a multigene urine biomarker test for monitoring for recurrent urothelial carcinoma in a multicenter study.The Journal of
Urology,197(6), 1419-1426.
Konety et al., (2019). Evaluation of cxbladder and adjudication of atypical cytology and equivocal cystoscopy.European urology,76(2), 238-243.
Koya et al., (2020). An evaluation of the real world use and clinical utility of the Cxbladder Monitor assay in the follow-up ofpatients previously treated for bladder cancer.BMC
urology,20(1), 1-9.
Lotan et al., (2017). Clinical comparison of noninvasive urine tests for ruling out recurrent urothelial carcinoma. Urologic Oncology: Seminars and Original Investigations, 35 (8), 531-539.
49

INDEPENDENT DIRECTORS
SARAH PARK
ANATOLE MASFEN
BRYAN WILLIAMS
ANNA STOVE
MARK GREEN
TONY BARCLAY
CHRIS GALLAHER
Chairman
Chris has held senior positions in
both CEO and CFO roles with large
international companies and was a
partner in Arthur Young, Chartered
Accountants. Prior to retiring from
full time corporate life, he was CFO
of Fulton Hogan, a large New
Zealand civil contractor.
DR PETER MEINTJES
Chief Executive Officer
Peter is a molecular diagnostics and
genomics leader focused on
nascent market development of
disruptive innovations to drive
commercial success. Prior to joining
Pacific Edge, he was based in
Boston in a succession of diagnostic
leadership roles. Most recently he
was the Chief Commercial Officer
at Eurofins Transplant Genomics
and before that CEO at Omixon.
SENIOR LEADERSHIP TEAM
GRANT GIBSON DAVID LEVISON DR TAMER ABOUSHWAREB
Chief Financial Officer President Pacific Edge USA Chief Medical Officer
GLEN COSTIN DARELL MORGAN DR JUSTIN HARVEY
President Asia Pacific Chief Operating Officer Chief Technology Officer
ANDY MCINTOSH
Chief Digital Officer
PACIFIC EDGE BOARD AND MANAGEMENT
50

GLOSSARY
•Sensitivity - the frequency with which a test correctly identifies patients with a disease.
•Specificity - the frequency with which a test correctly identifies patients without a disease.
•Negative Predictive Value (NPV) - the percentage of negative tests being true negatives (by standard of care).
•Positive Predictive Value (PPV) - the percentage of positive tests being true positives (by standard of care).
•Rule-out Rate (ROR) - the percentage of tests that return a negative result.
•Evidence definitions:
•Analytical validity: Evidence that a test is repeatable in the lab for a given indication and population.
•Clinical validity: Evidence a test works in the same way on an independent eligible population for a given indication.
•Clinical utility: Evidence that a test in the hands of a physician can usefully change patient management within the context of
care for the defined population and indication.
51

FOR MORE INFORMATION:
Dr. Peter Meintjes
Chief Executive Officer
email: peter.meintjes@pelnz.com
Grant Gibson
Chief Financial Officer
email: grant.gibson@pelnz.com
Pacific Edge
87 St David Street, PO Box 56, Dunedin, New Zealand
P +64 3 479 5800 F +64 3 479 5801
email: investors@pacificedge.co.nz
www.pacificedgedx.com
52