Novitas finalizes non-coverage determination

13 January 2025


NOVITAS FINALIZES NON-COVERAGE DETERMINATION
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today
notes that Novitas, the Medicare Administrative Contractor with jurisdiction for our US
laboratory, on Thursday 9 January 2025 finalized a non-coverage determination that would
end reimbursement for Cxbladder Triage, Detect and Monitor by Medicare.
The draft Local Coverage Determination (LCD) ‘Genetic testing for oncology’ (DL39365) has
been finalized under a new title ‘Genetic Testing in Oncology: Specific Tests’ (L39365). The
LCD reverses Novitas’ July 2020 determination
1
that provided for Medicare coverage of
Cxbladder. If not challenged, the finalized LCD would become effective in 45 days from the
date of publishing, with reimbursement of Pacific Edge’s Cxbladder tests Triage, Detect and
Monitor ceasing on 23 February 2025.
The new ‘Genetic Testing in Oncology: Specific Tests’ (L39365), acknowledges some
shortcomings of the original draft LCD (DL39365), but remains flawed, particularly in its review
of the clinical evidence underpinning Cxbladder tests.
Specifically, Novitas:
- Continues to misunderstand the current standard of care in evaluating hematuria
patients, and the important role that biomarkers can play in stratifying patients with
hematuria into those that would benefit from further potentially more invasive medical
attention and those that would not.
- Fails to consider new peer reviewed evidence supporting the use of Cxbladder
published since the revised draft determination in July 2023, despite having been
notified of the evidence and stating in writing that it would incorporate that evidence in
the review. Specifically, Novitas has not reviewed or cited:
o the ground-breaking STRATA
2
randomized control study published in July
2024, which demonstrated the Clinical Utility (CU) of Cxbladder Triage and
importantly that this study showed that clinicians undertook 59% fewer
cystoscopies, when provided with a Triage test result; and
o the analytical validation data of Cxbladder Detect, Triage and Monitor published
in September 2024
3
.

1
Pacific Edge was informed by Novitas that its tests were covered in July 2020 (A58529)
2
Lotan et al (2024). A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder
Triage to Cystoscopy in Patients With Microhematuria. The Safe Testing of Risk for Asymptomatic
Microhematuria Trial. J Urol 2024.
3
Harvey et al (2024) Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for
Detection and Management of Urothelial Carcinoma. Diagnostics. 2024; 14(18):2061.

- Repeats its flawed analysis of the existing clinical evidence for Cxbladder tests by
focusing on the biomarker discovery study by Holyoake et al in 2008
4
and creates
confounded conclusions by lumping the evidence in future publications from all assays
together and not the clinical evidence supporting the individual products.
Pacific Edge Chairman Chris Gallaher said: “We are disappointed by Novitas’ determination,
which has been made despite strong representations from Pacific Edge, many key opinion
leaders in urology, bladder cancer patient advocates and the molecular diagnostics industry.
“Nevertheless, it is an outcome for which Pacific Edge has prepared. Following the release of
the draft determination (DL39365) in late July 2023, and in recognition of the elevated risk of a
decision such as this, we restructured our business to reduce our cash burn.
“With the LCD finalized, we are now activating the contingency plans and strategies to further
reduce our expense base until we regain reliable Medicare coverage. With $28.5 million in
reserves as at the end of December 2024, the company the company is well placed to fund
the re-coverage process if necessary and regain reimbursement for our tests,” Mr Gallaher
said.
Pacific Edge Chief Executive Dr Peter Meintjes said: “We are disappointed by a finalized LCD
that misunderstands the science of biomarker discovery and diagnostic test development in
the context of the standard of care in urology. We are do not understand its framing of
Cxbladder as a screening test of asymptomatic patients and at the failure to acknowledge the
views of the American Urological Association (AUA) and the practicing clinicians that derive
value from the test.
“Furthermore, we cannot believe that Novitas would commit in writing to review our most recent
evidence (the STRATA study and recent analytical validation data) as part of developing this
LCD and then fail to do so. Ignoring a randomized controlled trial (classified as Level 1
Evidence) published during the lengthy deliberations on the LCD and the consensus of the
urology community runs counter to the mandate of a US government health insurance
program, Dr Meintjes said.
“Regardless, we are prepared to continue to do what is best for our investors, physicians and
patients.”
Dr Meintjes said the go-forward plans may include the following:
• Pursuing a preliminary injunction and legal challenge to the finalization of the LCD.
Pacific Edge notes and recognizes the inherent uncertainty of success in these
endeavors.

4
Holyoake et al (2008) Development of a multiplex RNA urine test for the detection and stratification of
transitional cell carcinoma of the bladder. Clin Cancer Res 2008;14:742–9.

• Further review the structure of our operations and our strategy to reduce cash burn in
line with our plan to regain reliable Medicare coverage.
• Submit to Novitas a Medicare coverage reconsideration request on the basis of the
Journal of Urology’s publication of the STRATA study and the updated Analytical
Validation studies of Triage, Detect and Monitor.
• Continue to explore other strategic alternatives for Pacific Edge that could support the
company through to regaining reliable Medicare coverage and advancing the
commercialization of Cxbladder globally.
Dr Meintjes emphasized that the long-term focus of the company remains unchanged and that
the team is looking forward to the outcome of the AUA’s ongoing review of its microhematuria
guideline following the publication of the STRATA study. The possibility of AUA Guidelines
inclusion creates additional potential for a reconsideration request for Medicare coverage to
Novitas.
Pacific Edge is currently unable to fully determine the impact of the new LCD on test volumes
in the US market for the remainder of the 2025 financial year and beyond, but in 1H 25
Medicare and Medicare Advantage delivered ~5,300 commercial tests (~54% of US
commercial tests) and ~$6.5m NZD in total operating revenue.
The company expects to continue to bill and receive reimbursement from contracted US payers
without interruption, notably Kaiser Permanente and the US Veterans Administration, and from
non-contracted private payers in line with historic reimbursement rates. Similarly, Pacific Edge
expects collections from the enhanced patient responsibility and patient assistance programs
to continue in line with the rates since the introduction of that program in July 2023.
Dr Meintjes said: “While this determination will have an impact on our current and future
commercialization plans, it simultaneously emphasizes that our focus on rigorous clinical
evidence generation as a path to gaining coverage certainty through guidelines inclusion is the
right focus for our business. This program is at the center of our efforts to regain Medicare
coverage.’
Pacific Edge will be hosting a conference call and webcast to discuss the determination today
(Monday 13 January 2025) at 11.00am NZST:
This update will be available via webcast by the following link:
www.virtualmeeting.co.nz/pebiu25 or by phone on the following toll-free numbers:
• New Zealand: 0800 005 652
• Australia: 1800 953 093
Questions
Questions can be submitted online in writing via the Webcast platform or verbally via the audio
call when prompted.

The new ‘Genetic Testing in Oncology: Specific Tests’ (L39365) LCD can be accessed HERE

The response to comments on the draft LCD ‘Genetic Testing for Oncology’ (DL39365) can be
accessed: HERE
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 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.

---

NOVITAS LCD
INVESTOR PRESENTATION
Chris Gallaher
Chairman
Dr Peter Meintjes
Chief Executive Officer
13 January 2025

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IMPORTANT NOTICE AND DISCLAIMER
2

PACIFIC EDGE’S MEDICARE JOURNEY
3
Novitas informs
Pacific Edge that
Cxbladder is
covered (A58529,
retired Nov ’22)
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 22 - May ’23
Triage gains
coding and
reimbursement
under LCA
(A58917)
Jan ’23
Novitas finalizes
LCD (L39365) with
non-coverage for
Cxbladder, future
effective on 17 July
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
July ’23
Participated in
Novitas’ open notice
& comment process
Engaged with CMS
Published STRATA
Novitas agrees to
review PPT & STRATA
Aug ’23 – May ’24
Novitas finalizes
LCD under a new
name: ‘Genetic
Testing in
Oncology:
Specific Tests’
(L39365)’
July ’24
Jan ’25
CMS grants an
extension to
Novitas to ensure
all comments can
be considered
Novitas is the Medicare Administrative
Contactor (MAC) with jurisdiction for Pacific
Edge’s US laboratory.
Published AV
Paper on all
existing Cxbladder
products
Novitas agrees to
review
Aug ’24
Aug ’24
C21 and other
stakeholders
meet with CMS
regarding
Extension

‘GENETIC TESTING IN ONCOLOGY: SPECIFIC TESTS’ (L39365)
FINDINGS
•Finalized LCD no longer relies on 3
rd
party databases/compendia
•Finalized LCD no longer preemptively non-covers non-commercial tests
•Finalized LCD has been reduced to an evidentiary review and non-coverage
determination of specific tests including Cxbladder, concluding that
“Cxbladder tests are not reasonable and necessary to support positive
outcomes in the management of bladder cancer”
•Finalized LCD repeats concerns detailed in the original draft:
•Conflates hematuria evaluation with screening
•Insufficient validation in confounding clinical circumstances
•Low PPV and high numbers of false positives
•Questions credibility of Pacific Edge funded research
MEDICARE IS PACIFIC EDGE’S LARGEST PAYER
•Medicare and Medicare Advantage is the largest global opportunity in bladder
cancer diagnostics from a single coverage decision
•In 1H 25 Medicare and Medicare Advantage delivered ~5,300commercial tests
(~54% of US commercial tests) and ~$6.5m NZD in total operating revenue
(~59% of total operating revenue)
•Pacific Edge expects to be reimbursed at US$760/test until 23 February 2025
1. Novitas is the Medicare Administrative Contractor for Pacific Edge’s US laboratory. It is empowered by the Centers for Medicare and Medicaid Services (CMS) to make the
coverage determination, but it is accountable to CMS for the decision.
4
US COMMERCIAL TEST VOLUMES AND ASP* (US$)
7,476
8,276
10,622
12,450
13,550
9,956
9,911
$472
$470
$493
$519
$562
$613
$618
$-
$100
$200
$300
$400
$500
$600
$700
-
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
1H 222H 221H 232H 231H 242H 241H 25
US$ AVERAGE TEST SALE PRICE
TEST VOLUME
US ASP (RHS)

NOVITAS CONTINUES TO MISUNDERSTAND THE VALUE OF CXBLADDER
•Appears to misunderstand the intended patient population and the important role that
biomarkers can play in risk stratifying hematuria patients
•Appears to assume Cxbladder products are a screening test
•Fails to consider new peer reviewed evidence, despite notifying Pacific Edge in writing that it
would incorporate that evidence:
•the STRATA
1
randomized control study published in July 2024, which demonstrated the
Clinical Utility (CU) of Cxbladder Triage
•the analytical validation data of Cxbladder Detect, Triage and Monitor published in
September 2024
•Does not acknowledge:
•A Journal of Urology editorial noting the clinical value of Cxbladder
•Representations on the draft LCD calling for calling for continued Medicare coverage of
Cxbladder during the ‘Notice and Comment’ period in 2023
•the American Urological Association (AUA)
•the Large Urology Group Practice Association (LUGPA), and
•the American Association of Clinical Urologists (AACU)
•Coalition for 21st Century Medicine (C21), and
•the American Clinical Laboratory Association (ACLA)
•Repeats its flawed analysis of the existing Cxbladder test evidence by focusing on the
biomarker discovery study by Holyoake et al in 2008
4
and creates confounded conclusions by
lumping the evidence in future publications from all assays together
•Does not explicitly clarify whether hematuria is or is not substantiated suspicion of disease
•If not, LCD should have no scope to non-cover non-oncologic tests like Triage and Detect
5
1. Lotan et al (2024). A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The Safe Testing of Risk for
Asymptomatic Microhematuria Trial. J Urol 2024.
2. Harvey et al (2024) Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma. Dia gnostics. 2024; 14(18):2061.
3. Anderson C. (2024) What Is the Future of Cystoscopy for Detecting Urothelial Carcinoma? J Urol. Vol. 212, 399-400, September 2024.
4. Holyoake et al (2008) Development of a multiplex RNA urine test for the detection and stratification of transitional cell carcinoma of the bladder. Clin Cancer Res 2008;14:742–9.

VALUE CREATION THROUGH A FOCUS ON THREE PILLARS
6
WE PREPARED FOR THIS OUTCOME
•We have re-focused the business on clinical development for
guidelines inclusion and increased coverage certainty for
Detect Plus & Monitor Plus
•We have restructured our commercial operations to focus on
profitable territories
•We have adjusted our selling focus towards the clinical value
of Cxbladder as the driver of higher throughput/headcount
and throughput/clinician and health economics messaging
•The company is well placed to fund the re-coverage process if
necessary and regain reimbursement for our tests

SETTING A ROUTE TO REGAINING MEDICARE COVERAGE
7
ACTIVATING OUR CONTINGENCY PLANS
•Potential legal challenge to the LCD on procedural and fairness grounds
•Further review the structure of our operations and our strategy to reduce cash burn in line with our plan to regain
Medicare coverage
•Submit a reconsideration request to Novitas regarding the evidence not already considered of the Journal of
Urology’s publication of the STRATA
1
study and the updated Analytical Validation studies of Triage, Detect and
Monitor
2
•Continue to advance our clinical evidence generation program in an AV/CV/CU framework for Guidelines inclusion
by the AUA and NCCN
•Continue to publish evidence from our partnership with Kaiser Permanente
•Continue to explore other strategic alternatives for Pacific Edge that could support the company through regaining
Medicare coverage and advancing the commercialization of Cxbladder globally
1. Lotan et al (2024). A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The Safe Testing of Risk for Asymptomatic
Microhematuria Trial. J Urol 2024.
2. Harvey et al (2024) Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma. Diagnostics. 2024; 14(18):2061.

CLINICAL EVIDENCE CATALYSTS FOR COVERAGE CERTAINTY
Pacific Edge will also lodge a reconsideration request if Cxbladder is included in the American
Urological Association (AUA) or National Comprehensive Cancer Network (NCCN) guidelines
MEDICARE RECONSIDERATION AND GUIDELINE INCLUSION REQUESTS
(Novitas
1
typically handles reconsideration requests on existing LCDs within three months of submission)
CatalystTest and evidence standard
(2)
Expected date of reconsideration request
(3)
1. STRATA data published-CU of TriageNovitas notified of the publication in April
2. Automated RNA and DNA extraction-AV of Triage, Detect and MonitorQ3 2024 (Published September, Novitas notified)
3. Triage Plus Analytical Validation-AV of Triage Plus Q2 2025
4. DRIVE data published-CV of Triage PlusQ2 2025
5. STRATA concordance -CU of Triage Plus (concordance)Q3 2025
6. Kaiser Permanente RWE
4
published-CU of Triage (RWE) Q3 2025
5
7. AUSSIE data published-CVof Triage PlusQ4 2025
8. microDRIVE published-CV of Triage PlusQ1 2026
9. Monitor Plus Analytical Validation-AV of Monitor PlusQ2 2026
10. Pooled CV data published
6
-CV of Triage PlusQ2 2026
11. LOBSTER published-CV of Monitor/Monitor PlusQ1 2027
12. CREDIBLE data published-CU of Triage PlusQ3 2027
1
Novitas is the Medicare Administrative Contractor (MAC) charged with making the Medicare local coverage determination for Pacific Edge’s US laboratory
2
AV, CV CU, respectively Analytical Validity, Clinical Validity, Clinical Utility
3
All dates are calendar year rather than financial year and our best current estimates
4
RWE is Real World Evidence
5
Timeline determined by Kaiser Permanente
6
The pooled analysis brings together data from DRIVE, AUSSIE and microDRIVE
8

1,563
Low-risk patients took a
Cxbladder Triage test
Patients:
- Had no history of
gross hematuria; or
- Refused cystoscopy
1,200 (77%)
NEGATIVE RESULT
Avoided a cystoscopy
363 (23%)
POSITIVE RESULT
Identified as ‘high-risk’
of cancer
310
Underwent a
cystoscopy
19
Diagnosed with cancer
(6.1% of those
examined)
INDEPENDENT REAL-WORLD EVIDENCE OF CXBLADDER’S CLINICAL UTLITY
CLINICAL UTILITY EVIDENCE OF CXBLADDER TRIAGE THAT SUPPORTS MEDICARE COVERAGE
1.
Real World Clinical Utility of a Urinary Biomarker (Cxbladder Triage) for Hematuria Referrals in an Integrated Managed Care Health System. Abstract accepted for presentation to
the Western Section of the American Urological Association annual conference.
KAISER PERMANENTE ABSTRACT SHOWS CLINICAL VALUE IN REAL WORLD SETTING
•Kaiser Permanente presented an abstract to the Western Section AUA conference
regarding their ongoing experience with Cxbladder Triage
•The abstract focuses on 1,563 low-risk patients in the Kaiser Southern California
health system with no history of gross hematuria or who refused cystoscopy
•1,200 patients avoided invasive cystoscopy, improving patient satisfaction,
urology access and lowering the overall cost of care
•A peer-reviewed publication is expected on the complete data set, targeting the
AUA conference in 2025
•Pacific Edge will use this future publication for a Medicare reconsideration request
(in the event of a non-coverage determination)
“Incorporating a highly reliable urine biomarker into clinical workflows for
hematuria reduced the burden of cystoscopy substantially, improving patient
satisfaction, urology access, and lowering overall cost of care,”
- Loo et al (2024)
1
9

AUA HEMATURIA GUIDELINES – A COMPREHENSIVE REVIEW
AN APPROACH THAT SUPPORTS OUR DRIVE FOR GUIDELINE INCLUSION
•The AUA has commenced a review of the microhematuria guideline and has asked for
professional comment on its initial draft; no timeframe provided
•The clinical utility of Cxbladder Triage demonstrated by the STRATA
1
study is expected
to be considered as part of the deliberations
•A positive AUA Journal of Urology editorial in July 2024 suggests favorable direction of
travel
•Clear/positive inclusion language would be used as the basis for a Medicare coverage
re-consideration request (in the event of a non-coverage determination)
“... these tests have the potential to improve the
management of our patients with suspected
[urothelial cancer] who would otherwise require an
invasive procedure for diagnosis.”
– Journal of Urology editorial Sept 2024
www.auanet.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, last
updated in 2020
1. Lotan et al. (2024) . A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The
Safe Testing of Risk for Asymptomatic Microhematuria Trial. The Journal of Urology Vol 212 1-8 Jul 2024.
10

SUMMARY AND OUTLOOK
11

OUTLOOK: MORE CATALYSTS THAN HEADWINDS
12
•We are disappointed with this decision, but have prepared for it
•We will focus on the available legal and appeals avenues in the next 45 days
•We will continue our evidence generation focus until re-coverage
•The company is well placed to fund the re-coverage process if necessary and regain reimbursement
for our tests
HEADWINDS:
•Customer response to the non-coverage determination
•Negative physician or patient response to expanding the enhanced patient responsibility program
CATALYSTS:
•Potential inclusion in the AUA Microhematuria Guidelines
•Reconsideration of already-published Clinical Evidence
•STRATA publication on the CU of Triage
•AV publication for Triage, Detect and Monitor
•Reconsideration of new Clinical Evidence
•AV publication for Triage Plus
•DRIVE publication for Triage Plus
•Cxbladder Triage Plus pricing via Gapfill
•New clinician-generated CU evidence as studies completed (particularly Kaiser)
•Litigation success

APPENDIX

PACIFIC EDGE’S EVIDENCE PROGRAM SEEKS TO CHANGE CLINICAL PRACTICE
Clinical Evidence
AV, CV, CU
HEALTHCARE PAYERS
(Medicare, Kaiser
Permanente, Veterans
Administration, private
payers, etc).
- Change Medical Policy
(practice)
- Change Reimbursement
Policy
PROFESSIONAL SOCIETIES
(AUA, EAU, NCCN)
- Change Standard of Care
Guidelines
Guidelines change:
- Healthcare Payer Medical
and Reimbursement
Policies
Guidelines change:
- Clinical Practice
UROLOGISTS - Change Clinical Practice
STRUCTURED CLINICAL EVIDENCE DEVELOPMENT
•Pacific Edge’s clinical study program is focused on developing clinical evidence for Cxbladder tests in a structured framework
•Analytical Validity (AV): Evidence that a test is repeatable in the lab for a given indication and population
•Clinical Validity (CV): Evidence a test works in the same way on an independent eligible population for a given indication
•Clinical Utility (CU): Evidence that a test changes clinical practice in the hands of a physician, typically in prospectively recruited RCTs
•Real World Evidence (RWE): CU verification of the real-world use of the test in clinical practice, usually through regular use of the test by physicians
•Clinical Utility evidence obtained through randomized control trials is required to change standard of care guidelines (in addition to AV and CV evidence)
AUDIENCE
EVIDENCE USE
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SUMMARY OF CLINICAL EVIDENCE
StudyPop. TypeSensitivity (Sn)NPVSpecificity (Sp)Comment
Triage Plus
Proof o f
concept
Lotan et al., 2022MH + GH*97%99.7%90%Pooled data from US and Singapore cohorts (n=804). Called Detect+ in publication.
CV
DRIVE (unpublished) (1)MH + GH*Study in progress
AUSS IE (unpublis hed) (4)MH + GH*Study in progress
microDRIVE (unpublished) (5)MH*Study in progress
CUCREDIB LE (not s tarted)(6)MHProtocol in final development stages , site selection s tarting by the end of 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
res ults (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 cystos copy & were
managed at primary care (6)
Lotan et al., 2024 (7)MH + GH*90%99%56%
Showed clinicians using Triage undertook 59% fewer cys toscopies on low-risk patients
pres enting with hematuria.
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
Health
Economics
Tyson et al., 2023 MH
Published economic model shows significant savings for healthcare payers (median savings of
$559 in direct costs per patient)
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
res ults (n=153, 6)
CUKoya et al., 2020(7)
Integration of C xb Monitor into the surveillance schedule reduced annual cystoscopies (39%)
(8,9)
CULi et al., 2023(7)
Cxbladder Monitor safely postpones a patient’s next scheduled cystoscopy, the current ‘gold
standard’ for bladder cancer surveillance
* Referred patients. Definitions - MH: Microhematuria, GH: Gross Hematuria. For Sensitivity, NPV and Specificity please see page 41 of this presentation

FOOTNOTES FOR CLINICAL EVIDENCE SUMMARY
Footnotes
Triage Plus
1Observational study to validate per formance characteristics and clinical utility of Cxbladder tests (Cxb Triage, Cxb Detect, Cxb Triage Plus).
2Observational study to validate per formance characteristics of Cxb Triage Plus 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, Cxb Triage Plus).
5Observational study to validate performance characteristics of Cxb Triage Plus in microhematuria (MH) patients.
6Clinical utility study comparing the reduction of cystoscopy use when implementing the new clinical pathway to SOC in a defined MH population.
Triage
1Cxb Triage performance; Cxb Triage & imaging combined performance had a Sn of 97.7% & NPV of 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 Sn of 98.1%, NPV of 99.9% & Sp of 98.4%.
6Cxb Triage negative rate was 53%; Follow-up period of 21-months showed no missed cancers, demonstrating safety.
7Cxb Triage demonstrated to have clinical utility in safely risk stratifying 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, Cxb Detect
+
).
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 Sn of 93% and NPV of 94% on patients with recurrent UC.
3Using Kavalieris et al., (2017) data set, Lotan et al., (2017) compared relative per formance 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
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REFERENCES SUMMARY OF CLINICAL EVIDENCE
References
Triage Plus
Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cx bladder Tests and Improves Patient Risk Stratification
1
.The Journal of Urology, 10-1097.
Triage
Davidson et al., (2019). Inclusion of a molecular mar ker 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 haematur ia that r educes 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 fr om a urine sample to triage outpatients 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 Cx bladder Tests and Improves Patient Risk Stratification.The Journal of Urology, 10-1097.
Lotan et al. (2024) . A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The Safe Testing of Risk for Asymptomatic
Microhematuria Trial. The Jour nal of Ur ology Vol 212 1-8 Jul 2024.
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 ur ine 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 of patients previously treated for bladder cancer.BMC urology,20(1), 1-9.
Lotan et al., (2017). Clinical comparison of non-invasive urine tests for ruling out recurrent urothelial carcinoma. Urologic Oncology: Seminars and Original Investigations, 35 (8), 531-539.
Li et al., (2023). Cxbladder Monitor testing to reduce cystoscopy frequency in patients with bladder cancer. Urologic Oncology: Seminar s and Original Investigations, 41 (7), 326.e1 – 326.38.
17
1.Triage Plus was called Detect+ in this publication

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 3 577 6733 Within NZ 0800 555 563
email: investors@pacificedge.co.nz
www.pacificedgedx.com
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