Quarterly Update – Cxbladder Test Volumes Steady in Q4 24

9 APRIL 2024
CXBLADDER TEST VOLUMES STEADY IN Q4 24
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today
announces tests processed at its laboratories in the three months to the end of March 2024
were steady on the prior quarter.
The result, achieved with a smaller sales force, has benefited from previously reported
improvements in sales force efficiency and a growing contribution of tests from Kaiser
Permanente following the incorporation of Cxbladder tests into its electronic medical records
system. In addition, throughput in Q4 24, has been supported by a traditional seasonal catch
up in the US after the slow Thanksgiving-Christmas holiday period and sustained ordering from
physicians.
Volumes in Q4 24
1
rose to 7,210 tests, a figure up 0.4% on the 7,183 tests in Q3 24. US
volumes were 6,099 tests up 1.0% on the 6,041 tests of the prior quarter. Asia Pacific volumes
were down 2.7% on the prior quarter to 1,111 tests, with the result impacted by the traditional
slowdown in New Zealand post the Christmas period.
We entered Q4 24 with fewer sales reps, down to an average of 16 FTEs across the quarter
from 21 FTEs in Q3 24. This drop reflects the lagged impact of the reorganization in Q2 24 and
other initiatives aimed at preserving capital. The combination of fewer FTEs and efficiency
gains has driven our sales force efficiency metric up 30.4% (381 tests per average FTE over
the quarter in Q4 24 vs 292 in Q3 24).
Tests per unique ordering clinician (our preferred metric for measuring customer commitment
to Cxbladder) increased to 6.7 in Q4 24, from 5.9 in Q3 24 reflecting efficiency improvements
and the company’s determination for sales territories to operate profitably.
Test volumes for the 12 months to the end of March 2024 (FY 24) were up 3.4% to 32,633
from 31,565 in FY 23 with the easing of growth reflecting the ongoing uncertainty over Medicare
coverage and the associated reorganization.
Further details on test volumes and other developments in the quarter are included in the
investor update released today.
Released for an on behalf of Pacific Edge by Grant Gibson, Chief Financial Officer.
For more information:
Investors: Media:
Dr Peter Meintjes Richard Inder
Chief Executive The Project
Pacific Edge P: +64 21 645 643
P: 022 032 1263

1
Volumes in some prior quarters of FY24 are marginally different from those reported in earlier investor
updates reflecting post period adjustments.

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

---

INSIDE
Letter from the CEO 2
Q4 test volumes 3
STRATA study results 5
DETECT
+
commercialization 7
Medicare coverage 8
Clinical study update 9
APRIL 2024

PACIFIC EDGE LIMITED INVESTOR UPDATE | APRIL 2024
2
LETTER FROM THE CEO
DEMONSTRATING
RESILIENCE
Dear Shareholders,
As I have reflected on our
achievements of the fourth quarter
and my second full financial year
leading the company, I am left
with a sense of gratitude for the
extraordinary efforts of my team.
I am also confident in our ability to
address future challenges.
Our navigation of the Medicare
coverage uncertainty alongside our
diligent work ethic in overcoming
the typical challenges that fast-
growing companies face, have
demonstrated a resilience that
justifies investor confidence in our
prospects.
We have been tested by a series
of unpredictable events, but remain
firmly focused on the actions that
drive results:
• generating compelling clinical
evidence for our existing urology
products to ensure clinically
validated molecular tests for
guidelines inclusion and payer
coverage; and
• commercializing those clinically
validated molecular tests through
defined clinical pathways at
secondary care and community
practice in urology.
This focus is also evident with
the progress we report in today’s
investor update. We have delivered
steady quarter-on-quarter test
volumes (see page 4). We achieved
this increase with a smaller, but
more efficient sales force and one
that is focused on selling the clinical
utility of Cxbladder and the value it
offers healthcare payers.
Certainly, a Medicare non-
coverage determination would
impact our volumes, but we expect
it would be temporary, because
we are confident that our clinical
study program provides the
foundations to regain coverage
from any possible non-coverage
determination.
Indeed, today we provide
several key successes that further
demonstrate our program will
deliver the endpoints of analytical
validity (AV), clinical validity (CV)
and clinical utility (CU) needed for
coverage and inclusion in clinical
guidelines. And, with the support
of a comprehensive medical
communications program, that it will
drive momentum in the adoption
of our tests through defined clinical
pathways.
“STRATA is... the
strongest evidence
yet for inclusion of a
Cxbladder product in
the AUA Guidelines.”


The first paper from our STRATA
study (page 5), which successfully
concluded enrolment in July 2023,
has been accepted by the American
Urological Association (AUA) for a
podium presentation at its Annual
Meeting in San Antonio, Texas,
May 3-6. Furthermore, we were
requested to submit a manuscript
prepared from the same data for
publication in the Journal of Urology
edition that coincides with the AUA
Annual Meeting, but are yet to be
advised of its acceptance.
The paper for the AUA and
the manuscript focuses on the
CU of Cxbladder Triage in safely
reducing the need for cystoscopies
(established as a reduction of 59%
in low-risk hematuria patients in
this study). It will also confirm the
previously published accuracy of the
test for all patient types in the study
design.
STRATA is the first ever
randomized controlled trial of a
urine biomarker for hematuria
evaluation and provides the
strongest evidence yet for inclusion
of a Cxbladder product in the AUA
Guidelines. Huge kudos goes to
the Clinical and Medical teams
under the leadership of Dr. Tamer
Aboushwareb who challenged
the team to bring forward this
publication by more than nine
months to meet the AUA publishing
deadlines for inclusion in this year’s
annual meeting.
Further publications leveraging
STRATA data will directly
compare Detect
+
against Triage
to demonstrate equivalent or
better clinical utility, and superior
performance characteristics in
clinical validation. Data collected
from the study has also been used
to increase the size of the discovery
dataset to further improve the
Detect
+
algorithm.
As we set out on page 8, each
publication of new AV, CV or CU
evidence offers us an opportunity to
either entrench coverage, or in the
event of a Medicare non-coverage
decision, an opportunity to regain it
through a reconsideration request.
The steps we have taken over
the last two years, many of which
have been implemented on an
accelerated timeline, give us the
confidence that any loss of coverage
can be regained with our current
cash reserves.

Shifting focus to future products,
we also report on our progress to
commercialize Cxbladder Detect
+
,
which over the longer term we
expect to become our sole test for
hematuria evaluation.
We previously noted for investors
that we have received a CPT Code
for Detect
+
(0420), which was made
effective on 1 January 2024. We
now turn our attention to the pricing
of the test, where we will pursue a
‘Crosswalk’ strategy that we outline
on page 7.
Medicare’s pricing process
is typically a straight- forward
mathematical calculation based
on technological similarities
to previously priced tests. In
accordance with this, we are seeking
a higher price and a higher margin
that could meaningfully strengthen
the underlying economics of our
business, specifically the economics
of operating the Account Executives
in our Direct Sales team.
With the release of our FY 24
financial results in May, we expect to
further demonstrate the progress we
are making towards a more-efficient
operation. As we signaled in the Q3
24 investor update, our sales team
has made good progress towards
operating at breakeven and cash
outflow is now driven almost entirely
by long-term strategic imperatives.
Finally, before closing I want
to acknowledge the support and
commitment of Chairman Chris
Gallaher and Non-Executive Director
Mark Green, who last month
announced their intention to retire
from the Pacific Edge Board (see
page 6).
Both Directors have pulled
out all the stops for Pacific Edge,
supporting my transition into the
Chief Executive role and assisted in
driving the change that now gives us
such confidence in the future.
Chris in particular deserves
recognition for his leadership of the
Board and putting Pacific Edge on a
footing that positions us for success
no matter the short-term coverage
challenges we face.
I look forward to further updating
you on our progress in May.
Dr Peter Meintjes
Chief Executive
TEST VOLUMES
VOLUMES STEADY AMID EFFICIENCY IMPROVEMENTS
Cxbladder tests processed at Pacific Edge’s laboratories in the three months to the end of March 2024 were
steady on the prior quarter.
The result, achieved with a smaller sales force, has benefited from previously reported improvements in sales
force efficiency and a growing contribution of tests from Kaiser Permanente following the incorporation of
Cxbladder tests into its electronic medical records system. In addition, throughput in Q4 24, has been supported
by a traditional seasonal catch up in the US after the slow Thanksgiving-Christmas holiday period and sustained
ordering from physicians.
Volumes in Q4 24
1
rose to 7,210 tests, a figure up 0.4% on the 7,183 tests in Q3 24. US volumes were 6,099 tests
up 1.0% on the 6,041 tests of the prior quarter. Asia Pacific volumes were down 2.7% on the prior quarter to 1,111 tests,
with the result impacted by the traditional slowdown in New Zealand post the Christmas period.
We entered Q4 24 with fewer sales reps, down to an average of 16 FTEs across the quarter from 21 FTEs in Q3 24.
This drop reflects the lagged impact of the reorganization in Q2 24, and other initiatives aimed at preserving capital.
The combination of fewer FTEs and efficiency gains has driven our sales force efficiency metric up 30.4% (381 tests
per average FTE over the quarter in Q4 24 vs 292 in Q3 24).
Tests per unique ordering clinician (our preferred metric for measuring customer commitment to Cxbladder)
increased to 6.7 in Q4 24, from 5.9 in Q3 24 reflecting efficiency improvements and the company’s determination for
sales territories to operate profitably.
Test volumes for the 12 months to the end of March 2024 (FY 24) were up 3.4% to 32,633 from 31,565 in FY
23 with the easing of growth reflecting the ongoing uncertainty over Medicare coverage and the associated
reorganization.
Test volumes processed through our US laboratory rose 3.3% in FY 24 over FY 23 to 28,102. Tests processed at
our Dunedin Laboratory for the APAC region rose 4.2% over the same period to 4,531 tests.
1
Volumes in some prior quarters of FY24 are marginally different from those reported in earlier investor updates reflecting post period adjustments.
PACIFIC EDGE LIMITED INVESTOR UPDATE | APRIL 2024
3
LETTER FROM THE CEO CONTINUED

-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
Q4 21
3,824
1,073
4,897
Q1 22
4,277
1,079
5,356
Q2 22
4,706
1,074
5,780
Q3 22
4,591
1,117
5,708
Q4 22
5,290
952
6,242
Q1 23
6,073
983
7,056
Q2 23
6,699
1,165
7,864
Q3 23
6,629
1,139
7,768
Q4 23
1,061
8,877
Q1 24
8,627
1,079
9,706
Q2 24
7,335
1,199
8,534
Q3 24
6,041
1,142
7,183
Q4 24
6,099
1,111
7,210
APAC
-
200
400
600
800
1,000
1,200
1,400
1,600
-
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
US Ordering Clinicians
Tests/Clinician
US ORDERING CLINICIANS (LHS)
Q4 21
530
Q1 22
657
Q2 22
690
Q3 22
741
Q4 22
789
Q1 23
895
Q2 23
978
Q3 23
1,082
Q4 23
1,150
Q1 24
1,232
Q2 24
1,147
Q3 24
1,016
Q4 24
915
TESTS/ORDERING CLINICIANS (RHS)
7.2
7.0
6.5
6.8
6.2
6.1
6.7
6.8
6.8
6.4
6.8
-
10
20
30
40
50
60
-
50
100
150
300
200
250
70350
80400
Average Sales FTE
Average US Test Volume/Sales FTE
US AVERAGE SALES FTE (LHS)US TEST VOLUMES/SALES FTE (RHS)
200
202
160
187
222
226
201
239
288
265
21
Q1 22Q4 21
23
Q2 22
29
Q3 22
28
Q4 22
27
Q1 23

30
Q2 23
33
Q3 23
33
Q4 23
30
Q1 24
28
Q2 24
21
Q3 24
16
Q4 24
292
381
6.7
5.9
7,816
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
Q4 21
3,824
1,073
4,897
Q1 22
4,277
1,079
5,356
Q2 22
4,706
1,074
5,780
Q3 22
4,591
1,117
5,708
Q4 22
5,290
952
6,242
Q1 23
6,073
983
7,056
Q2 23
6,699
1,165
7,864
Q3 23
6,629
1,139
7,768
Q4 23
1,061
8,877
Q1 24
8,627
1,079
9,706
Q2 24
7,335
1,199
8,534
Q3 24
6,041
1,142
7,183
Q4 24
6,099
1,111
7,210
APAC
-
200
400
600
800
1,000
1,200
1,400
1,600
-
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
US Ordering Clinicians
Tests/Clinician
US ORDERING CLINICIANS (LHS)
Q4 21
530
Q1 22
657
Q2 22
690
Q3 22
741
Q4 22
789
Q1 23
895
Q2 23
978
Q3 23
1,082
Q4 23
1,150
Q1 24
1,232
Q2 24
1,147
Q3 24
1,016
Q4 24
915
TESTS/ORDERING CLINICIANS (RHS)
7.2
7.0
6.5
6.8
6.2
6.1
6.7
6.8
6.8
6.4
6.8
-
10
20
30
40
50
60
-
50
100
150
300
200
250
70350
80400
Average Sales FTE
Average US Test Volume/Sales FTE
US AVERAGE SALES FTE (LHS)US TEST VOLUMES/SALES FTE (RHS)
200
202
160
187
222
226
201
239
288
265
21
Q1 22Q4 21
23
Q2 22
29
Q3 22
28
Q4 22
27
Q1 23

30
Q2 23
33
Q3 23
33
Q4 23
30
Q1 24
28
Q2 24
21
Q3 24
16
Q4 24
292
381
6.7
5.9
7,816
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
Q4 21
3,824
1,073
4,897
Q1 22
4,277
1,079
5,356
Q2 22
4,706
1,074
5,780
Q3 22
4,591
1,117
5,708
Q4 22
5,290
952
6,242
Q1 23
6,073
983
7,056
Q2 23
6,699
1,165
7,864
Q3 23
6,629
1,139
7,768
Q4 23
1,061
8,877
Q1 24
8,627
1,079
9,706
Q2 24
7,335
1,199
8,534
Q3 24
6,041
1,142
7,183
Q4 24
6,099
1,111
7,210
APAC
-
200
400
600
800
1,000
1,200
1,400
1,600
-
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
US Ordering Clinicians
Tests/Clinician
US ORDERING CLINICIANS (LHS)
Q4 21
530
Q1 22
657
Q2 22
690
Q3 22
741
Q4 22
789
Q1 23
895
Q2 23
978
Q3 23
1,082
Q4 23
1,150
Q1 24
1,232
Q2 24
1,147
Q3 24
1,016
Q4 24
915
TESTS/ORDERING CLINICIANS (RHS)
7.2
7.0
6.5
6.8
6.2
6.1
6.7
6.8
6.8
6.4
6.8
-
10
20
30
40
50
60
-
50
100
150
300
200
250
70350
80400
Average Sales FTE
Average US Test Volume/Sales FTE
US AVERAGE SALES FTE (LHS)US TEST VOLUMES/SALES FTE (RHS)
200
202
160
187
222
226
201
239
288
265
21
Q1 22Q4 21
23
Q2 22
29
Q3 22
28
Q4 22
27
Q1 23

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

CLINICAL UTILITY EVIDENCE FOR TRIAGE
STRATA STUDY RESULTS
The first paper from our STRATA
1
study – one showing
conclusive evidence of Cxbladder Triage’s clinical utility – will
be presented in May to the American Urological Association
(AUA) annual conference, the world’s most important urology
meeting.
The paper demonstrates Cxbladder Triage can help
clinicians to safely and more effectively risk-stratify low-
risk hematuria patients when compared to AUA guidelines.
Specifically, clinicians undertook 59% fewer cystoscopies on
patients in the test arm of the study, when they could use
information generated by a Cxbladder Triage test to help them
determine the intensity of a patient workup.
Referencing the clinical utility of the test, authors of the
paper led by UT Southwestern Professor of Urology Dr Yair
Lotan, said: “Cxbladder Triage can help reduce the burden of
unnecessary cystoscopies... resulting in less patient morbidity
and discomfort, improved access to care, and reduced
environmental impact.”
STRATA is the first ever randomized controlled trial of a
urine biomarker for hematuria evaluation and this paper is
the strongest clinical utility evidence yet for inclusion of a
Cxbladder product in the AUA Guidelines. Similarly, Pacific
Edge expects to use this publication in any Medicare coverage
reconsideration or redetermination process.
Pacific Edge submitted an abstract summarizing the draft
results from STRATA for consideration at the AUA Meeting.
Recognizing the paradigm-shifting and practice-changing
nature of STRATA’s results during the review of the abstract,
the AUA invited Pacific Edge to submit a full manuscript for
peer-review. While, the manuscript is still in the process of peer
review, it will form the basis of a podium presentation at the
AUA Meeting during a session covering advances in bladder
cancer.
The evidence accumulated during STRATA included a total
of 449 patients of which 205 were assessed as low risk and
were randomized to either the control arm (where the results
of the test were not shared with the clinician) or test arm
where clinicians were provided a Cxbladder Triage result. Of
those in the control arm, 67% elected to have a cystoscopy,
while 27% in the test arm elected to have a cystoscopy.
Importantly, no cancers have yet been found in any of the
test arm patients who had a negative Triage test throughout
the AUA-recommended follow up period of 3-24 months, thus
further demonstrating that avoiding cystoscopies can be done
safely with appropriately validated urine biomarkers.
The AUA Annual Meeting is expected to attract more than
10,000 delegates from around the world and is to be held in
May 3-6 in San Antonio, Texas. https://www.auanet.org
The abstract of the paper is available on our website.
1
Safe Testing of Risk for AsymptomaTic microhematuriA.
STRATA TO
SUPPORT DETECT
+

While the primary endpoints
for STRATA have been met and
will be published and presented
at the AUA conference, the data
generated in this study will be
leveraged going forward to
demonstrate the clinical utility of
Detect
+
, which over the long-term
is expected to become our sole
test for hematuria evaluation.
Pacific Edge has already
established the superior analytical
performance of Detect
+
and will
undertake analyses to demonstrate
equivalent clinical utility with
superior clinical validation in a
concordance study.
The studies necessary for
the clinical validation of Detect
+
,
DRIVE, microDRIVE and AUSSIE
studies and the subsequent pooled
analysis of all three, are continuing
to enroll broadly as expected.
They are expected to demonstrate
clinical validation of Detect
+

in microhematuria and gross
hematuria patients.
PACIFIC EDGE LIMITED INVESTOR UPDATE | APRIL 2024
5

AUTOMATION
NEW VALIDATION
DATA
Pacific Edge, as part of our
commitment to continuous
improvement, is automating the
extraction and processing of DNA
and RNA in patient samples, a
key step in the Cxbladder testing
process.
The new approach enhances our
ability to scale as demand for our
tests grow while reducing the use of
various chemicals in the extraction
procedure.
Importantly, this gives the
opportunity for Pacific Edge to
publish new Analytical Validation
data. This data, once published, will
allow healthcare payers, including
Novitas, the Medicare Administrative
Contractor with authority for our US
Laboratory, to more easily assess
the analytical validity of our tests.
It will also give Pacific Edge an
opportunity to apply for coverage
reconsideration should Novitas
make a Medicare noncoverage
determination.
We expect the required analytical
validation to be completed in the
next few weeks and are targeting the
publication of the data in the second
or third quarter of this calendar year.
Pacific Edge Chair Chris
Gallaher and Non-Executive
Director Mark Green have
given advanced notice of their
intention to step aside from the
Board later this year, delivering
stability as the company
navigates the continued
Medicare uncertainty.
Mr Gallaher, who joined
the Pacific Edge Board in July
2016, has resolved to reduce his
governance commitments, and
has indicated his intention to
retire from the Board following
the appointment of a successor
and a structured handover at
the end of this year.
Meanwhile, with his
family moving to New York
later this year, Mr Green has
notified the Board he does
not intend to seek re-election
at the company’s next Annual
Shareholders Meeting in
September. Mr Green joined the
Pacific Edge Board in May 2021.
Mr Gallaher said: “It has long been my declared intention to
reduce my governance commitments when I turned seventy,
which I will later this year. Pacific Edge is on the threshold
of a new phase of development, with Medicare’s upcoming
determination, either way, having implications for the long-
term future and strategy for the company.
“I have great confidence in the future of Pacific Edge.
We have over the last two years established a dedicated
and skilled management team under Chief Executive
Dr Peter Meintjes to develop our world-leading technology
with comprehensive clinical evidence generation and drive
adoption in the US market.
“I want to thank my fellow directors for the support and
council over my tenure. On behalf of shareholders, I also want
to thank Mark for his support and service to the company. I
am looking forward to working with the whole team during
this period of transition.”
The Board’s Nomination Committee has commenced a
process to appoint a new Chair and consider the recruitment
of new Independent Directors.
GOVERNANCE
STABILITY THROUGH
UNCERTAINTY
Chris Gallaher
Mark Green
PACIFIC EDGE LIMITED INVESTOR UPDATE | APRIL 2024
6
Chief Technology Officer Dr Justin Harvey
with a Hamilton liquid handling platform, one
piece of equipment that helps to automate
Cxbladder sample processing.

DETECT
+
COMMERCIALIZATION
DETECT
+
PRICING MAY LIFT BUSINESS ECONOMICS
1
A CPT (Current Procedural Terminology) code is a medical code used to describe medical, surgical, and diagnostic services and procedures in the US
healthcare system.
Successful execution on this process has the
potential to strengthen the economics of Detect
+

and, given our goal of making it the sole test for
hematuria evaluation, the potential to significantly
strengthen the underlying economics of the direct
sales team and the company.
“The Medicare price sets a benchmark for all
other US healthcare payers. Our goal therefore is to
seek a price that recognizes the value of our new
test to clinicians and healthcare payers,” says Chief
Executive Dr Peter Meintjes.
Pacific Edge is seeking pricing for Detect
+

through the Centers for Medicare & Medicaid
Services (CMS) ‘Crosswalk’ process. It benchmarks
Detect
+
against comparable tests that have a similar
clinical and resource usage profile, typically based
on the underlying technology.
The price for our existing tests ($760) provides
the best available reference for the RNA component
of Detect
+
. To price the DNA component, we will
identify for CMS an appropriate comparable test
with the greatest technological similarity and
resource usage to our workflow and seek to add
the already established price of the two together to
determine the price of the combined product.
If successful, we expect that Detect
+
will have
a higher price and higher gross margin than our
current tests, changing the underlying economics
of Cxbladder customer acquisition and the
profitability profile for adding sales representatives.
We will submit our views to CMS in the middle
of the year and expect a preliminary determination,
potentially as soon as August.
If CMS determines there are no comparable
technologies (and therefore the ‘Crosswalk’
process is not appropriate) Pacific Edge will be
directed to the ‘Gap Fill’ process to determine the
Detect
+
price. The ‘Gap Fill’ approach involves CMS
soliciting feedback from all Medicare Administrative
Contractors on their estimate of the cost of the
test, a process that is likely to delay the pricing of
Detect
+
by a year.
DETECT
+
PRICING: THE PREREQUISITE FOR COMMERCIAL LAUNCH
Jul ‘23
Pacific Edge applied for
Detect
+
CPT code
1
Apr - Jun ‘24
Pacific Edge submits
‘Crosswalk’ arguments to
CMS for Detect
+
price
Aug - Oct ‘24
CMS posts proposed
payment determinations
(‘Crosswalk’, including
price or ‘Gap Fill’)
Nov - Dec ‘24
CMS final payments
determinations
Detect
+
CPT code
effective
Jan ‘24
CMS holds its Annual
Laboratory Meeting to
hear pricing submissions
Jun - Jul ‘24
Public comment,
consultation on draft
pricing determinations
Oct - Nov ‘24
- CMS prices published
and become effective
- ‘Gap Fill’ process
commences
Jan ‘25
PACIFIC EDGE LIMITED INVESTOR UPDATE | APRIL 2024
7
Pacific Edge, having achieved coding of Detect
+
, has turned its attention to Medicare pricing –
the next step towards commercial launch.

MEDICARE
CATALYSTS FOR MEDICARE COVERAGE CERTAINTY
Pacific Edge is well positioned, in the event of an unfavorable ‘Genetic testing for oncology’ (DL39365)
local coverage determination, to regain coverage.
All our studies are configured with the analytical validity (AV), clinical validity (CV), and clinical utility (CU)
endpoints sought by Novitas
1
, the broader urological community, and the clinical guidelines committees.
With each release of new data offering us an opportunity to lodge a reconsideration request for Medicare
coverage, we are confident we are steadily building what we believe will be an unassailable case. Meanwhile,
should any of our tests be included in clinical guidelines, we would also lodge a reconsideration request based on
the weight of clinical opinion.
Our efforts are also bolstered by a number of investigator-initiated trials. These trials are generally more
limited in scope than those undertaken by Pacific Edge, but they still offer endpoints expected to be supportive
of our existing portfolio of clinical evidence.
PACIFIC EDGE LIMITED INVESTOR UPDATE | APRIL 2024
8
‘Genetic testing for oncology’ LCD (DL39365)
Novitas
1
must finalize or withdraw DL39365 before 26 July 2024. In the event of a favorable determination,
Medicare coverage of any (or all) of Detect, Triage and Monitor (and potentially Detect
+
) will continue
uninterrupted. In the event of an unfavorable determination, Pacific Edge has:
- recourse to legal outcomes (which are subject to significant uncertainties over timelines and success); and
- opportunities to seek a reconsideration of coverage with the publication of new evidence (see below) or
the inclusion of tests in clinical guidelines based on the weight of clinical opinion.
Medicare reconsideration requests
(Reconsideration requests take Novitas
1
approximately 12 months to process from the lodging of a valid request)
CatalystTest and evidence standard
2
Expected date of reconsideration
request
3

1. ST R ATA data published - CU of TriageMay 2024
2. Analytical Validation of
automated RNA and DNA
extraction published
- AV of Triage, Detect, Detect
+
,
Monitor and Monitor
+

Q3 2024
3. DRIVE data published - CV of Detect
+

- CV of Triage
Q2 2025
4. microDRIVE published- CV of Detect
+
Q3 2025
5. AUSSIE data published - CV of Detect
+
Q4 2025
6. Pooled CV data published
4
- CV of Detect
+
Q1 2026
7. LOBSTER published - CV of Monitor/Monitor
+
Q1 2026
8. CREDIBLE data published - CU of Detect
+
Q1 2028
1
Novitas is the Medicare Administrative Contractor with authority 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.
4
The pooled analysis brings together data from DRIVE, AUSSIE and microDRIVE.

CLINICAL STUDY UPDATE
STRENGTHENING THE CLINICAL UTILITY CASE
STUDYGOALPOPULATION AND
USE
STATUS
STRATA
(Safe Testing of Risk
for AsymptomaTic
MicrohematuriA)
• CU for Triage
• CU for Detect
+

(retrospective)
• Microhematuria
• Risk stratification
- First paper to be published in May at the
AUA conference
DRIVE
(Detection and Risk
stratification In VEterans
presenting with
hematuria)
• CV for Detect
+

• CV for Triage and
within a Veterans’
cohort
• Data for pooled
analysis
• Micro and gross
hematuria
• Risk stratification
- Enrolment closed with 684 patients
across 10 VA sites
- Publication targeted for Q2 2025
microDRIVE
(Detection and Risk
stratification In VEterans
presenting with
hematuria)
• CV of Detect
+

• Data for pooled
analysis
• Microhematuria
• Detection
- Recruitment commenced November 2023
as a network study across all VAMCs
coordinated from a single US VA site
- 106 patients have consented for the study
with 84 samples received to date
- The target is 1000 patients with 35-50
tumor confirmed patients
- Target publication Q3 2025
AUSSIE
(Australian Urologic risk
Stratification of patientS
wIth hEmaturia)
• CV of Detect
+

with an Australian
cohort
• Data for pooled
analysis
• Micro and gross
hematuria
• Risk stratification
- Target enrolment: 600 patients across
three Australian sites
- Enrolment commenced September 2023
and 56 subjects are enrolled to date
- Target publication Q4 2025
POOLED ANALYSIS• CV of Detect
+
• Microhematuria
• Gross Hematuria
• Risk stratification
- Microhematuria and separately Gross
Hematuria patients from DRIVE, AUSSIE
and microDRIVE will be pooled and
performance determined
- Target publication Q1 2026
LOBSTER
(LOngitudinal Bladder
cancer Study for
Tumor Recurrence)
• CV of Monitor/
Monitor
+
• Surveillance
• Risk stratification
- Target enrollment is 426 subjects across
10 sites (US, Australia)
- Enrolment is now 227 subjects with 395
samples received to date
- The enrolment phase is expected to end
late 2024
- Target publication Q1 2026
CREDIBLE
(Cystoscopic REDuction
In BLadder Evaluations
for microhematuria) - A
randomized, controlled,
clinical utility study for
hematuria evaluation
• CU of Detect
+
• Microhematuria
• Risk stratification
- Target enrollment is 1000 subjects with an
interim analysis at 600 to determine if the
primary objective has been addressed
- Due to commence late 2024
- Target publication Q1 2028
*Dates are calendar year not financial years
Clinical Utility (CU) - Evidence a test that can usefully change patient management within the context of care for
the defined population and indication.
Clinical Validity (CV) - Evidence a test works in the same way on an independent eligible population for a given
indication.
Visit the Pacific Edge website to learn more about the strategic rationale for our studies.
PACIFIC EDGE LIMITED INVESTOR UPDATE | APRIL 2024
9

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