Draft LCD Proposes Medicare Coverage for Triage and Triage

15 May 2026
DRAFT LCD PROPOSES MEDICARE COVERAGE FOR TRIAGE AND
TRIAGE PLUS
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX/ASX: PEB) today
notes that a draft Local Coverage Determination (LCD) with foundational medical policy for
urine-based biomarkers for hematuria evaluation (DL40378) has been published to the
Medicare Coverage Database, with explicit coding guidance for Cxbladder Triage and Triage
Plus in the associated Local Coverage Article (LCA) (DA60424).
The draft LCD ‘Urine-based Biomarkers in Patients with Microhematuria’ (DL40378)
establishes hematuria evaluation as a covered Medicare benefit for the first time and
importantly distinguishes hematuria patients as eligible for Cxbladder Triage and Triage Plus
when contrasted with the existing non-coverage LCD ‘Genetic Testing in Oncology: Specific
Tests’ which is for a different patient population, i.e. ‘patients with cancer or substantiated
suspicion of cancer’.
In the rationale section of the draft LCD, Novitas states: “Given the low prevalence of
malignancy in patients with MH
1
, the limited diagnostic performance of urine cytology and
earlier generation UBBs
1
, and the emerging body of evidence supporting select multi-analyte
rule-out assays, limited coverage for UBB testing is supported when applied within a narrowly
defined clinical context. Specifically, use of validated multi-analyte UBBs may be reasonable
and necessary to support risk-stratification in appropriately counseled, intermediate-risk
patients with MH who are considering deferral of cystoscopy.”
Importantly, the associated draft article for billing and coding guidance (DA60424) makes clear
that both Cxbladder Triage (0363U) and Cxbladder Triage Plus (0420U) are proposed to be
reimbursable under this policy. No other urine-based biomarkers are included in the draft
coding article creating a moat around our microhematuria business.
Pacific Edge Chief Executive Dr Peter Meintjes said: “This new draft LCD establishes
hematuria evaluation as a covered Medicare benefit for the first time. The draft language clearly
distinguishes microhematuria patients as eligible for urine-biomarker testing and notes positive
coverage for Cxbladder Triage and Triage Plus. This result reflects the substantial body of
clinical evidence Pacific Edge has developed in recent years and the clinical needs described
by the panel of experts assembled by Novitas for its recent CAC Meeting
2
.
“We welcome Novitas’ decision to expediently address our reconsideration requests and those
of the AUA
3
and other clinicians. This is an excellent outcome for Medicare patients, urologists,

1
MH means Microhematuria and UBB means Urine-based Biomarkers
2
Novitas convened a panel of experts for a Contractor Advisory Committee (CAC) Meeting on 19 February, 2026
to consider the evidence for urine-based biomarkers in the evaluation of hematuria
3
AUA is the American Urological Association

2

and the broader healthcare system, supporting access to appropriate care while balancing
clinical and economic considerations.
“The draft LCD and LCA confirm our position as the first mover and market leader in non-
invasive diagnostics for microhematuria patients suspected of bladder cancer, and Pacific
Edge now stands on the cusp of a major commercial inflection point with the only two tests
covered for microhematuria evaluation.
“Importantly, as Triage Plus has been included in the draft coverage language, we have the
opportunity to shift our customers over to i) a test with higher clinical utility, ii) a test that works
on a broader range of patient types, iii) a test that continues to have a cost benefit for healthcare
systems and payers, and iv) a test that shifts the economics of Pacific Edge towards operating
profitably given the Medicare price of US$1,328 per test, a 75% improvement over the US$760
received for the legacy Cxbladder products,” Dr Meintjes said.
While an LCD, when finalized, directly enables reimbursement for over 66 million Medicare
patients, the clarity in draft coverage language provides a template for US commercial payers
to adopt in their own medical policies for the 223 million US lives they collectively insure. The
Company also expects this news to provide a tailwind to the adoption of our tests in
international markets.
Publishing the draft LCD marks the beginning of a well-defined process governed by the
Medicare Program Integrity Manual
4
. This begins with a ‘Notice and Comment’ period of a
minimum of 45 days during which Novitas
5
will hold a public meeting and accept written
comments. Within 12 months from today, Novitas must address the comments and publish a
final version of the LCD or withdraw the draft LCD. If it finalizes the draft LCD, it will become
effective 45 days after it is published.
“Noting the strength of the underlying clinical evidence, the alignment to AUA guidelines and
the clinical opinion expressed on the CAC, Pacific Edge looks forward to Novitas addressing
comments and publishing the final LCD,” Dr Meintjes said.
“Given this draft LCD clearly distinguishes microhematuria patients as covered and as distinct
from cancer patients in the non-coverage LCD (L39365), Pacific Edge will engage with Novitas
to seek reimbursement for Triage and Triage Plus on a claim-by-claim basis during the draft
period.”
Dr Meintjes said the language in the draft LCD reflects the strength of Pacific Edge’s value
creation strategy that is founded on generating the compelling clinical evidence required to
drive behavior change in physicians.

4
The Medicare Program Integrity Manual (MPIM) can be downloaded at:
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c13.pdf
5
Novitas is the Medicare Administrative Contractor (MAC) with jurisdiction over Pacific Edge’s laboratory in
Pennsylvania

3

“We produce evidence that is founded on the frameworks of AV, CV, CU
6
, on defined patient
populations, with statistically significant sample sizes and measuring the appropriate endpoints
that drive change in medical policy. Creating value for investors through evidence development
is a core expertise that Pacific Edge can repeat for Cxbladder Triage Plus, for Surveillance
Plus and future products beyond bladder cancer.”
Pacific Edge notes that its retail offer to eligible existing shareholders to raise up to NZ$6
million, with the ability to accept oversubscriptions at Pacific Edge’s discretion (Retail Offer),
opened on Thursday, 14 May 2026 and closes at 5:00pm NZST on Thursday, 28 May 2026.
The Retail Offer is open to “Eligible Shareholders”, who are all persons recorded on Pacific
Edge’s share register at 7:00pm NZST on Friday, 8 May 2026 as being a holder of Pacific Edge
shares and having an address in New Zealand.
The Retail Offer follows Pacific Edge’s successful placement (the Placement) of NZ$25.4
million of new ordinary shares to certain investors at a price of NZ$0.17 per share, which closed
on Tuesday, 12 May 2026. Over 90% of the shares to be issued under the Placement will be
issued to existing Pacific Edge shareholders, who were prioritized in the Placement.
Eligible Shareholders who wish to participate in the Retail Offer are able to apply for up to a
maximum of NZ$50,000 of new shares per shareholder at NZ$0.17 per share, the same price
per share offered to investors under the Placement. Further information on the Retail Offer,
including the Retail Offer Document that contains the terms and conditions of the Retail Offer,
and information on how to apply for shares under the Retail Offer, is available at www.nzx.com
and www.asx.com.au under ticker code “PEB”.
The draft LCD Urine-based Biomarkers in Patients with Microhematuria (DL40378) can be
accessed via the following link: https://www.cms.gov/medicare-coverage-
database/view/lcd.aspx?lcdid=40377
The draft LCA Billing and Coding: Urine-based Biomarkers in Patients with Microhematuria
(DL60424) can be accessed via the following link: https://www.cms.gov/medicare-coverage-
database/view/article.aspx?articleId=60423
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

6
Analytical Validity (AV), Clinical Validity (CV), and Clinical Utility (CU),

4

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 suite of non-invasive genomic urine tests optimized for the risk stratification of
urothelial cancer in patients presenting with hematuria and those being monitored for recurrent
disease. The tests help improve the overall patient experience, while prioritizing time and
clinical resources to optimize practice workflow and improve efficiency.
Supported by over 20 years of research, Cxbladder’s evidence portfolio extends to more than
twenty-five peer reviewed publications, and Cxbladder Triage is now included in the American
Urological Association’s Microhematuria Guideline. To drive increased adoption and improved
patient health outcomes, Cxbladder is the focal point of numerous ongoing and planned studies
designed to generate further clinical utility evidence.
Cxbladder is available in the US, Australasia, and Israel and in markets throughout Asia and
South America. In the US, the test has been used by over 5,000 urologists who have ordered
more than 130,000 tests. In New Zealand, Cxbladder is accessible to around 70% of the
population via public healthcare and all residents have the option of buying the test online.