Medicare Coverage for Triage & Triage Plus Confirmed

6 November 2026
MEDICARE COVERAGE FOR TRIAGE & TRIAGE PLUS CONFIRMED

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX/ASX: PEB) notes
that the final Local Coverage Determination (LCD) for urine-based biomarkers in patients with
microhematuria has been published to the Medicare Coverage Database, confirming Medicare
coverage for Cxbladder Triage and Triage Plus.
The final LCD, 'Urine-based Biomarkers in Patients with Microhematuria' (L40378), establishes
hematuria evaluation as a covered Medicare benefit and provides foundational medical policy
for the use of validated urine-based biomarkers in the evaluation of intermediate risk
microhematuria patients. The final LCD is scheduled to become effective in 45 days on 20
December 2026.
Key Points:
• Cxbladder Triage and Triage Plus are confirmed as covered for intermediate risk
microhematuria patients (~1.14 million testing opportunities per year)
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• Pacific Edge extends its market leading position with only Cxbladder Triage and Triage
Plus covered by the final LCD; competing tests and generic billing codes are non-
covered
• Medicare coverage removes logistical and reimbursement objections for urologists who
may have been reluctant to order a test without established Medicare coverage
• Medicare reimbursement for Triage and Triage Plus meaningfully increases the
average selling price (ASP) supporting revenue growth and operating leverage,
particularly after Triage and Monitor were recently re-priced under PAMA
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at
US$1057/test and US$1026/test with Triage Plus priced at US$1,328/test
• Pacific Edge expects Medicare Advantage payers to reliably reimburse for Triage and
Triage Plus in accordance with Medicare policy boosting cashflow generation for the
business
• Pacific Edge expects to leverage Medicare coverage with Commercial Payers to drive
policy adoption and improve commercial payer appeals and associated revenues
The final LCD substantially resembles the draft LCD published in May 2026. Consequently,
the key focus for Pacific Edge remains to migrate all hematuria evaluation testing to Triage
Plus ($US1,328/test), focus on intermediate-risk patients, which are disproportionately female,
implement clinical pathways at integrated delivery networks and improve ASP through
commercial payer activities. Adding to the commercial payers already covering Cxbladder
tests, Geisinger (owned by Kaiser Permanente) recently established commercial policy for all-
risk microhematuria patients, taking the number of commercially contracted lives for our
hematuria tests to 12.9 million in addition to those covered by Medicare. We expect today’s

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Management estimate
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PAMA: Protecting Access to Medicare Act

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coverage decision to unlock further commercial payer policy and contracts over the coming
quarters.
Pacific Edge Chief Executive Dr Peter Meintjes said: “The final LCD is a significant milestone
for Pacific Edge, Medicare patients, urologists, and the broader healthcare system. It provides
clear guidance on the eligible hematuria patients for which Triage and Triage Plus should be
reimbursed and recognizes the important role that validated, non-invasive urine-based
biomarkers can play in helping physicians make better-informed decisions about cystoscopy.
“The LCD confirms Pacific Edge as the market leader, with only Triage and Triage Plus tests
covered under the policy. This leadership is a consequence of its commitment to generating
the overwhelming evidence needed to change physician behavior, medical policy, and
guidelines.”
The final LCD directly enables reimbursement for eligible Medicare patients, with Medicare
covering more than 71 million lives in the US. Pacific Edge also expects the final policy to
provide an important reference point for US commercial payers, which collectively insure
approximately 223 million lives, as they consider their own medical policies for urine-based
biomarkers in microhematuria evaluation and the price that they are willing to pay for the test.
Dr Meintjes concluded: “To ensure that we are well positioned to capitalize on the opportunity
presented by the LCD, we are making selective investments in our commercial team and digital
technologies to support commercial and laboratory operations and strengthen our competitive
position in the hematuria market.”
The final LCD “Urine-based Biomarkers in Patients with Microhematuria” (L40378) can be
accessed via the following link:
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=40378
The final LCA for billing and coding (L60424) can be accessed via the following link:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=60424
The response to comments article (L60570) can be accessed via the following link:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=60570
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: +64 22 032 1263

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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.