MEDICARE COVERAGE FOR TRIAGE AND 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)1
• 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 noncovered
• 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 2 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 todays 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:
Dr Peter Meintjes
Chief Executive
P: +64 22 032 1263

Media:
Richard Inder
The Project
P: +64 21 645 643

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.