Pacific Edge reported a 2.7% increase in test volumes for Q4 2026 despite operational challenges, supported by growing momentum toward Medicare coverage and expanded commercial payer adoption in the US and Asia Pacific.
- Q4 2026 test volumes increased 2.7% to 5,582 tests despite sales force reductions and winter storms
- Novitas expert panel strongly supported Cxbladder tests, with draft Medicare coverage policy expected by Q2 2027
- Major US commercial payers Blue Cross Blue Shield North Carolina, South Carolina, and Highmark adopted coverage for Cxbladder tests
- Singapore General Hospital and Townsville University Hospital integrated Cxbladder tests into clinical pathways
- Pacific Edge filed a PCT patent application for its Triage Plus test combining DNA SNVs and mRNA biomarkers
Test Volumes Increase Despite Operational Challenges
Pacific Edge (NZX, ASX:PEB) reported a 2.7% rise in total laboratory throughput (TLT) for the quarter ending March 2026 (Q4 26), reaching 5,582 tests compared to 5,435 in Q3 26. The US segment saw a modest 1.0% increase to 4,064 tests, driven primarily by volume growth through the Kaiser Permanente Southern California system. The Asia Pacific region experienced a stronger 7.7% increase to 1,518 tests, supported by commercial and clinical study volumes.
This volume growth occurred despite several headwinds, including the transition of US customers from Cxbladder Detect to Triage, the absence of Medicare coverage for the product, a reduced sales force from 12.0 to 7.7 full-time equivalents (FTEs), and operational disruptions caused by winter storms. Notably, sales force efficiency improved, with tests per sales FTE rising to 530 from 335 in Q3 26, reflecting a strategic focus on profitable territories. The number of ordering clinicians decreased to 747 from 834, while tests per clinician increased to 5.4 from 4.8.
Medicare Policy Momentum Builds Following Expert Panel Endorsement
A significant development in the quarter was the strong endorsement of Cxbladder Triage by an expert panel convened by Novitas, the Medicare Administrative Contractor overseeing Pacific Edge’s Pennsylvania laboratory. The panel, which met on 19 February 2026, highlighted the unmet clinical need for urine-based biomarkers in evaluating microhematuria and gross hematuria, particularly for underserved populations such as rural patients and women.
This event typically precedes the drafting of a new or revised Local Coverage Determination (LCD) by Novitas. Pacific Edge remains confident that a positive draft LCD will be published before the end of Q2 2027, with final coverage expected approximately six months thereafter. This outlook aligns with the company’s previous assessment and follows the panel’s public transcript release in March 2026. The company’s ongoing efforts to secure Medicare reimbursement have been documented in prior updates, including the recent expert panel backing for Medicare coverage.
Expansion of Commercial Payer Coverage in the US
Pacific Edge achieved notable commercial payer milestones in the US during Q4 26. Cxbladder Triage gained coverage from Blue Cross Blue Shield (BCBS) plans in North Carolina and South Carolina, collectively covering approximately 4.2 million lives. Additionally, Highmark, a large independent BCBS licensee covering 7 million lives, adopted coverage for Cxbladder Monitor, used for surveillance of cancer recurrence.
These policy adoptions mirror coverage language from Avalon Healthcare Systems, a third-party lab benefit manager whose positive policies have influenced multiple commercial payers. Pacific Edge’s Vice President of Market Access, David Sosa, emphasised that establishing medical policy with commercial payers is a critical and complex task given the fragmented US insurance landscape. The company’s strategy prioritises engagement with large payers and lab benefit managers to build medical policy and contracting frameworks that can drive reimbursement and pricing improvements over time.
Clinical Pathway Adoption in Asia Pacific
In the Asia Pacific region, Pacific Edge marked important progress with the integration of Cxbladder tests into clinical pathways at Singapore General Hospital (SGH) and Townsville University Hospital in Queensland, Australia. SGH, the largest hospital in Singapore serving over one million patients annually, incorporated Triage, Triage Plus, and Monitor into patient care, offering eligible patients a choice between cystoscopy and Cxbladder testing. This adoption is significant as SGH is a leading tertiary hospital influencing regional clinical practice.
Townsville University Hospital, serving a population of 700,000, began clinical use of Triage Plus and Monitor for hematuria evaluation and non-muscle invasive bladder cancer surveillance. Consultant urologists at Townsville have implemented nurse-led ordering protocols, highlighting operational efficiencies and accessibility advantages of the tests.
Advancement in Intellectual Property Protection
Pacific Edge has advanced its intellectual property position by filing a Patent Cooperation Treaty (PCT) application for Cxbladder Triage Plus. This application, filed publicly in March 2026 following a confidential provisional filing in March 2025, highlights the novel combination of DNA single nucleotide variants (SNVs) with existing mRNA biomarkers and novel algorithmic analysis. The PCT filing preserves the priority date and enables streamlined patent protection efforts across multiple jurisdictions, with initial national phase entry planned in the US.
Ongoing Clinical Evidence Program Supports Future Growth
Pacific Edge continues to build its clinical evidence base through multiple studies designed to demonstrate analytical validity, clinical validity, and clinical utility of its Cxbladder tests. The AUSSIE study, which recently received the Best Oncology Presentation award at the Urological Society of Australia and New Zealand (USANZ) 2026 conference, presented preliminary data consistent with prior performance characteristics of Triage Plus. Publication of peer-reviewed results is targeted for later in 2026.
The company’s comprehensive clinical program includes several ongoing and planned studies such as STRATA, DRIVE, microDRIVE, LOBSTER, and OCTOPUS, aimed at generating robust data to support guideline inclusion and reimbursement decisions globally.
Pacific Edge Chief Executive Dr Peter Meintjes summarised the quarter by stating the company is "on the cusp of a major commercial inflection point," supported by strong clinical evidence, guideline endorsements, and growing clinical opinion momentum. The company plans to release its FY 26 financial results towards the end of May.
Bottom Line?
Pacific Edge’s Q4 volume growth and expanding payer coverage position it for potential Medicare reimbursement, though timing and commercial execution remain key uncertainties.
Questions in the middle?
- When will Novitas publish the draft Local Coverage Determination for Cxbladder Triage and Triage Plus?
- How will Pacific Edge’s reduced sales force impact longer-term test volume growth and market penetration?
- What is the anticipated timeline and commercial impact of patent approvals for the Triage Plus test?