Highlights

  • Novitas CAC meeting scheduled for 20 February 2026, ahead of potential Medicare policy development.
  • Kaiser Permanente real-world evidence study accepted for publication in Urology Practice.
  • APAC laboratory test volumes increased 9.7% quarter-on-quarter, offsetting lower US volumes.

Cancer diagnostics company, Pacific Edge Limited (NZX:PEB) has released its investor update for the three months ended December 2025 (Q3 FY26), outlining progress across Medicare engagement, clinical evidence development, laboratory testing volumes, and governance. The update centres on activities supporting potential reinstatement of US Medicare coverage for its Cxbladder tests, alongside regional testing performance and upcoming regulatory milestones.

Medicare Advisory Committee in Focus

A central feature of the update is a preview of the upcoming Medicare Administrative Contractor (MAC) Novitas Contractor Advisory Committee (CAC) meeting, scheduled for 20 February 2026 at 12.00pm NZST. The CAC process typically precedes the development or revision of medical policy through a draft Local Coverage Determination (LCD).

Pacific Edge provided guidance on areas investors may monitor during the meeting, as outcomes may inform future policy settings relating to diagnostic coverage. Evidence presented at the CAC may contribute to discussions around clinical utility and eligibility for reimbursement under Medicare.

Clinical Evidence Gains Visibility

Pacific Edge reported that Kaiser Permanente’s real-world evidence study evaluating the clinical utility of Cxbladder Triage has been accepted for publication in Urology Practice. Acceptance allows the study to be referenced publicly and increases the likelihood it can be profiled during the CAC meeting.

The study was initially previewed at the 2025 American Urological Association annual meeting and focuses on real-world application of Cxbladder Triage in clinical settings.

Medicare Appeals Process Advances

The company also outlined progress in its Medicare appeals relating to Cxbladder Triage tests denied reimbursement following finalisation of the Genetic Testing for Oncology LCD: Specific Tests (L39365), which ended coverage of Cxbladder.

Pacific Edge confirmed that the first hearing, covering four cases, has been scheduled for 24 February 2026, shortly after the CAC meeting. Additional appeals remain in progress.

Laboratory Testing Volumes by Region

Total laboratory throughput (TLT) for Q3 FY26 declined 13.4% to 5,446 tests, compared with 6,286 tests in Q2 FY26. US volumes decreased 19.5% to 4,003 tests from 4,971 in the prior quarter.

In contrast, APAC volumes increased 9.7% to 1,443 tests from 1,315, supported by higher commercial testing activity in the region.

Payer Endorsement and Board Transition

Pacific Edge confirmed that Cxbladder Triage has been endorsed as “meeting coverage criteria” by Avalon Healthcare Systems, a diagnostic intelligence provider supporting healthcare payers and providers covering more than 44 million lives in the US. This endorsement adds to the body of evidence available for payer and policy discussions.

The update also acknowledged the retirement of Chair Chris Gallaher and introduced Simon Flood as the company’s new Chair.

Company Snapshot

Pacific Edge Limited is headquartered in Dunedin, New Zealand, and operates globally in bladder cancer diagnostics. The company delivers its Cxbladder test portfolio through wholly owned, CLIA-certified laboratories in New Zealand and the United States.

Pacific Edge shares closed at NZD 0.18 on 20 January, with a reported gain of 205.00% over the past 12 months.