Pacific Edge reports a 13.4% decline in test volumes for Q3 2026 but gains strategic momentum with a key Medicare advisory meeting and clinical endorsements poised to influence reimbursement policy.
- Q3 2026 test volumes fell 13.4%, driven by a 19.5% drop in US tests
- Medicare Administrative Contractor Novitas to hold advisory committee meeting on 20 February 2026
- Kaiser Permanente study on Cxbladder Triage accepted for publication, supporting clinical utility
- Avalon Healthcare Systems endorses Cxbladder Triage for coverage, influencing 44 million US lives
- First Medicare Administrative Law Judge hearing on reimbursement appeals scheduled for 24 February 2026
Q3 2026 Performance and Market Challenges
Pacific Edge, the New Zealand-based cancer diagnostics company, has reported a 13.4% decline in total laboratory test volumes for the third quarter of fiscal 2026, with 5,446 tests processed compared to 6,286 in the previous quarter. The US market, which represents the majority of volumes, saw a sharper 19.5% drop to 4,003 tests, reflecting ongoing challenges related to Medicare non-coverage and the seasonal holiday slowdown. Conversely, the Asia-Pacific region experienced a 9.7% increase in test volumes, buoyed by commercial payer growth.
Strategic Medicare Engagements Gain Traction
Despite subdued volumes, Pacific Edge is advancing its long-term strategic objective to secure enduring Medicare coverage for its flagship Cxbladder tests. A pivotal moment is approaching with the Medicare Administrative Contractor Novitas convening a Contractor Advisory Committee (CAC) meeting on 20 February 2026. This meeting is expected to shape a draft Local Coverage Determination (LCD), which would provide clearer reimbursement policy and potentially reverse the non-coverage stance established in early 2025.
The CAC meeting will feature expert clinicians, including urologists familiar with Cxbladder, and will review new clinical evidence and guideline updates, notably the inclusion of Cxbladder Triage in the American Urological Association’s 2025 Microhematuria Guideline. The company anticipates a trading halt around the meeting to manage market sensitivity.
Robust Clinical Evidence Supports Coverage Case
Pacific Edge’s case for Medicare coverage is strengthened by recent clinical milestones. A Kaiser Permanente real-world evidence study demonstrating the clinical utility of Cxbladder Triage has been accepted for publication in the journal Urology Practice, adding significant weight to the company’s evidence portfolio. Additionally, Avalon Healthcare Systems, a major diagnostic intelligence provider influencing reimbursement decisions for over 44 million US lives, has endorsed Cxbladder Triage as meeting coverage criteria. This endorsement, alongside a positive rating from the Emergency Care Research Institute, bolsters Pacific Edge’s position with both Medicare and commercial payers.
Medicare Appeals and Leadership Transition
In parallel with policy efforts, Pacific Edge is pursuing appeals for Medicare reimbursement denials. The first hearing before an Administrative Law Judge (ALJ) is scheduled for 24 February 2026, shortly after the CAC meeting. Success in these appeals could set a precedent for over 1,650 denied tests, potentially impacting revenue for fiscal years 2026 and 2027.
On the governance front, the company welcomed Simon Flood as its new Chair in December 2025, succeeding Chris Gallaher who retired after nine years. Flood brings extensive global capital markets and governance experience, signalling a steady hand as Pacific Edge navigates this critical phase.
Looking Ahead
Pacific Edge enters 2026 with a clear focus on securing Medicare coverage through the LCD process, which would provide reimbursement certainty and likely stimulate demand for Cxbladder tests. While test volumes remain pressured by current non-coverage and market transitions, the company’s strategic and clinical progress positions it well for a potential turnaround in the US market.
Bottom Line?
The February Medicare meetings and appeals will be pivotal in defining Pacific Edge’s reimbursement future and market trajectory.
Questions in the middle?
- Will the Novitas advisory committee recommend positive coverage language for Cxbladder in the draft LCD?
- How will the Administrative Law Judge ruling on Medicare appeals influence broader reimbursement policies?
- Can Pacific Edge leverage commercial payer endorsements to offset Medicare coverage challenges in the near term?