Pacific Edge reports a 9% decline in Cxbladder test volumes amid Medicare coverage loss but gains momentum with new clinical validation and a CMS pricing boost.
- Q2 2026 test volumes down 9% due to Medicare coverage loss and test migration
- DRIVE Study published confirming clinical validity of Cxbladder Triage Plus
- Novitas to convene expert panel in February 2026 on urine biomarker evidence
- CMS recommends 75% higher reimbursement rate for Triage Plus
- Pacific Edge completes $20.7 million capital raise to support US operations
Operational Challenges Amid Medicare Coverage Loss
Pacific Edge, the New Zealand-based cancer diagnostics company, has reported a 9% decline in total Cxbladder test volumes in the three months ending September 2025. The drop to 6,286 tests from 6,905 in the previous quarter is largely attributed to the loss of Medicare coverage in the US and the transition of customers from the Detect test to the newer Triage and Triage Plus tests.
The US market, which accounts for the majority of Pacific Edge’s volume, saw a sharper 13.1% decline, while volumes in the Asia-Pacific region rose 11.2%, driven by clinical study activity. The company also noted a reduction in ordering clinicians and a leaner sales force, which has improved sales efficiency but reflects the challenges of selling non-covered products amid increased administrative burdens.
Clinical Validation and Medicare Appeal Momentum
Despite these operational headwinds, Pacific Edge has made significant strides in clinical validation and reimbursement efforts. The DRIVE Study, which validates the clinical performance of Cxbladder Triage Plus in a veterans’ population, was accepted for publication in the Journal of Urologic Oncology. This milestone provides critical evidence to support Pacific Edge’s formal request for Medicare coverage of Triage Plus.
Further, Novitas, the Medicare Administrative Contractor, has announced plans to convene a Contractor Advisory Committee in February 2026 to review the evidence for urine-based biomarkers in microhematuria patients. This panel signals recognition of the updated American Urological Association guidelines and the strength of Pacific Edge’s clinical data, potentially paving the way for revised coverage policies.
Pricing Boost and Strategic Financial Positioning
Adding to the positive outlook, the US Centers for Medicare & Medicaid Services (CMS) has recommended a reimbursement rate of US$1,328 for Cxbladder Triage Plus. This represents a substantial 75% increase over the current US$760 rate for existing tests, enhancing the commercial viability of the product once coverage is secured.
To support ongoing operations and clinical programs during this challenging period, Pacific Edge successfully raised $20.7 million in new equity capital. The company emphasizes disciplined capital management and sales force productivity as priorities moving forward.
Leadership Transition and Future Outlook
In leadership news, Pacific Edge’s US President, David Levison, is stepping down after nearly a decade with the company. His tenure saw significant growth in test volumes and revenue. The company is now searching for a Chief Commercial Officer to lead sales, marketing, and market access functions in the US, signaling a strategic focus on commercial execution.
While the Medicare appeals process is slow and the timing of coverage decisions remains uncertain, Pacific Edge is optimistic about the eventual recognition of its tests’ clinical value. The company expects revenue contributions from successful appeals in the second half of the financial year and continues to engage with regulators and professional societies to advance its position.
Bottom Line?
Pacific Edge’s path to Medicare coverage remains complex but promising, with clinical validation and pricing advances setting the stage for a potential turnaround in US market momentum.
Questions in the middle?
- Will the February 2026 Novitas expert panel lead to a favorable Medicare coverage decision?
- How quickly can Pacific Edge scale US sales once Triage Plus gains coverage and higher reimbursement?
- What impact will the leadership change have on Pacific Edge’s US commercial strategy?