Pacific Edge Sees 11.9% US Volume Dip Amid $21M Capital Raise

Resilience Amid Medicare Coverage Loss

Pacific Edge, a New Zealand-based cancer diagnostics company, has demonstrated notable resilience in the first quarter of fiscal 2026 despite a significant setback, the loss of Medicare coverage for its Cxbladder tests in the United States as of April 2025. The company reported an 11.9% decline in US test volumes, primarily attributed to the operational disruption caused by transitioning physicians from the older Detect test to the newer Triage test for hematuria evaluation.

However, this transition also reflects a strategic pivot. Cxbladder Triage accounted for 77% of US tests in June 2025, a sharp increase from just 22% in the previous quarter. This shift aligns with the inclusion of Triage in the American Urological Association’s (AUA) Microhematuria guideline, which has bolstered the test’s clinical credibility despite the Medicare non-coverage decision.

Clinical Evidence and Medicare Reconsideration

Pacific Edge is actively pursuing a Medicare reconsideration request with Novitas, the Medicare Administrative Contractor responsible for its US laboratory. The company has submitted new clinical evidence, including results from the STRATA randomized control study and the AUA guideline endorsement, which were not considered in the initial non-coverage decision. Early discussions with Novitas have been encouraging, with the contractor acknowledging the clinical and economic utility of Cxbladder Triage and indicating a willingness to reopen the coverage determination.

Further supporting this effort, Pacific Edge recently published analytical validation data for its next-generation test, Triage Plus, which demonstrated high sensitivity and specificity. The company anticipates Medicare coverage for Triage Plus at a higher reimbursement rate, potentially improving margins and accelerating profitability once commercialized.

Global Growth and Commercial Strategy

While US volumes faced headwinds, Pacific Edge’s Asia Pacific markets showed robust growth, with test volumes rising 8.8% across Australia, Southeast Asia, and New Zealand. This geographic diversification provides a buffer against US reimbursement challenges and underscores the company’s global reach.

Pacific Edge is also expanding its commercial payer strategy beyond Medicare, securing in-network status with key payers such as Optum Veterans’ Affairs Community Care Network and Blue Cross Blue Shield Group Purchasing Organization. These contracts aim to mitigate the impact of Medicare non-coverage and open new revenue streams.

Capital Raising to Fuel Next Phase

To sustain its commercial momentum and fund ongoing clinical studies and regulatory efforts, Pacific Edge is undertaking a $21 million capital raising. The initial placement of $16.1 million has received strong institutional support, priced at an 18% premium to recent trading levels. A subsequent $5 million Share Purchase Plan (SPP) will offer retail shareholders the opportunity to participate at the same price, contingent on shareholder approval at the upcoming Annual Shareholders Meeting in August.

This capital injection is designed to extend the company’s cash runway beyond 12 months without Medicare coverage, allowing Pacific Edge to maintain its cost base and invest in growth initiatives without compromising core priorities.

Looking Ahead

Pacific Edge’s management remains optimistic, viewing the AUA guideline inclusion as a pivotal milestone that strengthens the company’s competitive moat and supports its efforts to regain Medicare coverage. The upcoming shareholder meeting will be a critical juncture, with resolutions on the capital raise and board appointments set to shape the company’s trajectory.

As Pacific Edge navigates the complexities of reimbursement and market adoption, its focus on scalable and profitable growth will be key to unlocking shareholder value in the evolving cancer diagnostics landscape.