Shares of Pacific Edge Ltd (ASX: PEB) have surged by as much as 145% on Friday, attracting significant attention from investors. The small-cap stock, which is focused on cancer diagnostics, reached a high of 13.5 cents in early trading, though it has since seen some pullback and is currently up 100% at the time of writing.
The dramatic price movement follows a major development for the company: the American Urological Association (AUA) has officially included Pacific Edge’s Cxbladder Triage product as part of its standard care guidelines for managing patients with microhematuria. This endorsement marks a key milestone for the company, which expects increased demand for its Cxbladder tests in response to the guideline update.
The new AUA guidelines highlight urine-based biomarkers for evaluating intermediate-risk patients, with Cxbladder Triage being specifically mentioned as the only urine-based test backed by Grade A evidence from a randomized controlled trial. This endorsement from the AUA is expected to drive greater adoption of Cxbladder Triage as a preferred diagnostic tool in urology practices across the United States and internationally.
In addition to the guideline inclusion, Pacific Edge anticipates that the update will help strengthen its ongoing discussions with Medicare Administrative Contractor (MAC) Novitas and the Centers for Medicare & Medicaid Services (CMS). Under current legislation, MACs are obligated to consider established clinical guidelines when determining coverage for medical tests. Pacific Edge plans to leverage the AUA’s new recommendation to encourage reconsideration of its coverage decisions, potentially expanding access to Cxbladder Triage under Medicare.
Chief Medical Officer, Dr. Tamer Aboushwareb, expressed enthusiasm about the development, calling it “a significant milestone” for the company. He noted that while the AUA guideline does not mandate the use of Cxbladder Triage, it reinforces best practices within urology and is likely to support wider adoption of the test in clinical settings. Dr. Aboushwareb emphasized that the guideline’s endorsement of Cxbladder Triage, based on robust clinical evidence, will help reduce unnecessary procedures like cystoscopies for low-risk patients, leading to improved patient outcomes and greater efficiency in care delivery.
Pacific Edge’s stock rally underscores investor optimism surrounding the company’s growing footprint in the urology diagnostics market, buoyed by the credibility of the AUA’s endorsement and the potential for expanded coverage and adoption.
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