Pacific Edge's Cxbladder Triage Test Incorporated Into AUA Microhematuria Guidelines as Only Biomarker with Grade A Evidence
Key Insights
Pacific Edge (search)'s Cxbladder Triage (search) has been incorporated into the American Urological Association (search)'s clinical guideline for microhematuria (search) management, becoming the only urine biomarker with 'Grade A' evidence.
The guideline recommends Cxbladder Triage (search) for intermediate-risk patients (estimated at 70% of microhematuria (search) cases) who wish to avoid invasive cystoscopy procedures.
Clinical evidence from the STRATA Study demonstrated Cxbladder Triage (search) could safely reduce cystoscopies by up to 59% without missing tumors, potentially increasing test demand and strengthening Medicare coverage discussions.
Pacific Edge (search) Limited announced a significant advancement for its flagship diagnostic test as the American Urological Association (search) (AUA) has incorporated Cxbladder Triage (search) into its clinical guideline for the management of microhematuria (search). The updated guideline specifically mentions Cxbladder Triage as the only urine-based biomarker with 'Grade A' evidence, establishing it as a potential standard of care option for certain patients.
The AUA's guideline amendment includes language for the use of urine-based biomarkers in appropriately counseled intermediate-risk patients, a group estimated to represent approximately 70% of those presenting with microhematuria (search) (blood in urine that is revealed in tests but not visible to the naked eye).
According to the guideline: "In appropriately counseled intermediate-risk patients who want to avoid cystoscopy and accept the risk of forgoing direct visual inspection of the bladder urothelium, clinicians may offer urine cytology or validated urine-based tumor markers to facilitate the decision regarding utility of cystoscopy. Renal and bladder ultrasound should still be performed in these cases."
Clinical Evidence Supporting the Recommendation
The AUA's recommendation is based on evidence from the STRATA Study (Safe Testing of Risk for Asymptomatic Microhematuria (search) Trial), published in the Journal of Urology in May 2024. This randomized controlled trial—the first of its kind for any urine biomarker—demonstrated that Cxbladder Triage (search) could safely and effectively reduce cystoscopies by as much as 59% without missing tumors.
Dr. Tamer Aboushwareb, Pacific Edge (search) Chief Medical Officer, emphasized the significance of this development: "The inclusion of Cxbladder Triage (search) in the AUA guideline for the management of microhematuria (search) is a significant milestone for Pacific Edge. While the guideline does not mandate the use of Cxbladder Triage, they are authoritative, reinforcing best practice within the urological industry and supporting greater adoption of Cxbladder in hematuria evaluation."
Implications for Patient Care
The guideline update has substantial implications for patient care. By potentially reducing the number of unnecessary cystoscopies—invasive procedures that can cause discomfort and anxiety—the recommendation could lead to:
- Less patient discomfort and morbidity
- Improved access to care through reduced wait times
- More efficient allocation of healthcare resources
- Enhanced patient experience during the diagnostic process
Market and Reimbursement Impact
Pacific Edge (search) anticipates an increase in demand for Cxbladder tests as more clinicians in the US and globally incorporate the updated guideline into their care pathways for evaluating and managing patients with microhematuria (search).
The guideline inclusion also strengthens Pacific Edge (search)'s position in ongoing policy discussions with Medicare Administrative Contractor Novitas (search) and the Centers for Medicare and Medicaid Services (search) regarding the 'Genetic Testing in Oncology: Specific Tests' local coverage determination (LCD). Under current legislation, Medicare Administrative Contractors are required to consider consensus statements and guidelines in determining coverage.
Dr. Peter Meintjes, Pacific Edge (search) Chief Executive, noted: "This is an outstanding result for patients across the US, and a reflection of the role genomic tests now play in the standard of care for bladder cancer (search) patients as they have already done for prostate, breast, colon and other cancers."
Future Developments
The guideline inclusion establishes a foundation for potential future inclusion of Pacific Edge (search)'s next-generation test, Cxbladder Triage Plus (search), which is designed to apply beyond intermediate-risk hematuria patients. The company is currently generating evidence through its CREDIBLE Study for Triage Plus.
Dr. Meintjes highlighted the competitive advantage this provides: "Any competing product or service will have to complete their own randomized clinical trial to establish the same Grade A evidence, fortifying our first-mover advantage."
The recognition of Cxbladder in the AUA guideline reinforces Pacific Edge (search)'s strategy of generating high-quality clinical evidence to create value for both patients and investors, with potential applications extending to other products in development, including Monitor Plus (search) and diagnostics beyond bladder cancer (search).