Clinical evidence fundamentally underpins commercial success in healthcare and consequently is one of the key pillars of our investment program. High-quality clinical evidence is needed by clinicians to make the decision to adopt Cxbladder in clinical practice and by healthcare payors to make decisions to cover and reimburse a Cxbladder test. The guidelines committees of professional medical societies, including the American Urological Association (AUA), the National Comprehensive Cancer Network (NCCN) and the European Association of Urology (EAU), also rely on this evidence to support embedding Cxbladder as a standard of care.

Status of Studies Within Our Clinical Trials Program

Last updated: 14 July, 2025 

* Dates are calendar years, not financial years
** Pacific Edge's IRB-approved clinical trials are listed at clinicaltrials.gov

¹ This figure is smaller than the figure provided in the company’s 2025 annual report due to a revision subsequent  to its publication on 30 June 2025.

The Strategic Rationale For Each Study

Cxbladder tests are designed to risk stratify patients presenting with hematuria or undergoing surveillance for recurrence of bladder cancer. A negative test result means that a patient is low risk of urothelial carcinoma (bladder cancer) and investigative cystoscopy need not be undertaken or can be rescheduled to a later date without any negative impact on patient care.

STRATA: Demonstrate the clinical utility (CU) of Cxbladder Triage using a prospective, two-arm randomized design to risk-stratify patients and rule out investigative cystoscopy.

• Establish CU for Cxbladder Triage in a microhematuria population to identify patients at low risk of bladder cancer that can safely not undertake investigative cystoscopy.
• Retrospective analysis with Cxbladder Triage Plus to show concordance of results for the second-generation test in microhematuria populations with the improved performance characteristics.
• CU evidence supports AUA/NCCN guidelines inclusion using Cxbladder Triage.

DRIVE: Prospective recruitment of patients to a single-arm observational study to demonstrate the CV of Cxbladder Triage Plus in a population of Veterans presenting with hematuria.

• Demonstrate CV of Cxbladder Triage Plus within a Veterans population supporting AUA/NCCN Guidelines inclusion in microhematuria & gross hematuria patients.
• Contribute data to a pooled-analysis to establish CV for Triage Plus for patients presenting with microhematuria.
• CV evidence for Cxbladder Triage in microhematuria & gross hematuria patients supplementing NZ studies.

microDRIVE: Prospective recruitment of patients to a single-arm observational study providing CV for patients presenting with microhematuria.

• Demonstrate the clinical validity of Cxbladder Triage Plus  in detecting urothelial cancer in patients presenting with microhematuria.
• Contribute data to a pooled-analysis to establish CV for patients presenting with microhematuria.

AUSSIE: Prospective recruitment of patients to a single-arm observational study providing CV in an Australian healthcare setting for patients presenting with hematuria.

• Demonstrate CV of Cxbladder Triage Plus.
• Contribute data to meta-analysis to establish CV for Triage Plus in microhematuria patients.

Microhematuria Pooled Analysis: Pooled-analysis of Cxbladder Triage Plus performance from multiple studies involving prospectively recruited patients from single-arm observational studies including eligible microhematuria patients.

• CV of Cxbladder Triage Plus with microhematuria patients.
• Combines data from DRIVE, AUSSIE, and microDRIVE.
• CV evidence supports AUA/NCCN guidelines inclusion using Cxbladder Triage Plus to risk stratify patients presenting with microhematuria.

LOBSTER: Prospective recruitment of patients to a single-arm observational study to evaluate the clinical validity of Cxbladder Monitor/Monitor Plus.

• To safely risk stratify patients under surveillance for recurrence of urothelial cancer (UC).
• To demonstrate that it is safe to alternate Cxbladder Monitor with cystoscopy for intermediate and high-risk patients under surveillance for recurrence of UC.
• Targeting AUA/NCCN guidelines inclusion for biomarkers as an alternative to cystoscopy in a surveillance setting.

CREDIBLE: Demonstrate the clinical utility (CU) of Triage Plus using a randomized controlled study design prospectively enrolling microhematuria patients scheduled for evaluation of said hematuria

• Will compare cystoscopy use for patients in the control arm risk stratified by AUA Standard of Care guidelines into high, intermediate and low risk with patients in the test arm risk stratified by Cxbladder Detect and managed as AUA high risk (Triage Plus positive) and AUA low risk (Triage Plus negative)