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: 9th Apr, 2024 

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

The Strategic Rationale For Each Study

Our clinical studies are principally aimed at delivering two types of evidence: clinical validity (CV) evidence (evidence that Cxbladder accurately identifies a patient’s clinical status in an independent patient cohort) and clinical utility (CU) evidence (evidence that Cxbladder is clinically useful for patients and physicians in a defined population and indication). We are also undertaking studies to deliver analytical validity (AV) evidence (evidence that a test result is reproducible in laboratory conditions).

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

• Establish CU for Cxbladder Triage in microhematuria populations to identify patients at low risk of bladder cancer that can safely avoid cystoscopy.
• Retrospective analysis with Cxbladder Detect⁺ to show theoretical CU for the second-generation test in microhematuria populations with the improved performance characteristics.
• CU evidence supports AUA/NCCN guidelines inclusion using Cxbladder Triage and sets the stage for Cxbladder Detect⁺ to risk stratify microhematuria populations.

DRIVE: Prospective recruitment of patients to a single-arm observational study to demonstrate the CV of Cxbladder Detect⁺ test in risk stratifying Veterans presenting with hematuria

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

microDRIVE: 

• Demonstrate the clinical validity of Cxbladder Detect⁺ in detecting urothelial cancer in patients presenting with microhematuria.
• MicroDRIVE will compare the performance of Detect⁺ against the current gold-standard for the detection of urothelial cancer, diagnostic cystoscopy and pathology.
• Contribute data to pooled-analysis to establish CV for Detect⁺ in microhematuria patients.

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

• Demonstrate CV of Cxbladder Detect⁺ with an Australian cohort.
• Demonstrate accurate risk stratification of hematuria patients to intensify or de-intensify evaluation.
• Contribute data to meta-analysis to establish CV for Detect⁺ in microhematuria patients.

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

• CV of Cxbladder Detect⁺ with microhematuria patients.
• Combines data from DRIVE, AUSSIE, and MicroDRIVE. CV evidence supports AUA/NCCN guidelines inclusion using Cxbladder Detect⁺ to risk stratify microhematuria populations.

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

• 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 Detect⁺ 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 (Detect⁺ positive) and AUA low risk (Detect⁺ negative).