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: 18th Apr, 2023 

* 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 physicians for a defined population and indication). We are also undertaking studies to deliver analytical validity (AV) evidence (evidence that a test is repeatable in laboratory conditions).

STRATA: Demonstrate the clinical utility (CU) of Cxbladder 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 equivalent or greater CU in microhematuria populations with the improved performance characteristics
• CU evidence supports AUA/NCCN guidelines inclusion using Cxbladder Triage and/or Cxbladder Detect⁺ to risk stratify microhematuria populations

microDRIVE: Prospective recruitment of patients to a single-arm observational study to demonstrate the CV of Cxbladder tests to risk stratify Veterans presenting with microhematuria

• CV evidence for Detect+ and Triage (secondary objective) in microhematuria patients supplementing US and Australian Studies
• Demonstrate CV of Cxbladder Detect⁺ within a Veterans cohort
• Contribute data to meta-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

DEDUCT: Prospective recruitment of patients to a single-arm observational study to validate performance of Cxbladder Detect⁺ for the detection of urothelial carcinoma (UC) in the upper tract (UTUC)

• CV of Cxbladder Detect⁺ for the detection of UTUC
• To safely risk stratify patients suspected to have UTUC and avoid unnecessary ureteroscopy and radiation exposure through imaging
• Targeting inclusion of Cxbladder utility for UTUC in AUA/NCCN guidelines

LOBSTER: Prospective recruitment of patients to a single-arm observational study to evaluate the clinical validity of CxbM

• To safely risk stratify patients under surveillance for recurrence of UC
• To demonstrate that it is safe to alternate CxbM 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

MONSTER: Single-arm, observational study to validate the performance characteristics of Cxbladder against white light cystoscopy during surveillance of UC

• Christchurch study to measure residual disease
• To safely risk stratify patients for residual disease prior to the 6-week re-resection for high grade patients or the 3-month flexible cystoscopy check for all patients

Investigator Initiated Trials (Selected Studies Only)

Coming soon.