Clinical Trials

Clinical Trials

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 


Ongoing Study Program Enrolled Sites & Locations Progress & Targets*
Safe Testing of Risk for AsymptomaTic MicrohematuriA
11/13 USA and Canada
  • Enrolment total is 468, including 122 'low risk' subjects (with 400 and 105 of these subjects eligible, respectively) that are the focus of the study
  • Target ~600 subjects, including 120 low risk subjects randomized to test arm
  • Last patient in Q2 2023
  • Follow up until Q2 2024

Detection and RIsk Stratification in VEterans Presenting with Hematuria

8/11 (VA) USA
  • Enrolment total is 551
  • Target (Q2 2025) -700 patients
  • Last patient in: Q2 2023
  • Follow up: until Q3 2025


Detection and RIsk Stratification in VEterans Presenting with MicroHematuria

0/0 USA
  • Projected to start recruitment Sept/ Oct 2023
  • Target is 1,000 patients
  • Last patient in: March/ April 2024
Australian Urologic Risk Stratification of PatientS wIth HEmaturia
1/1 Australia
  • Contract fully executed Mar 2023
  • Enrolment due to start in Q2 2023
  • Last patient in Q2 2025

DEtection of Disease in the Upper TraCT

  • Now to be transferred to an investigator-initiated study

LOngitudinal Bladder Cancer Study for Tumor REcurRence

  • Three sites are open and another 8 are at pre-activation. Enrolment is now 63 patients
  • Each site will enrol 100 patients within 12 months and follow up for another 12 months

MONitoring Study of Post-Treatment Effectiveness for Residual Disease

0/1 New Zealand 

  • Finalizing protocol documentation and commenced engagement with ethics committee
  • Business case for this study currently in development by R&D

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

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.