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: 12th Oct, 2023 


Ongoing Study Program Goal Population and Use Status
Safe Testing of Risk for AsymptomaTic MicrohematuriA
  • CU for Triage

  • CU for Detect+ (retrospecitive)

  • Microhematuria

  • Risk stratification

  • Enrolment is now closed with a total of 554 including 131 low risk patients. Follow up with continue until Q3 2024

  • Data monitoring is underway and expected to be completed Q1 2024


Detection and RIsk Stratification in VEterans Presenting with Hematuria

  • CV for Detect+

  • CV for Triage and within a Veterans’ cohort

  • Data for pooled analysis

  • Micro and gross hematuria

  • Risk stratification

  • Enrolment total is 648 across 11 US sites and in line with target.

  • Enrolment is expected to close late 2023 with follow up continuing until Q2 2024


Detection and RIsk Stratification in VEterans Presenting with MicroHematuria

  • CV of Detect+

  • Data for pooled analysis

  • Microhematuria

  • Detection

  • Projected to start recruitment Oct 2023 as a network study across al VAMCs coordinated from a single US VA site

  • Target is 1000 patients and 50 tumor confirmed

  • Last patient in: March/April 2024

Australian Urologic Risk Stratification of PatientS wIth HEmaturia
  • CV of Detectwith an Australian cohort

  • Data for pooled analysis

  • Micro and gross hematuria

  • Risk stratification

  • Target enrolment: 600 patients across three Australian sites

  • Enrolment commenced August 2023 and 7 subjects are enrolled to date

Pooled Analysis


  • CV of Detect+

  • Microhematuria

  • Risk stratification

  • Microhematuria patients from DRIVE, AUSSIE, STRATA and microDRIVE will be pooled and performance determined

  • The projected analysis is Q3-2025


LOngitudinal Bladder Cancer Study for Tumor Recurrence

  • CV of Monitor/ Monitor+

  • Surveillance

  • Risk stratification

  • Target enrollment is 426 subjects across 10 sites (US, Australia)

  • Enrolment is now 126 subjects


Cystoscopic REDuction In BLadder Evaluations for microhematuria

  • CU of Detect+ 

  • Microhematuria

  • Risk stratification

  • Target enrollment is 1000 subjects with an interim analysis at 600 to determine if the primary objective has been addressed

  • Due to commence late 2024

* 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 (MH) 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 MH populations with the improved performance characteristics
  • CU evidence supports AUA/NCCN guidelines inclusion using Cxbladder Triage and/or Cxbladder Detect+ to risk stratify MH populations


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

  • CV evidence for Cxbladder Triage in microhematuria (MH) & gross hematuria (GH) patients supplementing NZ Studies
  • Demonstrate CV of Cxbladder Detect+ within a Veterans cohort
  • Retrospective analysis with Cxbladder Detect+ to demonstrate CV evidence supporting AUA/NCCN Guidelines inclusion in MH & GH patients
  • Contribute data to pooled-analysis to establish CV for Detect+ in MH patients



  • 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


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 (MH) patients

  • CV of Cxbladder Detect+ with MH patients
  • Combines data from DRIVE, AUSSIE and a future MH-focused clinical trial
  • CV evidence supports AUA/NCCN guidelines inclusion using Cxbladder Detect+ to risk stratify MH populations


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

  • To safely risk stratify patients under surveillance for recurrence of urothelial carcinoma (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 low risk patients scheduled for evaluation of hematuria

  • Will compare 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).


  • Analytical Validity (AV): Develop a test that is repeatable in the lab for a given indication and population.
  • Clinical Validity (CV): Make sure the test works in the same way on an independent eligible population for the given indication.
  • Clinical Utility (CU): Put the test in the hands of a physician to establish that it can usefully change patient management within the context of care for the defined population and indication.