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: 10th July, 2024 


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

  • CU for Detect+ (retrospective)

  • Microhematuria

  • Risk stratification

  • First paper published in the Journal of Urology in May 2024 and presented at the AUA annual conference

  • Study sites will close late 2024 and final study reports completed early 2025


Detection and RIsk Stratification in VEterans Presenting with Hematuria

  • CV for Detect+, Detect & Triage within a Veterans’ cohort

  • Data for pooled analysis

  • Micro and gross hematuria

  • Risk stratification

  • Enrolment closed with 710 patients across 10 Veterans Affairs sites

  • Data cleanup underway and Detect+ runs expected Q3 2024

  • Publication targeted for Q2 2025


Detection and RIsk Stratification in VEterans Presenting with MicroHematuria

  • CV of Detect+

  • Data for pooled analysis

  • Microhematuria

  • Detection

  • Recruitment commenced November 2023 as a network study across all US Veterans Affairs Medical Centers coordinated from a single Veterans Affairs site

  • 208 patients have been consented for the study with 102 samples received to date

  • The target is up to 1,000 patients including 35 tumor confirmed patients

  • Enrolment end is targeted for early 2025 and publication Q3 2025

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 September 2023

  • 98 subjects are consented to the study and 93 samples have been received

  • 2 sites enrolling and 1 further site expected to commence within a month

  • Target publication Q4 2025

Pooled Analysis


  • CV of Detect+

  • Microhematuria

  • Gross Hematuria

  • Risk stratification

  • Microhematuria and separately Gross Hematuria patients from DRIVE, AUSSIE and microDRIVE will be pooled and performance determined

  • Target publication Q1 2026


LOngitudinal Bladder Cancer Study for Tumor Recurrence

  • CV of Monitor/ Monitor+

  • Surveillance

  • Risk stratification

  • Target enrolment is 400-500 subjects across 10 sites (US, Australia)

  • A total of 321 subjects have consented to the study with 532 samples received

  • The enrolment phase is expected to end early 2025

  • Target publication Q1 2026


Cystoscopic REDuction In BLadder Evaluations for microhematuria

  • CU of Detect+ 

  • Microhematuria

  • Risk stratification

  • Target enrolment is 1,000 subjects with an interim analysis at 600 to determine

  • if the primary objective has been addressed
    First patient in targeted for Dec 2024

  • 15 US sites anticipated

  • Target publication Q1 2028

* 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 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 and Detect+ test in risk stratifying Veterans presenting with hematuria

  • Demonstrate CV of Cxbladder Detect and 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.



  • 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 (Detectpositive) and AUA low risk (Detectnegative).


  • 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.