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: 20 January, 2026 

 

Ongoing Study Program Goal Population and Use Status
STRATA
Safe Testing of Risk for AsymptomaTic MicrohematuriA

  • CU Triage (lower risk MH) and CU Triage Plus (retrospective)

  • Microhematuria (MH)

  • Risk stratification

  • Recruitment closed with 555 patients including 223 low risk patients (test and control)

  • Interim analysis results published leading to AUA Guidelines inclusion in 2025 update
DRIVE

Detection and RIsk Stratification in VEterans Presenting with Hematuria

  • CV of Triage Plus (MH or GH)

  • Data for MH and GH pooled analysis

  • MH and gross hematuria (GH)

  • Risk stratification

  • Enrolment closed with 710 patients including 48 tumour confirmed patients from 10 US VA sites

  • Database lock completed and manuscript published

microDRIVE

Detection and RIsk Stratification in VEterans Presenting with MicroHematuria

  • CV of Triage Plus MH patients

  • MH or GH Data for pooled analysis

  • MH

  • Risk stratification

  • Study expanded to 3 active sites, 421 samples, not including protocol deviations, received to date including 16 UC confirmed (35 targeted)

  • Study design has been changed to include high risk patients presenting with GH

  • The target is 35 or more UC confirmed subjects
AUSSIE
Australian Urologic Risk Stratification of PatientS wIth HEmaturia

  • CV of Triage Plus (MH or GH)

  • Data for MH and GH pooled analysis

  • MH and GH

  • Risk stratification

  • There are 753 subjects enrolled including 55 UC confirmed (GH+MH) including 10 MH UC patients

  • Recruitment target achieved

  • Enrolment is closed, clinical database lock occurred Dec-2025, final Triage Plus data expected Jan-2026 and publication submission expected March-May 2026
Pooled Analysis

 

  • CV Triage Plus MH patients 

  • CV Triage Plus GH patients

  • MH and GH

  • Risk stratification

  • Patient data from DRIVE, AUSSIE and microDRIVE will be pooled and analyzed in two studies for MH and GH

  • MH pooled analysis is expected for submission in late 2026

  • GH pooled analysis is expected for submission in late 2026

CREDIBLE

Cystoscopic REDuction In BLadder Evaluations for microhematuria

  • CU of Triage Plus

  • MH

  • Risk stratification

  • All sites have completed contracts and IRB approvals

  • All fifteen sites now activated, 128 patients enrolled of 1000 targeted

  • Enrollment lower than expected, we will add up to 6 more sites to the study

  • Enrollment phase expected to continue until Q2 27

LOBSTER

LOngitudinal Bladder Cancer Study for Tumor Recurrence

  • CV Cxbladder Surveillance Plus (low, intermediate and high risk)

  • Surveillance

  • Risk stratification

  • Enrolment completed Q3 25 for an interim analysis — 75 UC recurrences observed (78 UCs confirmed as of 01 Dec 2025, however, only the first 75 will form the basis of the interim analysis)

  • Currently 481 subjects enrolled with 1,211 samples

  • Protocol amendment provides for continued scheduled surveillance visits and urine collections into 2027

OCTOPUS

Ongoing Cxbladder Testing for Optimized Patient Experience in Urothelial Surveillance

  • CU of Cxbladder Surveillance Plus (low, intermediate and high risk)

  • Surveillance

  • Risk stratification

  • Currently at the planning stage

  • Advisory Board completed Dec-2025

  • Business case and protocol under development

  • First patient anticipated for mid to late 2027

* 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

Cxbladder tests are designed to risk stratify patients presenting with hematuria or undergoing surveillance for recurrence of bladder cancer. A negative test result means that a patient is low risk of urothelial carcinoma (bladder cancer) and investigative cystoscopy need not be undertaken or can be rescheduled to a later date without any negative impact on patient care.

 

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

  • Establish CU for Cxbladder Triage in a microhematuria population to identify patients at low risk of bladder cancer that can safely not undertake investigative cystoscopy.
  • Retrospective analysis with the second generation Cxbladder Triage Plus test to show concordance of results with Cxbladder Triage.
  • CU evidence was pivotal to inclusion in the AUA Microhematuria 2025 Guideline update.

 

DRIVE: Prospective recruitment of patients to a single-arm observational study to demonstrate the clinical validity (CV) of Cxbladder Triage Plus in a population of Veterans presenting with hematuria.

  • Demonstrate CV of Cxbladder Triage Plus within a Veterans population supporting expansion of Guidelines indication including additional risk categories of patients with microhematura or gross hematuria.
  • Contribute data to a pooled-analysis to establish CV for Triage Plus for patients presenting with microhematuria and separately with gross hematuria.
  • CV evidence for Cxbladder Triage in microhematuria & gross hematuria patients supplementing NZ studies.

 

microDRIVE: Prospective recruitment of patients to a single-arm observational study providing CV for patients presenting with microhematuria.

  • Demonstrate the clinical validity of Cxbladder Triage Plus  in detecting urothelial cancer in patients presenting with microhematuria.
  • Contribute data to a pooled-analysis to establish CV for patients presenting with microhematuria.

 

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

  • Demonstrate CV of Cxbladder Triage Plus.
  • Contribute data to pooled analysis to establish CV for Triage Plus in patients presenting with microhematuria or gross hematuria.

 

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

  • CV of Cxbladder Triage Plus with microhematuria or gross hematuria patients.
  • Combines data from DRIVE, AUSSIE, and microDRIVE.
  • CV evidence supports AUA/NCCN guidelines inclusion using Cxbladder Triage Plus to risk stratify patients presenting with microhematuria.

 

CREDIBLE: Demonstrate the clinical utility (CU) of Triage Plus using a randomized controlled study design prospectively enrolling microhematuria patients scheduled for evaluation of microhematuria

  • Establish CU for Cxbladder Triage Plus in a microhematuria population to identify patients at low risk of bladder cancer that can safely not undertake investigative cystoscopy.

 

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

  • To safely risk stratify patients undergoing 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.
  • To support AUA/NCCN guidelines inclusion for biomarkers as an alternative to cystoscopy in a surveillance setting.

 

OCTOPUS: Demonstrate the CU of Cxbladder Surveillance Plus with low, intermediate and high-risk patients undergoing surveillance for recurrence of UC. Enrolment will be prospective using a two-arm randomized design to evaluate clinical utility.

  • Cxbladder Surveillance Plus results will be reported for patients randomized to the test arm, while patients randomized to the control arm will be under the physician prescribed standard of care.
  • Surveillance Plus low risk patients in the test arm will have their surveillance cystoscopy delayed until their next scheduled visit, while Surveillance Plus high risk patients will be scheduled for an immediate surveillance cystoscopy.
  • CU evidence will support inclusion in the AUA/NCCN guidelines.

 

  • 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.