Clinical Trials

Clinical Trials

Our clinical study program is a key pillar of how Pacific Edge drives value. We are focused on generating the compelling clinical evidence required to drive behavior change in physicians. Specifically, we seek to produce evidence that is founded on the frameworks of Analytical Validity (AV), Clinical Validity (CV), and Clinical Utility (CU), with the endpoints and sample sizes required for coverage decisions and guideline inclusion.

Status of Studies Within Our Clinical Trials Program

Last updated: 14 July, 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

  • Final analysis publication is being developed and will confirm published findings
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 or GH)

  • MH or GH Data for pooled analysis

  • MH and GH

  • Risk stratification

  • Last patient enrolled is achieved with 35 UC confirmed subjects, final subject data to be collected is expected in Jul-26, final monitoring by Aug-26, database lock in Sep-26 and publication early 2027

  • Publication provides opportunity to publish a pooled analysis validating Triage Plus with MH patients from microDRIVE, DRIVE and AUSSIE studies
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 757 subjects enrolled including 56 UC confirmed (GH+MH) including 10 MH UC patients

  • Publication is projected for Q3 2026
Pooled Analysis

 

  • CV Triage Plus (MH & GH) pooled analysis

  • MH and GH

  • Risk stratification

  • MH patient data from DRIVE, AUSSIE & microDRIVE will be analysed with publication expected Q1-2027

  • Separately GH patient data and demographic data will be analysed with publication expected in early 2027

CREDIBLE

Cystoscopic REDuction In BLadder Evaluations for microhematuria

  • CU of Triage Plus

  • MH

  • Risk stratification

  • Currently 247 patients are enrolled of 1000 targeted

  • Enrolment is lower than expected and we will close unproductive sites and open new sites to the study

  • Enrolment phase expected to continue until Q2 to Q3 2027

LOBSTER

LOngitudinal Bladder Cancer Study for Tumor Recurrence

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

  • Surveillance

  • Risk stratification

  • Enrolment completed (Q4-25) having achieved our target of 75 confirmed recurrences

  • Data monitoring is expected to continue providing for an interim analysis Dec-26

  • Currently there are 448 subjects enrolled with 1314 samples

  • Sample collection at scheduled surveillance visits will continue through to Oct-27

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 and protocol synopsis developed. There will be no further progress until a business case is approved

* 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.