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: 19 October, 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, will confirm published findings and is expected in 2027
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

  • Final monitoring is complete for 667 consented patients including 36 confirmed with urothelial carcinoma

  • Database lock was achieved Sep-2026 with data analysis to follow in Oct

  • Publication is targeted for Q1-2027
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 691 evaluable subjects enrolled including 54 confirmed bladder tumor patients (10 MH UC; 43 GH UC; 1 adenocarcinoma)

  • Accepted for publication
Pooled Analysis

 

  • CV Triage Plus (MH & GH) pooled analysis

  • MH and GH

  • Risk stratification

  • MH patient data from DRIVE, AUSSIE & microDRIVE from 1053 patients will be analysed with publication expected Q2-2027

  • Separately GH patient data from 762 patients will be analysed with publication expected Q2-2027

CREDIBLE

Cystoscopic REDuction In BLadder Evaluations for microhematuria

  • CU of Triage Plus

  • MH

  • Risk stratification

  • Currently 335 patients are enrolled of 1000 targeted

  • Enrollment 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

  • Currently there are 448 subjects enrolled with approximately 1336 samples

  • Enrolment was completed Q4-25 having achieved our enrolment target of 75 confirmed urothelial carcinoma recurrences (99 patients had at least one recurrence)

  • Data monitoring is expected to continue until April-2027 with full database lock targeted for May-2027

  • Sample collection will continue with

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.

* 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.