Clinical Value of Cxbladder to Feature at UAA 2025

New clinical evidence demonstrating Cxbladder’s clinical value in hematuria evaluation and surveillance – including reducing unnecessary procedures and better outcomes for patients - is set to be presented at the 22nd Urological Association of Asia Congress in Taipei, Taiwan, 14-17 August.

UAA is the largest event on the Asia Pacific urological calendar, attracting several thousand urologists and medical professionals from across the region. Cxbladder will feature in several presentations during the event, with new clinical studies and real-world evidence taking center stage.

Taking the podium, Pacific Edge Chief Executive Dr. Peter Meintjes will present findings from the DRIVE Study – a study undertaken in the US supporting the Clinical Validation of our next generation Cxbladder test Triage Plus¹. As a single test for hematuria evaluation with enhanced performance through the addition of DNA markers, Triage Plus is designed to better risk stratify patients, reducing the need for further invasive testing in those with a low probability of urothelial cancer (UC).

The Clinical Validation of Triage Plus will be further supported with a presentation of the AUSSIE Study – a multi-site Australian trial, led by study author Dr. Varun Buhariwalla. New Zealand urologist Dr. Giovanni Losco will then reinforce the clinical utility of Cxbladder as a frontline diagnostic with real-world data from New Zealand, a 2024 audit of Cxbladder Detect and Cxbladder Triage performance within the Canterbury Hematuria Pathway.

Supporting the use of the Cxbladder suite in a surveillance setting, the design and status of the multi-site LOBSTER trial is set to feature in a presentation by Dr. Kylie Yen-Yi Lim. LOBSTER is currently being undertaken in Australia and the US, and is intended to evaluate the performance of Cxbladder Monitor and Cxbladder Monitor Plus² in the surveillance of patients with non-muscle invasive bladder cancer (NMIBC) for recurrence of disease. Alongside this, a potential role for Cxbladder Triage Plus in the annual surveillance of UC in patients with Lynch Syndrome in the absence of hematuria will be evidenced by findings from a recent New Zealand study, led by Dr. Andrew-Kennedy-Smith.

Pacific Edge will host its first Distributor Meeting before the official start of the conference, bringing together its regional network for the first time to share successes, discuss challenges and focus on driving adoption across the region.

Dr. Meintjes commented, “We are excited by the growth prospects in the broader APAC region through our distributor network, our digital marketing efforts and our in-market sales team. Although ‘send-out’ testing is a barrier in some geographies, this is an excellent way to develop the market, familiarize the physicians with the value of Cxbladder and how to interpret the results to improve the standard of care. Long-term the APAC market is an ideal candidate for our plans to develop and commercialize in-vitro diagnostic (IVD) products.”

Further detail on our UAA 2025 sessions is included below.

The Diagnostic Performance of Cxbladder Triage Plus for the Identification and Priority Evaluation of Veterans at Risk for Urothelial Carcinoma: The DRIVE Study

Fri Aug 15, 15:48-15:54pm CST, ID: 451

The Clinical Validation of Cxbladder Triage Plus in a US Veterans population will be presented by Pacific Edge Chief Executive Dr. Peter Meintjes.

The DRIVE Study (Detection and Risk Stratification In Veterans Presenting with Hematuria) evaluated the performance of Cxbladder Triage Plus when compared to cystoscopy combined with histopathologic confirmation of UC. It showed that Triage Plus demonstrated similar high-performance characteristics in the veterans’ population when compared with the proof-of-concept study by Lotan et al. in 2022³.

The authors of the study concluded: “Cxbladder Triage Plus demonstrated clinical validity in this Veterans population with gross hematuria or microhematuria, with high sensitivity and specificity. These findings indicate that Triage Plus may be safely used to rule out or detect [urothelial cancer] in patients with hematuria.”

The DRIVE is study expected to be published in October 2025.

The Australian Urologic Risk Stratification of Patients With Hematuria (AUSSIE) Study of Cxbladder Performance for the Detection of Urothelial Carcinoma in Patients With Hematuria: Trial in Progress

Fri Aug 15, 16:00-16:06pm CST, ID: 515

The design of a second study clinically validating the performance of Cxbladder Triage Plus in an Australian cohort - The Australian Urologic Risk Stratification of Patients with Hematuria trial (AUSSIE) - will be presented by one of the study’s authors Dr. Varun Buhariwalla⁴.

The AUSSIE study, an active prospective trial being conducted across multiple Australian sites, aims to enrol 800 patients presenting with hematuria. Cxbladder Triage Plus is designed to risk stratify patients and de-intensify work-up for patients risk stratified as low probability of UC. The performance of Cxbladder Triage Plus will be compared to cystoscopy and histopathologic confirmation of UC.

Enrolment is expected by close August 2025 with publication targeted for March-April 2026. Primary endpoints for the study include sensitivity, specificity, NPV, PPV, and test-negative rate⁵.

Evaluating the Performance of Cxbladder Triage and Detect and Imaging for the Detection of Urothelial Cancer in Patients with Gross Hematuria: A Canterbury, New Zealand Audit

Fri Aug 15, 15:36-15:42pm CST, ID: 420

Further supporting the utility of the Cxbladder suite in hematuria evaluation, Dr. Giovanni Losco⁶ will be present performance data from a retrospective audit of 500 patients presenting with gross hematuria in 2024 as part of the Cxbladder supported Canterbury Hematuria Pathway in New Zealand.

In line with the Pathway protocol, patients presenting with hematuria within the study were evaluated using Cxbladder Triage, Cxbladder Detect and imaging (CT-IVU or ultrasound). The study found:

• When used alone, Cxbladder Triage showed 100% sensitivity, 100% NPV, and a test-negative rate of 27%.
• When used alone, Cxbladder Detect achieved 85% sensitivity, 98% NPV, and a 64% test-negative rate. Combining use with imaging increased sensitivity to 97%.
• Cxbladder testing outperformed imaging alone (which demonstrated 71% sensitivity) in detecting UC.
• Cxbladder Detect combined with imaging was recommended as the preferred pathway for evaluation of gross hematuria.

The Longitudinal Bladder Cancer Study for Tumour Recurrence (LOBSTER) Study of Cxbladder Monitor and Monitor Plus for Recurrence of Urothelial Carcinoma in Low, Intermediate, and High-Risk Patients: Trial in Progress

Fri Aug 15, 15:54-16:00pm CST, ID: 464

Shifting the focus to surveillance, clinical study author Dr. Kylie Yen-Yi Lim⁷ will discuss the design of the LOBSTER trial. LOBSTER is an active multi-national longitudinal study evaluating the performance of Cxbladder Monitor and Cxbladder Monitor Plus in the surveillance of NMIBC.

The LOBSTER study aims to recruit 700 patients across Australia and the US, with enrolment expected to conclude in late 2025. Key endpoints include sensitivity, specificity, NPV, PPV, and test-negative rate.

Optimizing Urothelial Carcinoma Surveillance in Patients with Lynch Syndrome: A Role for Annual Cxbladder Testing?

Thurs Aug 14, 14:24-14:28pm CST, ID: 1073 (Moderated Poster)

Further supporting the utility of Cxbladder in surveillance, Dr. Andrew Kennedy-Smith8 will present findings from a New Zealand study evaluating a role for annual Cxbladder testing in the surveillance of UC in patients with Lynch Syndrome (LS). Current surveillance strategies in this setting (urinalysis, cytology, CT urography, and cystoscopy) suffer from low sensitivity, a high burden on the patient and health system, and poor patient compliance with scheduled checks. The study hypotheses that annual Cxbladder Triage Plus testing, a non-invasive test option with 94% sensitivity and 99.3% NPV in prior validation may be an option for improved surveillance of LS.

Findings from the study, supported with strong patient compliance with scheduled checks, led the authors to recommend Cxbladder as a front-line tool in LS surveillance protocols to enhance early detection and reduce the need for invasive testing.

Further information on UAA 2025 can be found here. We look forward to speaking with all of those clinicians who are planning to attend and invite you to visit us at booth #37. If you have any questions leading up to the event, please contact your Cxbladder representative or email us at info@cxbladder.com.

¹ Cxbladder Triage Plus is scheduled for an Asia Pacific launch in early 2026. For more information, please contact us at info@cxbladder.com.

² Cxbladder Monfitor Plus is a next generation Cxbladder test for the surveillance of patients being monitored for recurrent NMIBC. Timing for the launch of Monitor Plus is still to be confirmed.

³ Lotan et al. (2023). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. Journal of Urology, 209(4), 762–772.

⁴ Dr Varun Buhariwalla is a Urology Research Fellow working at Austin Health in Melbourne, Australia, with a focus on bladder cancer and digitization and optimization of theatre operating processes.

⁵ Negative predictive value (NPV); positive predictive value (PPV).

⁶ Giovanni Losco FRACS, MB BCh. Clinical Director - Urology, Health New Zealand Te Whatu Ora Waitaha Canterbury, Christchurch Hospital. Chair, NZ Urology Clinical Directors’ Group. Director, Urology Associates.

⁷ Dr. Kylie Yen-Yi (Yen) Lim MBBS BMed. Dr. Lim is a practicing urology registrar at Monash Health in Melbourne, Australia.

⁸ Andrew Kennedy-Smith FRACS, MB BCh. Andrew is a full-time consultant urologist at Wellington Hospital, New Zealand.