2024
Real World Evidence for Cxbladder to Feature at WSAUA
New data demonstrating the clinical and economic value of Pacific Edge’s Cxbladder cancer diagnostic tests will be in the spotlight at the 100th annual meeting for the Western Section of the American Urological Association (WSAUA) in Kauai, Hawaii.
Five abstracts on Cxbladder will be presented at the meeting, which runs from 27 October to 1 November 2024 and is the largest regional AUA meeting and one of the premier events in the United States’ urological calendar.
The abstracts include two independent studies: one from Southern California Permanente Medical Group (KP SoCal) on real-world evidence of Cxbladder Triage's clinical utility in assisting clinicians with hematuria evaluation, and another from the physicians at the University of Southern California highlighting Cxbladder Monitor's role in helping clinicians reduce the clinical and economic burden on cancer patients under surveillance for cancer recurrence.
Alongside these studies, Pacific Edge will present two other abstracts on the clinical value of Cxbladder Monitor: one outlining how incorporating the test into the surveillance protocol for non-muscle invasive bladder cancer (NMIBC) patients can save healthcare payers as much as US$680 per patient over five years, and another highlighting patient enthusiasm for integrating Cxbladder Monitor into their surveillance regimen. Pacific Edge conducted the economic benefits study with Germany’s Coreva Scientific, while the patient perception study was undertaken in conjunction with the non-profit bladder cancer patient advocacy organization the Bladder Cancer Advisory Network (BCAN).
Lastly, Pacific Edge will also present the protocol for its LOBSTER study, an observational study to demonstrate the clinical validity of Cxbladder Monitor and the next generation test Cxbladder Monitor+ in bladder cancer surveillance1.
Pacific Edge Chief Executive Dr Peter Meintjes said: "WSAUA offers our team a unique opportunity to engage directly with clinicians and healthcare decision-makers, helping to build a deeper understanding of Cxbladder's clinical and economic value.
"The independent studies from KP SoCal and USC, combined with our research on the economic benefits and patient enthusiasm for Cxbladder, provide compelling evidence of its impact. This evidence will complement our recently published evidence of Cxbladder Triage’s clinical utility from our STRATA2 study, the first ever randomized control trial of a urine biomarker.
“Together this evidence makes a strong case for the incorporation of Cxbladder into standards of care and for changes in healthcare payer medical and reimbursement policies that recognize the clinical value of our tests. We are looking forward to presenting this evidence at WSAUA and engaging with the delegates to advance these goals."
ABSTRACT DETAIL
(1) Real World Clinical Utility of a Urinary Biomarker (Cxbladder Triage) for Hematuria Referrals in an Integrated Managed Care Health System. (Ronald Loo, Eugene Rhee, Jeff Slezak, Southern California Permanente Medical Group)
A study involving 1,563 low-risk patients with no history of gross hematuria or those who declined cystoscopy. It showed that 1,200 or 77% of the patients assessed were able to avoid cystoscopy, boosting patient satisfaction and improving access to urological care by freeing up resources and time for other patients. Of the 363 patients flagged as high-risk, 310 underwent cystoscopy, leading to 19 confirmed cancer diagnoses (6.1% of those examined).
(2) A Real World Analysis of the Diagnostic Utility of the Cxbladder Monitor Assay. (Anosh S Dadabhoy, Farshad S Moghaddam, Leilei Xia, Siamak Daneshmand, USC Keck School of Medicine)
A study covering 99 patients to evaluate the performance of Cxbladder Monitor. The study demonstrated the test retained its high sensitivity and Negative Predictive Value (NPV) in a real-world examination. The study pointed to Cxbladder Monitor’s potential to allow for less invasive monitoring for recurrence of urothelial bladder cancer.
(3) Modeling the impact of incorporating Cxbladder Monitor in the surveillance of patients after non-muscle invasive bladder cancer in the US. (Mark Tyson, Mayo Clinic; Tobias Muench, Kim Seemann and Rhodri Saunders, Coreva Scientific; Siamak Daneshmand, Keck School of Medicine USC; Tamer Aboushwareb, Pacific Edge)
The study evaluates the cost and effectiveness of incorporating Cxbladder Monitor into the surveillance protocol for NMIBC patients, alternating with cystoscopy, the current standard of care (SoC).3 The results show that Cxbladder Monitor could reduce the total five-year surveillance costs by US$68,621 per 100 patients compared to SoC with total costs dropping from US$3,342,439 to US$3,273,818.
(4) Perception of Surveillance Cystoscopy and Genomic Urine-Based Alternatives in patients with Non-Muscle Invasive Bladder Cancer (Siamak Daneshmand, USC Keck School of Medicine; Mark Tyson, Mayo Clinic; Stephanie Chisolm, BCAN; Tamer Aboushwareb, Mike Hankey, and Andrea Cronican, Pacific Edge)
A survey of 1,507 patients being monitored for recurrent non-muscle invasive bladder cancer showed that 89% either wanted more information on urine-based testing options or would take a test if it was offered. Meanwhile, 80% rated the availability of urine-based test options as moderately to extremely important.
(5) An Observational Study of Cxbladder Monitoring for Recurrence of Urothelial Carcinoma in Low, Intermediate, and High-Risk Patients (LOBSTER) (Jonathan L. Wright, University of Washington; Florian Schroek, Geisel School of Medicine; Cesar Ercole, James A. Haley Veterans' Hospital-Tampa; Andrew Leone Bay Pines Veterans’ Affairs Healthcare System; Yair Lotan, UT Southwestern Medical Center; Werenja Ranasinge Monash University; Tony Lough and Tamer Aboushwareb, Pacific Edge)
This multi-site observational study aims to validate the performance of Pacific Edge’s Cxbladder Monitor and the second generation Monitor Plus tests in urothelial cancer surveillance. The study plans to recruit 450-500 subjects (with the goal to reach 75 confirmed tumors) from multiple medical centres. Eligible patients include those under surveillance for NMIBC who will be classified into low, intermediate, or high risk based on AUA/SUO guidelines. The study is expected to be completed in 2025 with a targeted publication date of results from the study in 2027.
[Please note that PEB has not released the information contained in this update to the NZX and ASX as it does not regard it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act.]
1 The Monitor+ assay incorporates DNA biomarkers of bladder cancer in addition to the RNA biomarkers used in the first generation Monitor test.
2 Lotan et al. (2024) A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The Safe Testing of Risk for Asymptomatic Microhematuria Trial. The Journal of Urology Vol 212 1-8 Jul 2024.
3 SoC surveillance was used for the first nine months, after which every other surveillance visit used Cxbladder Monitor as a pre-screen in patients asymptomatic for recurrence.