Recognition of Cxbladder's clinical and economic value in evaluating patients presenting with hematuria is set to gain momentum at the American Urological Association's (AUA) Annual Meeting, April 26–29 in Las Vegas.
HERSEY, Pa., April 23, 2025 /PRNewswire-PRWeb/ -- Recognition of Cxbladder's clinical and economic value in evaluating patients presenting with hematuria is set to gain momentum at the American Urological Association's (AUA) Annual Meeting, April 26–29 in Las Vegas.
A plenary session at the meeting will highlight Cxbladder Triage's inclusion in the AUA's new microhematuria guideline released in February 2025. Additional sessions will cover a large real-world study by Kaiser Permanente[1] confirming the clinical utility of Triage, and preliminary results[2] from the DRIVE study focused on the clinical validation of Triage Plus. These sessions are a significant opportunity for Pacific Edge to deepen market understanding of Cxbladder's performance and drive its broader clinical adoption.
Pacific Edge Chief Executive Dr Peter Meintjes said: "Guideline amendments are always significant talking points at an AUA meeting. However, with urine biomarkers getting their first positive inclusion language in the microhematuria guideline[3] and Cxbladder Triage being the first and only biomarker to receive a 'Grade A'[4] evidence, this year is bigger than most, and the plenary session provides a great platform for how Pacific Edge is improving the standard of patient care.
"The Kaiser Permanente study is important because it demonstrates the real-world impact of Cxbladder Triage with tremendous statistical power given the sample size of 3,353 patients. The design of the study prospectively managed hematuria patients according to the new Triage-based standard of care and then retrospectively compared those clinical outcomes to a cohort of "risk-matched" patients from Kaiser Permanente nation-wide EMR who did not. This kind of study and evidence generation is uniquely available in the Kaiser Permanente system and underscores the value of our partnership and our shared commitment to improving patient outcomes.
"The DRIVE study will be presented in the Urological Society of American Veterans (USAV) session at the AUA to showcase preliminary clinical validity results for Triage Plus for the evaluation of hematuria in a Veterans population. These data are important for establishing a local coverage determination for Triage Plus with Novitas, and as validation for the US Veterans Administration to consider incorporating Cxbladder into its facilities."
Further detail on the AUA 2025 sessions is below:
Key Milestone: Cxbladder Triage Incorporated into AUA Microhematuria Guideline
The highlight for Pacific Edge and Cxbladder will be the Plenary: Afternoon Session (Saturday April 26, 1:20–1:50 PM) where leading urologists will discuss the new AUA Microhematuria Guideline, which for the first time incorporated language for the use of urine-based biomarkers for intermediate-risk patients.
The new guideline says urologists may use urine-based biomarkers for appropriately counseled intermediate-risk patients presenting with microhematuria to assist their decision on whether to defer a cystoscopy. It specifically mentions Cxbladder Triage as the only urine-based biomarker test that has 'Grade A' evidence from a randomized controlled trial — the STRATA Study[5], which demonstrated the test can reduce cystoscopies by up to 59% without compromising tumor detection.
The session will be led by Vanderbilt University Medical Center Professor Daniel Barocas, Mayo Clinic Professor of Urology Stephen Boorjian — who are both members of the guideline panel — as well as University of Virginia Professor of Urology Tracy Downs and University of North Carolina, Chapel Hill, Associate Professor of Urology & Co-Director Urologic Oncology Mary Westerman.
Kaiser Permanente Real-World Data Validates Cxbladder's Clinical Utility and Safety
A second key presentation at the meeting will be delivered during the Bladder Cancer: Epidemiology & Evaluation I session (Saturday, April 26, 1:00–3:00 PM). The study by Kaiser Permanente Southern California reinforced existing evidence on the Clinical Utility of Cxbladder Triage, in safely reducing patients presenting with hematuria from unnecessary cystoscopies.
The retrospective study compared the new clinical pathway that includes evaluation of microhematuria patients with Cxbladder Triage to inform the decision to offer the patient a cystoscopy and imaging. It matched 3,353 Kaiser patients that received Triage, with an equal number of patients with similar risk that received the prior standard of care without Cxbladder Triage. The primary endpoints were to compare the number of cystoscopies and imaging procedures between the new standard of care incorporating Triage and the prior standard of care that did not.
The study found:
- In patients with 'Low Probability' Triage scores, the cystoscopy rate was 3.8% versus 46.5% in the standard of care patients.
- In patients with 'High Probability' Triage scores, the cystoscopy rate was 73.4% versus 45.7% in the standard of care patients.
- The overall bladder cancer detection rate between the Triage patients and the standard of care patients was similar.
The authors of the study concluded: "These data reveal that Cxbladder Triage testing resulted in significantly decreased cystoscopy and imaging utilization in those classified as low risk without any negative patient outcomes, while simultaneously demonstrating increases in the cystoscopy and bladder cancer detection rate in the physician directed protocol group."
The DRIVE Study Expands Evidence Base for Cxbladder Triage Plus
The Clinical Validation of Cxbladder Triage Plus[6] in a Veterans population will be presented at the Urological Society for American Veterans meeting on Monday, April 28 (7:30 AM–12:00 PM) by one of the study's investigators Dr Kyoko Sakamoto of the San Diego VA medical center.
The DRIVE Study (Detection and Risk Stratification In Veterans Presenting with Hematuria) evaluated the prognostic performance of Cxbladder Triage Plus compared to cystoscopy. It showed that Triage Plus demonstrated similarly high-performance characteristics in the veterans' population when compared with the proof-of-concept study by Lotan et al. in 2022[7].
The authors of the study concluded: "Cxbladder Triage Plus demonstrated clinical validity in this VA 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 Cxbladder Team looks forward to speaking with all of those clinicians who are planning to attend AUA 2025 and invites them to visit the Cxbladder booth (#2239). For any questions in the lead up to the event, please contact the Team at [email protected].
[1] Loo R.K., et al (2025) Clinical Utility of a Urine Biomarker (Cxbladder Triage) Compared to a Standard of Care for Microscopic Hematuria Evaluations in a Large Independent Delivery Network. Abstract submitted to the AUA 2025 meeting.
[2] Savage S.J., et al (2025) The Prognostic Performance of Cxbladder Triage Plus for the Identification and Priority Evaluation of Veterans at Risk for Urothelial Carcinoma: The Drive Study, Abstract submitted to the AUA 2025 meeting.
[3] Barocas DA, Lotan Y, Matulewicz RS, Raman JD, Westerman ME, Kirkby E, Pak L, Souter L. Updates to Microhematuria: AUA/SUFU Guideline (2025). J Urol. doi: 10.1097/JU.0000000000004490.
[4] The AUA defines 'Grade A' evidence as evidence with a high certainty rating and notes evidence of this grade makes it "very confident that the true effect lies close to that of the estimate of the effect."
[5] 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.
[6] Cxbladder Triage Plus is a next generation Cxbladder UBTM test that combines an analysis of mRNA and DNA markers to further improve clinical utility and efficiency. As a single test for hematuria evaluation, Triage Plus is optimized for the risk stratification of patients presenting with microhematuria. Timing for the launch of Cxbladder Triage Plus in countries across the Asia Pacific Region is to be confirmed. For more information, please contact us at [email protected].
[7] Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. The Journal of Urology, 10-1097.
Media Contact
Peter Meintjes (CEO), Pacific Edge, 1 203 947 2772, [email protected], https://www.pacificedgedx.com/
SOURCE Cxbladder’s clinical
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