Cxbladder Triage may help patients avoid unnecessary cystoscopies

Use of the Cxbladder Triage test appears to significantly decrease utilization of cystoscopy and imaging in patients who are identified as low risk, according to data presented at the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada.¹

Christopher Filson, MD, MS

The results were presented by Christopher Filson, MD, MS, a urologist at Kaiser Permanente in Los Angeles, California.

According to the investigators, Cxbladder Triage “uses mRNA biomarkers and clinical information to classify a patient’s risk of having bladder cancer.” Kaiser Permanente – Southern California (KP-SCAL) utilizes a validated Hematuria Risk Index (the standard of care [SOC]) to guide both the use of cystoscopy as well as type of imaging modality. For the study at AUA 2025, the investigators sought to evaluate “real-world utility of adding the Cxbladder Triage test to the standard KP-SCAL microscopic hematuria diagnostic workflow.”

Patients were included in the study if they had a urinalysis with microscopic hematuria, had an encounter with a urologist between September 2021 and September 2024, were between 38 and 88 years of age, and had 6 months of membership with Kaiser Permanente before and after the encounter. Patients were excluded if they had gross hematuria within 6 months prior to the encounter or had a prior diagnosis of bladder cancer. The investigators identified patients who underwent testing with Cxbladder Triage and created a 1:1 matched cohort of non-tested patients based on the date of the encounter and hematuria risk index.

Based on their Cxbladder Triage test result, patients were divided into 2 groups: low probability of bladder cancer (<4.00) and physician-directed protocol (≥4.00). Outcomes of interest for the study included cystoscopy within 6 months, CT urography within 6 months, and bladder cancer diagnosis within 6 months and 1 year.

“Of 5242 patients who received the Cxbladder Triage test, 3,353 (64%) were included for analysis and matched 1:1 with SOC patients,” the investigators wrote. Mean age (standard deviation) was 61.3 (12.4) years in the Cxbladder Triage arm and 62.1 (12.9) years in the SOC arm. More than half of patients were female in both cohorts.

The investigators reported that 2670 patients had a low probability score in the Cxbladder Triage and SOC groups, and that 683 patients had physician-directed protocol. The 6-month CT urogram rate was 7.5% (201 patients) in the low probability patients receiving CxBladder Triage and 11.7% (313 patients) in the low probability patients receiving SOC. The 6-month CT urogram rate was 19.5% (133 patients) in the physician-directed protocol patients receiving Cxbladder Triage and 13.3% (91 patients) in the physician-directed protocol patients receiving SOC. The 6-month bladder cancer rate was 0.1% (3 patients) in the low probability patients receiving Cxbladder Triage and 0.7% (19 patients) in the low probability patients receiving SOC. The 6-month bladder cancer rate was 2.5% (17 patients) in the physician-directed protocol patients receiving Cxbladder Triage and 0.6% (4 patients) in the physician-directed protocol receiving SOC. The 1-year bladder cancer rate was 0.1% (3 patients) in the low probability patients receiving Cxbladder Triage and 0.7% (19 patients) in the low probability patients receiving SOC. The 1-year bladder cancer rate was 2.6% (18 patients) in the physician-directed protocol patients receiving CxBladder Triage and 0.7% (5 patients) in the physician-directed protocol receiving SOC.

All told, the study population was able to avoid 952 cystoscopies and 70 CT scans, according to the investigators.

“Cxbladder Triage testing significantly decreased cystoscopy and imaging utilization among low-risk microscopic hematuria patients while simultaneously increased use among higher-risk patients. Further population-level evaluations of the Cxbladder Triage test are warranted to reduce the burden of unnecessary cystoscopy,” the investigators wrote in their poster.

In a news release about the study, Pacific Edge Chief Executive Peter Meintjes, PhD, said, “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 3353 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.”²

AUA 2025 also featured discussion of the organization’s recent microhematuria guideline, which “specifically mentions Cxbladder Triage as the only urine-based biomarker test that has ‘Grade A’ evidence from a randomized controlled trial — the STRATA Study,³ which demonstrated the test can reduce cystoscopies by up to 59% without compromising tumor detection,”according to the news release.²

REFERENCES

1. Filson C, Loo RK, Slezak JM, Jhaveri J, Aboushwareb T, et al. Clinical utility of a urinary biomarker (Cxbladder Triage) compared to standard of care for microscopic hematuria evaluations in a large independent delivery network. 2025;213(5S):e246. doi:10.1097/01.JU.0001109788.99555.df.11

2. Cxbladder's clinical utility in focus at AUA 2025. News release. Pacific Edge. April 23, 2025. Accessed April 28, 2025. https://www.pacificedgedx.com/news-and-events/news/2025/cxbladders-clinical-utility-in-focus-at-aua-2025/

3. Lotan Y, Daneshmand S, Shore N, et al. A multicenter prospective randomized controlled trial comparing cxbladder triage to cystoscopy in patients with microhematuria: the safe testing of risk for asymptomatic microhematuria trial. 2024;212(1):41-51. doi:10.1097/JU.0000000000003991