Global cancer diagnostics company Pacific Edge (NZX, ASX: PEB) welcomes the publication, in the journal 'Urology Practice', of a Kaiser Permanente study demonstrating the real-world Clinical Utility of Cxbladder Triage in the largest ever urine-based biomarker study on patients presenting with hematuria.

HERSEY, Pa., Jan. 27, 2026 /PRNewswire-PRWeb/ -- Global cancer diagnostics company Pacific Edge (NZX, ASX: PEB) welcomes the publication, in the journal 'Urology Practice', of a Kaiser Permanente study demonstrating the real-world Clinical Utility of Cxbladder Triage in the largest ever urine-based biomarker study on patients presenting with hematuria¹.

The publication, which used a 3,353-patient risk-matched cohort (n=6,706) to determine the real-world reduction in cystoscopies and imaging (CT scans), concluded that Cxbladder Triage avoided 952 cystoscopies and 70 CT scans reinforcing the previously published findings of 59% relative reduction in cystoscopies from the prospectively enrolled, randomized controlled STRATA Study².

This publication comes at an important time for Pacific Edge, because peer-reviewed publications can be considered by the Contractor Advisory Committee (CAC) that Novitas, our Medicare Administrative Contractor, will use to develop coverage language when it publishes a draft local coverage determination (LCD) that governs Medicare reimbursement for Cxbladder tests. The CAC has been tentatively scheduled by Novitas for 6pm on 19 February 2026 (US ET). Pacific Edge Chief Executive, Dr Peter Meintjes, said: "Real-world evidence from one of the largest integrated healthcare systems in the US is significant, but in this case particularly so, because the study has a sample size of 3,353 risk-match patients, unequivocally demonstrating reduction in cystoscopy at scale.

"The study reinforces the existing clinical evidence that Cxbladder Triage can safely reduce unnecessary invasive procedures for low and intermediate risk patients and help clinicians focus cystoscopies and imaging on those at higher risk."

The retrospective study considered patients evaluated according to the new clinical pathway that includes Cxbladder Triage against a risk-matched cohort of patients from the same time period that did not receive Cxbladder Triage. The primary endpoints of the study were to compare the number of cystoscopies and imaging procedures (CT scans) between the new standard of care incorporating Cxbladder Triage and the prior standard of care, while monitoring cancer detection rates. Its key findings were:

• The cystoscopy rate of patients classified by Cxbladder Triage as having a 'Low Probability' of urothelial cancer, was just 3.8%, compared with 46.5% in the risk-matched group.
• The cystoscopy rate in patients with 'High Probability' Triage scores was 73.4%, versus 45.7% in the standard-of-care group, indicating more appropriate use of invasive procedures in those most at risk.
• Overall bladder cancer detection rates between the Cxbladder Triage patients and the standard-of-care patients were similar (0.6% vs 0.7%), confirming that unnecessary procedures were reduced without compromising cancer detection.

The authors concluded: "Cxbladder Triage testing significantly decreased cystoscopy and imaging utilization among low-risk microscopic hematuria patients while simultaneously increased use among higher-risk patients. Cancer detection was consistent among patients in both groups."

Dr Meintjes said such a retrospective study and the evidence generation are uniquely available in the Kaiser Permanente system. It underscored the value of Pacific Edge's partnership with the healthcare provider and the shared commitment of both organizations to improving patient outcomes.

"The study publication provides powerful, independent confirmation of Cxbladder's value in everyday clinical practice. That is a compelling message for payers, providers, those attending the CAC in February and, most importantly, for patients who may otherwise face an invasive procedure they do not need," Dr Meintjes said.

The peer-reviewed publication can now be downloaded here.

1. Filson et al. (2026). Real-World Utility of Cxbladder Triage for Patients with Microhematuria: A Matched Cohort Study, Urology Practice (2026), doi: 10.1097/UPJ.0000000000000972.
2. Lotan et al. (2024). A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria. Journal of Urology, 211(5S), e176. https://doi.org/10.1097/01.JU.0001008576.33217.96.08.

Pacific Edge: www.pacificedgedx.com

Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way in the development and commercialization of bladder cancer diagnostic and prognostic tests for patients presenting with hematuria or surveillance of recurrent disease. Headquartered in Dunedin, New Zealand, the company provides its suite of Cxbladder tests globally through its wholly owned, and CLIA certified, laboratories in New Zealand and the USA.

Cxbladder: www.cxbladder.com

Cxbladder is a suite of non-invasive genomic urine tests optimized for the risk stratification of urothelial cancer in patients presenting with microhematuria and those being monitored for recurrent disease. The tests help improve the overall patient experience, while prioritizing time and clinical resources to optimize practice workflow and improve efficiency.

Supported by over 20 years of research, Cxbladder's evidence portfolio extends to more than 25 peer reviewed publications, and Cxbladder Triage is now included in the American Urological Association's Microhematuria Guideline. To drive increased adoption and improved patient health outcomes, Cxbladder is the focal point of numerous ongoing and planned studies designed to generate further clinical utility evidence.

Cxbladder is available in the US, Australasia, and Israel and in markets throughout Asia and South America. In the US, the test has been used by over 5,000 urologists who have ordered more than 130,000 tests. In New Zealand, Cxbladder is accessible to around 70% of the population via public healthcare and all residents have the option of buying the test online.

Media Contact
Dr Peter Meintjes, Pacific Edge, 1 (203) 947 2772, peter.meintjes@pelnz.com, www.pacificedgedx.com
Richard Inder, The Project, 64 21 645 643, richard@theproject.co.nz, https://www.theproject.co.nz/ 

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SOURCE Pacific Edge