Pacific Edge today announces the American Urological Association (AUA) has included Cxbladder Triage in an amendment to its clinical guideline for the management of patients presenting with microhematuria.
HERSEY, Pa., Feb. 28, 2025 /PRNewswire-PRWeb/ --
- New AUA microhematuria guideline incorporates language for urine-based biomarkers in appropriately counseled intermediate-risk patients
- Guideline specifically mentions Cxbladder Triage as the only urine biomarker with 'Grade A' evidence
- Intermediate-risk patients represent an estimated 70%[1] of those presenting with microhematuria
Pacific Edge today announces the American Urological Association (AUA) has included Cxbladder Triage in an amendment to its clinical guideline for the management of patients presenting with microhematuria.[2]
In a major amendment to the 2020 AUA microhematuria guideline[3], the Panel has incorporated language for the use of urine-based biomarkers for intermediate-risk patients. 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[4]) in support of this recommendation. Intermediate-risk patients represent a large cohort (estimated at 70%) of microhematuria patients, and future evidence being generated in Pacific Edge's CREDIBLE Study for the next generation test Triage Plus is designed to apply beyond the intermediate-risk hematuria patients.
The guideline states: "In appropriately counseled intermediate-risk patients who want to avoid cystoscopy and accept the risk of forgoing direct visual inspection of the bladder urothelium, clinicians may offer urine cytology or validated urine-based tumor markers (Table 5 included in this release) to facilitate the decision regarding utility of cystoscopy. Renal and bladder ultrasound should still be performed in these cases."
The AUA amendment specifically references the latest evidence generated from the STRATA Study following its publication in the Journal of Urology in May 2024. The study demonstrated in a randomized controlled trial, a first for any urine biomarker, that Cxbladder Triage could safely and effectively reduce cystoscopies by as much as 59% without missing tumors. This result paves the way for future Cxbladder products such as Cxbladder Triage Plus to be demonstrate equivalent or better performance than Cxbladder Triage for future guideline acceptance.
Pacific Edge Chief Medical Officer Dr Tamer Aboushwareb said: "The inclusion of Cxbladder Triage in the AUA guideline for the management of microhematuria is a significant milestone for Pacific Edge. While the guideline does not mandate the use of Cxbladder Triage, they are authoritative, reinforcing best practice within the urological industry and supporting greater adoption of Cxbladder in hematuria evaluation.
"Cxbladder is the only test supported by a Grade A evidence from the AUA Guideline panel and the update reflects the strength of the evidence supporting Triage and will help to reduce the burden of unnecessary cystoscopies in patients of lower risk, resulting in less patient discomfort and less morbidity, and improved access to care by reducing wait times," Dr Aboushwareb said.
Pacific Edge Chief Executive Dr Peter Meintjes said: "We are very pleased that Cxbladder Triage has been acknowledged with its inclusion in the AUA guideline. This is an outstanding result for patients across the US, and a reflection of the role genomic tests now play in the standard of care for bladder cancer patients as they have already done for prostate, breast, colon and other cancers.
"Importantly, while the AUA Guideline language is currently focused on Cxbladder Triage for intermediate-risk microhematuria patients, we now have a strong foundation for the future inclusion of Cxbladder Triage Plus for a wider range of patient types given its superior performance characteristics5. Additionally, any competing product or service will have to complete their own randomized clinical trial to establish the same Grade A evidence, fortifying our first-mover advantage."
View the amended AUA Clinical Guidelines for the Management of Microhematuria here.
View Table 5: Reported Negative Predictive Values for the Detection of Bladder Cancer Using the Available Urine Cytology and Urine-Based Biomarkers.
[1] Changes to the risk-stratification criteria for low, intermediate and high-risk categories have been made as part of the guideline update and increases the percentage of patients that are expected to be classified as intermediate risk up to 70% of the population presenting with microhematuria, according to Pacific Edge's estimate.
[2] Blood in urine that is revealed in tests, though not visible to the naked eye.
[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] 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.
[5] 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, Pacific Edge, 1 203 947 2772, [email protected], https://www.pacificedgedx.com/
Richard Index, The Project, 64 21 645 643, [email protected], https://www.theproject.co.nz/people
SOURCE Pacific Edge
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