Cxbladder Detect+ Now Named Cxbladder Triage Plus

Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today announces it has adopted the brand name Cxbladder Triage Plus for its next generation urine-biomarker test.

Triage Plus supersedes the working brand name of the test, Cxbladder Detect+. Pacific Edge has adopted the new name because it better reflects the clinical positioning of the new test in helping clinicians to triage patients presenting with hematuria¹.

Triage Plus combines the value propositions of the existing Triage and the Detect tests in a single assay. Its high negative predictive value and sensitivity means a negative test can help clinicians rule out the presence of cancer in patients presenting with hematuria, the largest market opportunity for the test. Meanwhile, its high specificity and positive predictive value, means a positive test can assist clinicians to resolve diagnostic dilemmas as well as focus on the highest risk patients for a more intensive workup.

The Triage Plus name also positions the test to benefit from the existing and future evidence portfolio. Specifically, the STRATA² study, now published in the American Urological Association’s (AUA) Journal of Urology, and real-world evidence that is being developed by the Southern California Permanente Medical Group (KP SoCal) have strengthened the clinical utility evidence for Cxbladder Triage in helping clinicians to safely rule out the presence of bladder cancer.

Data from the KP SoCal study was presented in an abstract³ to the Western Section of the AUA Annual Conference at the end of October and we are working with the healthcare provider in a data partnership for publication as real-world evidence.

Furthermore, as the AUA undertakes its update to the microhematuria guidelines, Triage as the focal point in the STRATA study, is best positioned to benefit from any potential favorable product-specific language in the guideline.

Finally, the change to Triage Plus aligns with the company’s long-term strategic goal to move the test into the primary care setting, allowing clinicians to use the test ahead of a referral to specialist urological care. 

Pacific Edge Chief Executive Dr Peter Meintjes said: “Among the urological community there is a growing recognition that improvements in the risk stratification – or triage – of patients presenting with hematuria can reduce the risk of patient morbidity and discomfort, improve patient access to specialist care and ease the economic burden of unnecessary urological examinations.

“Adopting the Triage name strengthens the communication of the clinical value to risk stratify hematuria patients as we seek to drive commercial adoption of Cxbladder among clinicians and patients. Coupled with the accumulation of clinical evidence supporting the use of Cxbladder Triage, this name change is expected to assist our reimbursement efforts with healthcare payers and incorporation into international standards of care.”

Notes to Editors

STRATA is the first ever randomized control trial of a urine biomarker and therefore the first study to deliver evidence of the standard typically required for a guidelines committee to consider changes to standards of care. The study showed clinicians undertook 59% fewer cystoscopies, when provided a Cxbladder Triage test result.

The KP SoCal abstract focuses on 1,563 low-risk patients in the Kaiser Southern California health system with no history of gross hematuria or who refused cystoscopy. It showed 1,200 patients, or 77% of the patients in the study, safely avoided invasive cystoscopy, improving patient satisfaction, urology access and lowering the overall cost of care.

Updated logo

In anticipation of the launch of Triage Plus in 2025, Pacific Edge has modernized its logo to align our company positioning with our Cxbladder product brand. Updated logo assets in both a primary horizontal orientation and secondary vertical orientation can be downloaded from this Dropbox folder across a range of formats. Going forward, we ask that you use these across your documents and digital platforms where applicable.

¹ Pacific Edge may continue to use the Detect+ name in certain formal documents as necessary, and will seek to amend the proprietary test name for CPT Code 0420U to Triage Plus through the quarterly administrative process with CMS.

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 Real World Clinical Utility of a Urinary Biomarker (Cxbladder Triage) for Hematuria Referrals in an Integrated Managed Care Health System. Abstract accepted for presentation to the Western Section of the American Urological Association annual conference.