New Zealand-based cancer diagnostics company Pacific Edge (ASX: PEB) has had its Cxbladder Triage test included as a standard of care by the American Urological Association (AUA).

In a major amendment to the 2020 AUA microhematuria guideline, the AUA panel has incorporated language for the use of urine-based biomarkers for intermediate-risk patients.

Most notably, it highlighted Cxbladder Triage as the only urine-based biomarker test with ‘Grade A’ evidence from a randomised controlled trial in support of this recommendation.

Authoritative finding

Pacific Edge chief medical officer Dr Tamer Aboushwareb said the company welcomed the authoritative finding, which reinforces best practice within the urological industry and the adoption of Cxbladder in hematuria evaluation.

“Cxbladder […] will help to reduce the burden of unnecessary cystoscopies in lower-risk patients, resulting in less patient discomfort, reduced morbidity and improved access to care by reducing wait times,” Dr Aboushwareb said.

He said the result paves the way for future Cxbladder products – such as the company’s next-generation Triage Plus test, which is designed for use beyond intermediate-risk hematuria patients – to demonstrate equivalent or better performance than Cxbladder Triage for future guideline acceptance.

CREDIBLE study underway

Pacific Edge’s is generating such evidence in its CREDIBLE study for Triage Plus.

The company also expects to leverage the guideline language in its ongoing policy dialogue with Medicare administrative contractor Novitas and the Centres for Medicare and Medicaid Services for a formal reconsideration of the Genetic Testing in Oncology: Specific Tests local coverage determination (LCD).

Under current legislation, Medicare contractors like Novitas must consider consensus statements and guidelines when determining coverage.

The LCD, released on 9 January 2025, threatens to end Medicare coverage of Cxbladder on 24 April.

Standard of care

Chief executive Dr Peter Meintjes was also pleased with the news that the AUA guideline had included Cxbladder Triage.

“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,” he said.

Dr Meintjes said that the decision gave Pacific Edge a strong foundation for the future inclusion of Cxbladder Triage Plus for a wider range of patient types.

“Additionally, any competing product or service will have to complete their own randomised clinical trial to establish the same Grade A evidence, fortifying our first-mover advantage,” he added.