Pacific Edge today announces it has reached more than 50% enrolment in its study to demonstrate the clinical utility of its advanced genomic biomarker Cxbladder tests in safely stratifying low-risk patients presenting with blood in urine (hematuria).

The Safe Testing of Risk for Asymptomatic Microhematuria (STRATA) study aims to further demonstrate how Cxbladder can safely risk stratify patients presenting with hematuria into those that may receive a less-intense evaluation for the presence of bladder cancer and those that should continue with a standard evaluation.

The clinical utility evidence generated by the STRATA study is expected to strengthen the case for incorporation of Cxbladder tests into the American Urological Association (AUA) guidelines and to promote more-inclusive language for the recommendation of the test, leading to increased adoption of the test into standard of care.

Cxbladder is a suite of advanced genomic biomarker diagnostic tests that are supported by a significant body of peer-reviewed clinical evidence.

In addition to helping clinicians safely de-intensify or intensify the clinical workup for patients presenting with hematuria, the tests can help resolve diagnostic dilemmas during evaluation (e.g., equivocal cystoscopy and atypical urine cytology) and monitor for the recurrence of urothelial cancer in post-treatment patients, reducing the frequency of cystoscopy required in suitable cases. Globally, more than 2,000 urologists have used Cxbladder tests to detect and monitor urothelial cancers in over 80,000 patients.

The STRATA study is a key component of Pacific Edge’s clinical evidence generation program of studies aimed at further advancing the case for the incorporation of Cxbladder into global standards of care. To date, it has enrolled 351 patients at multiple sites in the US and Canada and is seeking a further 250 as it moves towards full enrolment early in 2023.

Pacific Edge Chief Executive Dr Peter Meintjes says: “Current AUA risk stratification protocols based on clinical risk factors alone are insufficient to reliably de-intensify urological evaluation for low-risk patients. We expect the STRATA study to demonstrate how Cxbladder can satisfy this unmet need.

“At present the AUA microhematuria guideline recommends a shared patient-physician decision on whether to proceed with cystoscopy for patients classified as low-risk, a cohort that currently represents only ~5% of referred patients presenting with hematuria¹.

“We expect the STRATA study to demonstrate how Cxbladder can safely de-intensify evaluation for a significantly higher proportion of patients than the current AUA guidelines, translating to greater focus on patients with disease.”

Dr Meintjes added the company’s clinical study program, including STRATA, is a foundation of Pacific Edge’s value creation strategy. It provides the clinical utility data necessary to support wider adoption of Cxbladder by the urology community and wider reimbursement by funders and third-party payers.

Pacific Edge is targeting the publication of the STRATA study in 2023, upon completion of recruitment and study requirements.

¹ AUA Guideline and Woldu SL, Ng CK, Loo RK, Slezak JM, Jacobsen SJ, Tan WS, et al. (2021a). "Evaluation of the New American Urological Association Guidelines Risk Classification for Hematuria." J Urol 205(5): 1387-1393