Cxbladder Incorporated into AUA Clinical Guideline

• New AUA microhematuria guideline incorporates language for urine-based biomarkers in appropriately counseled intermediate-risk patients
• Cxbladder Triage is the only urine biomarker with 'Grade A' evidence
• Intermediate-risk patients represent an estimated 70% of those presenting with microhematuria

Pacific Edge, a cancer diagnostics company, announces that the American Urological Association (AUA) has included Cxbladder Triage as the standard of care in an amendment to its clinical guideline for the management of patients presenting with microhematuria. The guideline specifically mentions Cxbladder Triage as the only urine-based biomarker test that has 'Grade A' evidence from a randomized controlled trial (the STRATA Study) 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 that in appropriately counseled intermediate-risk patients, clinicians may offer urine cytology or validated urine-based tumor markers, including Cxbladder Triage, to facilitate the decision regarding the utility of cystoscopy. Pacific Edge anticipates an uplift in demand for Cxbladder tests as more clinicians in the US and around the world begin to observe this updated guideline and incorporate the tests into care pathways for the evaluation and management of patients presenting with microhematuria. Pacific Edge also expects to leverage the guideline language in its ongoing policy dialogue with Medicare Administrative Contractor Novitas and the Centers for Medicare and Medicaid services over the 'Genetic Testing in Oncology: Specific Tests' (L39365) local coverage determination (LCD).

Pacific Edge anticipates an uplift in demand for Cxbladder tests as more clinicians in the US and around the world begin to observe the updated AUA guideline and incorporate the tests into care pathways for the evaluation and management of patients presenting with microhematuria.

The acknowledgement of Cxbladder in the AUA guideline reinforces how Pacific Edge creates value for investors, i.e. with the continued commitment to generating the highest quality clinical evidence within a framework of AV, CV and CU, and with the appropriate end points and statistically significant sample sizes. This expertise can be repeated for Cxbladder Triage Plus, for Monitor Plus and products beyond bladder cancer.