Pacific Edge announced the acceptance for publication of new clinical evidence that shows significant improvements in the performance of its genomic diagnostic Cxbladder tests. These performance improvements were achieved by the addition of DNA biomarkers to Cxbladder Triage (CxbT) and Cxbladder Detect (CxbD), Pacific Edge's products for hematuria evaluation. Pacific Edge also announced its intent to focus further clinical evidence generation efforts on the enhanced test, Cxbladder Detect+ (CxbD+), extending Pacific Edge's first mover advantage in providing best-in-class diagnostic tools for the detection and management of bladder cancer.

The results of the study are to be published in the prestigious American Urological Association (AUA) Journal of Urology. The study enrolled 804 patients (344 from the US and 460 from Singapore), and the data shows an improvement in all performance characteristics over the existing versions of CxbT and CxbD. Notably, CxbD+ delivered Sensitivity of 97% (+23% compared with CxbD), Specificity of 90% (+8%), Negative Predictive Value of 99.7% (+2.5%), Positive Predictive Value of 44% (+19%) and Rule-out Rate of 83% (+5%).

CxbD+ was developed including a Southeast Asian patient population, further strengthening the evidence for genomic biomarker tests in genetically diverse populations, and specifically validating Cxbladder for use in Southeast Asia. Pacific Edge expects no impact to revenue from existing products - commercial Triage and Detect customers will only be transitioned to CxbD+ after reimbursement is established. The company will continue to explore whether DNA markers will have a similar impact on the performance of Cxbladder Monitor for recurrence of disease.