Publication of new clinical evidence shows significant improvements in the performance of Pacific Edge’s (ASX:PEB) genomic diagnostic acceptance for 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 announces its intent to focus further clinical evidence generation efforts on the enhanced test, Cxbladder Detect+ (CxbD+), extending.
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%).
By adding DNA biomarkers, we have developed Cxbladder Detect+, a single product for hematuria evaluation that can assist clinicians to safely and reliably rule in or rule out the presence of bladder cancer for any hematuria patient at any point in the patient care pathway,” Pacific Edge Chief Executive Dr Peter Meintjes said.
“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.
“Detect+ will require its own coding, coverage and pricing decisions to ultimately establish reimbursement however, given the increased performance it could potentially receive a higher price.
“Our existing clinical evidence generation program, specifically the company’s DRIVE study, will generate clinical validity evidence for Detect+. We will announce additional clinical validity and clinical utility studies designed specifically for Detect+ as those plans mature.”
The company will continue to explore whether DNA markers will have a similar impact on the performance of Cxbladder Monitor for recurrence of disease.
The publication, ‘Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification’, will be made available on Pacific Edge’s website as soon as it is available.