Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients.

Current American Urological Association (AUA) guidelines mandate a risk-stratified approach for the evaluation of microhematuria. Urine genomic tests with high negative predictive value could further reduce unnecessary diagnostic testing and morbidity, but the economic impact is unknown.

This study modeled the financial impact of Cxbladder Detect (Pacific Edge Diagnostics, Hummelstown, PA) on microhematuria evaluations.

A decision tree analysis was constructed by Coreva Scientific (Königswinter, Germany) comparing one-year costs of the standard microhematuria evaluation using the AUA Guidelines versus an algorithm incorporating Cxbladder Detect. Cxbladder Detect positive patients had cystoscopy and imaging, whereas patients with negative tests were re-evaluated in 6 months. Patients with positive diagnostic testing underwent cystoscopy, and positive cystoscopies led to TURBT. Test performance was based on published literature and costs were based on Medicare allowable fees.

Using the decision tree model, the average savings of using Cxbladder Detect was $559 compared with the standard of care, with an average reduction of 0.38 procedures per patient. Probabilistic analysis showed statistical significance with a median reduction in the total cost of $498 per patient (95% CrI [-1,356, -2]) and a significant median reduction in diagnostic procedures per patient of 0.36 (95% CrI [-0.52, -0.16]) without impact on the number of cancers diagnosed.

This model-based study demonstrates the potential economic value of using a Cxbladder-driven protocol for microhematuria evaluations.

Urology practice. 2023 Nov 01 [Epub ahead of print]

Mark D Tyson, Robert Abouassaly, Adri Durant, Antonia Bosworth Smith, Kim Seemann, Daniel A Shoskes

Mayo Clinic Arizona, Phoenix, Arizona., Cleveland Clinic, Cleveland, Ohio., Pacific Edge Diagnostics USA.