The Diagnostic Performance of Cxbladder Resolve, Alone and in Combination with Other Cxbladder Tests, in the Identification and Priority Evaluation of Patients at Risk for Urothelial Carcinoma.

Cxbladder (Cxb) tests combine genomic biomarkers in urine with phenotypic and clinical data to classify hematuria patients into those at low/high probability of urothelial carcinoma (UC). Cxbladder Resolve (CxbR) is designed for use after Cxb Triage (CxbT) and Detect (CxbD), where CxbT-positive tests reflex to CxbD and CxbD-positive to CxbR, to identify patients at high probability of high-impact tumors (HIT: high grade Ta, Tis or T1-T3). This study validated the diagnostic performance of CxbR in identifying HIT, and validated the algorithm of Cxb tests to segregate high-impact from low-impact tumors.

CxbR was developed in 863 hematuria patients in three studies in USA, Australia and New Zealand. CxbR, separately and combined with other Cxb tests, was validated in a prospective, observational US study in 548 hematuria patients. All UC diagnoses were confirmed by histopathology.

In the development dataset, CxbR sensitivity was 92.4% (95% CI 83.3-96.7) and specificity 93.8% (95% CI 86.8-97.2) for identifying HIT within the high priority category. During external validation, sequential Cxb tests correctly ruled out 87.6% of patients from further work-up (negative predictive value 99.4%); 100% of HIT were correctly identified (specificity 96.3%), and three low-grade tumors were missed. In both studies, all patients with HIT were correctly assigned to prioritized evaluation.

CxbR has high sensitivity and specificity, correctly identifying all HIT. Sequential Cxb tests accurately segregate patients with a low vs high probability of HIT, focusing resources on those patients, with a diagnostic yield 4.8-fold higher than AUA guideline stratification.

The Journal of urology. 2021 Aug 05 [Epub ahead of print]

Jay D Raman, Laimonis Kavalieris, Badrinath Konety, Sima Porten, Siamak Daneshmand, Yair Lotan, Ronald Loo

Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania., Pacific Edge Ltd, Dunedin, New Zealand., Rush Medical College, Chicago, Illinois., Department of Urology, University of California San Francisco, San Francisco, California., USC Department of Urology, USC/Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, California., Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas., Kaiser Permanente, Pasadena, California.

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