Badrinath Konety1, Neal Shore2, Andrew Karim Kader3, Sima Porten4, Siamak Daneshmand5, Tony Lough6, Yair Lotan7. 1. Department of Urology, University of Minnesota, Minneapolis, MN, USA. Electronic address: brkonety@umn.edu. 2. Carolina Urologic Research Center, Myrtle Beach, SC, USA. 3. Department of Urology, UC San Diego, La Jolla, CA, USA. 4. Department of Urology, UC San Francisco, San Francisco, CA, USA. 5. USC Institute of Urology, USC/Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA. 6. Pacific Edge Ltd, Dunedin, New Zealand. 7. University of Texas Southwestern Medical Center, Department of Urology, Dallas, TX, USA.
Abstract
BACKGROUND: Cxbladder diagnostic tests combine genomic information from urinary mRNA with phenotypic information to either rule out low-risk individuals or identify patients at a high risk of urothelial carcinoma (UC). OBJECTIVE: To evaluate the performance of Cxbladder and urine cytology, and Cxbladder's adjudication of atypical cytology and equivocal cystoscopy. DESIGN, SETTING, AND PARTICIPANTS: This is a retrospective analysis of pooled data from three prospective Cxbladder clinical trials and one real-world clinical study. Physicians were blinded to Cxbladder results, and Cxbladder providers were blinded to clinical results. This study analyzed diverse urology practices in the USA, Australia, and New Zealand. A total of 1784 consecutive, prospectively recruited patients with hematuria or previously diagnosed UC provided 852 samples with both local cytology and Cxbladder results; 153 had atypical cytologies and 14 had both atypical cytology and equivocal cystoscopy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Negative predictive value (NPV) and proportion of tumors missed for Cxbladder and local cytology, and evaluation of Cxbladder for adjudicating atypical cytology and equivocal cystoscopy. RESULTS AND LIMITATIONS: Cxbladder ruled out 35% of patients and NPV 97% (95% confidence interval [CI] 94-98%) compared with 93% (95% CI 91-94%) for cytology; Cxbladder missed 8.5% and cytology missed 63% of tumors. UC was diagnosed in 26/153 cases of atypical cytology (17%). Cxbladder correctly adjudicated all these patients including those with both atypical cytology and equivocal cystoscopy; these patients had a positive Cxbladder result and were diagnosed with UC by pathology. The incidence of patients with both atypical cytology and equivocal cystoscopy is low. CONCLUSIONS: Cxbladder correctly adjudicated all patients diagnosed with UC among those with atypical cytology and equivocal cystoscopy, and outperformed cytology for accurately identifying patients who do not have UC. PATIENT SUMMARY: Cxbladder accurately rules out patients who do not have cancer, and adjudicates cytology and cystoscopy with inconclusive results, minimizing the need for patients to undergo further unnecessary tests and procedures.
BACKGROUND: Cxbladder diagnostic tests combine genomic information from urinary mRNA with phenotypic information to either rule out low-risk individuals or identify patients at a high risk of urothelial carcinoma (UC). OBJECTIVE: To evaluate the performance of Cxbladder and urine cytology, and Cxbladder's adjudication of atypical cytology and equivocal cystoscopy. DESIGN, SETTING, AND PARTICIPANTS: This is a retrospective analysis of pooled data from three prospective Cxbladder clinical trials and one real-world clinical study. Physicians were blinded to Cxbladder results, and Cxbladder providers were blinded to clinical results. This study analyzed diverse urology practices in the USA, Australia, and New Zealand. A total of 1784 consecutive, prospectively recruited patients with hematuria or previously diagnosed UC provided 852 samples with both local cytology and Cxbladder results; 153 had atypical cytologies and 14 had both atypical cytology and equivocal cystoscopy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Negative predictive value (NPV) and proportion of tumors missed for Cxbladder and local cytology, and evaluation of Cxbladder for adjudicating atypical cytology and equivocal cystoscopy. RESULTS AND LIMITATIONS: Cxbladder ruled out 35% of patients and NPV 97% (95% confidence interval [CI] 94-98%) compared with 93% (95% CI 91-94%) for cytology; Cxbladder missed 8.5% and cytology missed 63% of tumors. UC was diagnosed in 26/153 cases of atypical cytology (17%). Cxbladder correctly adjudicated all these patients including those with both atypical cytology and equivocal cystoscopy; these patients had a positive Cxbladder result and were diagnosed with UC by pathology. The incidence of patients with both atypical cytology and equivocal cystoscopy is low. CONCLUSIONS: Cxbladder correctly adjudicated all patients diagnosed with UC among those with atypical cytology and equivocal cystoscopy, and outperformed cytology for accurately identifying patients who do not have UC. PATIENT SUMMARY: Cxbladder accurately rules out patients who do not have cancer, and adjudicates cytology and cystoscopy with inconclusive results, minimizing the need for patients to undergo further unnecessary tests and procedures.
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