ABSTRACT
Objective:COVID-19 has challenged diagnostic and surveillance pathways for suspected and known bladder transitional cell cancer (TCC). Exclusion of high-grade/invasive TCC by molecular urine testing could risk stratify patients for priority flexible cystoscopy and transurethral resection (TUR). We evaluated ADXBladder (ArquerDx), which has a high negative predictive value (NPV) for high-grade and ? pT1 TCC.Patients and methods:Prospective cohort study of patients referred with haematuria for diagnostics or on TCC surveillance (Dec 2020?Feb 2021). Patients underwent ADXBladder testing, flexible cystoscopy and imaging (for haematuria), followed by TUR/biopsy as necessary. Clinico-radiological/pathology findings were compared with ADXBladder results.Results:Of 117 eligible patients, 39 and 78 had positive and negative ADXBladder tests, respectively. Of 15 suspected TCC on cystoscopy, eight were confirmed on TUR/biopsy. Overall ADXBladder NPV was 96.2% (CI: 91.0?98.4). NPV for high-grade and ?pT1 TCC was 97.4% (CI: 94.4?98.8) and 98.7% (CI: 95.0?99.7), respectively.Conclusions:Our ?real world? evaluation confirmed a high NPV for high grade and ?pT1 TCC using ADXBladder. Further larger studies are required to determine whether a negative ADXBladder test combined with negative imaging and patient risk factors may justify patient downgrading on timed diagnostic pathways.Level of evidence:IV