ADXBladder molecular urine testing to risk stratify and prioritise management of suspected and known bladder cancers during the COVID-19 pandemic

Abstract

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. 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. 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. 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. IV