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

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