ArticleBJU international2021
Comparison of the performances of the ADXBLADDER test and urinary cytology in the follow-up of non-muscle-invasive bladder cancer: a blinded prospective multicentric study.
Article in BJU international, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05508568 (A Performance Evaluation Study of Arquer's MCM5 Elisa Test), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Xpert bladder cancer detection and monitor in urothelial carcinoma: systematic review and meta-analysis.Scientific reports · 2026Pooled it
- Urinary biomarkers for bladder cancer diagnosis and NMIBC follow-up: a systematic review.World journal of urology · 2023Pooled it
- Urinary biomarkers in multicentric studies: Shaping the future of bladder cancer diagnosis and follow-up.BJUI compass · 2025Review
- The diagnostic performance of a noninvasive urine-based methylation biomarkers Vimentin/POU4F2 to detect bladder carcinoma.BMC cancer · 2025Article
- Article
- Screening of immunotherapy-related genes in bladder cancer based on GEO datasets.Frontiers in oncology · 2023Article
- Review
- The Role of Fluorescence In Situ Hybridization in the Surveillance of Non-Muscle Invasive Bladder Cancer: An Updated Systematic Review and Meta-Analysis.Diagnostics (Basel, Switzerland) · 2022Review
- The Role of Novel Bladder Cancer Diagnostic and Surveillance Biomarkers-What Should a Urologist Really Know?International journal of environmental research and public health · 2022Review
- Proteomics for Early Detection of Non-Muscle-Invasive Bladder Cancer: Clinically Useful Urine Protein Biomarkers.Life (Basel, Switzerland) · 2022Review
- Prominence of urinary biomarkers for bladder cancer in the COVID-19 era: From the commercially available to new prospective candidates.Investigative and clinical urology · 2021Review
- Biomarkers in Bladder Cancer Surveillance.Frontiers in surgery · 2021Review
- ADXBLADDER test better than cytology for NMIBC follow-up monitoring.Nature reviews. Urology · 2020Article
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Authors and funding
16 authors at 9 institutions in 5 countries.
Funding
Abstract
objectiveTo compare directly the performance of the ADXBLADDER test with that of cytology in the detection of non-muscle-invasive bladder cancer (NMIBC) recurrences.
backgroundADXBLADDER is a urine test based on the detection of MCM5, a DNA licensing factor expressed in all cells capable of dividing. Expression is usually restricted to the basal stem cell compartment; however, in malignancy, MCM5-expressing cells can be found throughout the epithelium. Detection of MCM5 in urine sediment can be indicative of the presence of a bladder tumour. PATIENTS AND
methodsA multicentre prospective, blinded study was carried out from August 2017 and July 2019 at 21 European Union centres, 14 of which collected matching cytology data. Urine was collected from patients prior to cystoscopy. Urine cytology and ADXBLADDER were performed and compared to the diagnosis obtained by cystoscopy. The performance of cytology and ADXBLADDER were then compared.
resultsThe overall performance of ADXBLADDER demonstrated a sensitivity of 51.9%, a specificity of 66.4%, and a negative predictive value (NPV) of 92%. The sensitivity of ADXBLADDER for low- and high-grade recurrences was 44.1% and 58.8%, respectively. By contrast, cytology sensitivity was 16.7%, specificity was 98% and NPV was 90.7%. Cytology sensitivity for both low- and high-grade disease was 17.6%.
conclusionsADXBLADDER detection of both low- and high-grade NMIBC recurrence is superior to that of cytology, with ADXBLADDER able to exclude the presence of high-grade recurrence in 97.8% of cases compared to 97.1% with cytology. These results show that ADXBLADDER has promise as a more reliable alternative to urine cytology in the follow-up of NMIBC.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.