A Novel, non-invasive Test Enabling Bladder Cancer Detection in Urine Sediment of Patients Presenting with Haematuria—A Prospective Multicentre Performance Evaluation of ADXBLADDER

Dudderidge, Tim; Stockley, Jacqueline; Nabi, Ghulam; Mom, Jaswant; Umez-Eronini, Nkemi; Hrouda, David; Cresswell, Jo; McCracken, Stuart

doi:10.1016/j.euo.2019.06.006

Cited by 41 publications

(31 citation statements)

References 7 publications

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“…The hypothesis is that well differentiated cells in the bladder, in contact with urine, do not contain MCM5 whereas bladder cancer cells able to undergo cell division contain MCM5. MCM5 as biomarker for the first diagnosis of BCa has been analyzed in a limited number of previous studies with different populations and different results in terms of sensitivity and specificity 12,14‐17 …”

Section: Discussionmentioning

confidence: 99%

“…However, in their population BCa diagnosis showed a high percentage of pT1 stage or above (muscle‐invasive). Of the 20/74 tumors undetected by ADXBLADDER, 19/20 were pTa tumors and 14/20 were low grade 12 …”

Section: Discussionmentioning

confidence: 99%

“…After being mixed gently and incubated for at least 30 minutes at room temperature to allow complete cell lysis, the lysates were aliquoted and stored at −20 C until analysis.Samples were tested in duplicate using and according to manufacturer's instructions 12. The cut off value of MCM5 was 0.013 Au, with intra-assay CV of 8.3% and inter-assay CV of 20%.…”

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confidence: 99%

“…However, in their population BCa diagnosis showed a high percentage of pT1 stage or above (muscle-invasive). Of the 20/74 tumors undetected by ADXBLADDER, 19/20 were pTa tumors and 14/20 were low grade 12. An ideal diagnostic test for the initial diagnosis of BCa should give high sensitivity and specificity in particular for low stage tumors and independently to histological grading.…”

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confidence: 99%

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Predictive value of MCM5 (ADXBLADDER) analysis in urine of men evaluated for the initial diagnosis of bladder cancer: A comparative prospective study

Anastasi

Maggi

Tartaglione

et al. 2020

Diagnostic Cytopathology

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Background: To compare predictive value of MCM5 to urinary cytology (UC) for the primary diagnosis of bladder cancer (BCa). Methods: We prospectively enrolled 91 patients who presented macroscopic hematuria or persistent lower urinary tract symptoms at our institution. Single voided midstream urine specimens were collected for UC and MCM5 (ADXBLADDER; Arquer Diagnostics Ltd, Sunderland, United Kingdom) assessment. Cystoscopy was used as confirmatory test, and positive cases underwent transurethral resection of bladder tumor with histopathological evaluation. Results: Forty cases (43.9%) showed a positive cystoscopy for BCa. Histology was obtained in 37 cases: 16 (43.2%) high-grade (HG) and 21 (56.8%) low-grade (LG) transitional cell carcinoma (TCC). UC had a sensitivity of 62.5%, specificity of 86.3%, PPV of 78.1% and NPV of 74.6%. Sensitivity, specificity, PPV and NPV of MCM5 were 60.0%, 88.2%, 80.0% and 73.8%, respectively. According to tumor grade, MCM5 and UC showed a sensitivity of 47.6% and 52.4% in LG, and 87.5% and 75.0%, respectively, in HG TCC. False-positive rates were 11.8% and 13.7% of negative cases for BCa with MCM5 and UC test, whereas false-negative results were found in 40.0% and 37.5% of BCa cases, respectively. The combination of the two tests showed a sensitivity of 71.4% in LG, and 93.8% in HG TCC. Conclusion: In the present analysis, MCM5 showed lower sensitivity than UC in predicting BCa primary diagnosis. According to tumor grade, MCM5 showed a higher sensitivity in the detection of HG BCa compared to UC, although values were not significantly different.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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confidence: 99%

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Predictive value of MCM5 (ADXBLADDER) analysis in urine of men evaluated for the initial diagnosis of bladder cancer: A comparative prospective study

Anastasi

Maggi

Tartaglione

et al. 2020

Diagnostic Cytopathology

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“…The method of detecting MCM5 in urine sediment has been shown to accurately diagnose BCa in a number of previous studies, with particularly high sensitivity for high‐risk disease (high‐grade, pT1 and above and carcinoma in situ [CIS] tumours) [8–11].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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Objective To compare directly the performance of the ADXBLADDER test with that of cytology in the detection of non‐muscle‐invasive bladder cancer (NMIBC) recurrences. Background ADXBLADDER 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 Methods A 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. Results The 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%. Conclusions ADXBLADDER 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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Urine‐based liquid biopsy in bladder cancer: Opportunities and challenges

Wang

Jin

et al. 2023

Clinical and Translational Dis

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Bladder cancer (BLCA) is a most common urological tumours with high rate of recurrence, which needs long‐term of follow‐up. To date, diagnosis and surveillance of BLCA still rely on cystoscopy, an invasive and expensive method that increases the difficulty for routine follow‐up. Therefore, exploring new biomarkers or tests is an effective way to improve the current clinical management of BLCA. Recent years, liquid biopsy has received increasing attention, especially for its great potential for clinical application in the non‐invasive detection of tumours. In addition, liquid biopsy involves a wide range of biomarkers, including DNA, RNA, proteins, extracellular vesicles and metabolites in blood, urine or other body fluids. For BLCA, urine is a most ideal body fluid to achieve non‐invasive diagnosis and surveillance. Here, we address recent developments of urine‐based biomarkers or tests for clinical diagnostic challenges in BLCA, such as early detection, minimal residual, recurrence monitoring and therapeutic response. Meanwhile, the many challenges of urine biomarkers that need to be overcome are also discussed.

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A Novel, non-invasive Test Enabling Bladder Cancer Detection in Urine Sediment of Patients Presenting with Haematuria—A Prospective Multicentre Performance Evaluation of ADXBLADDER

Cited by 41 publications

References 7 publications

Predictive value of MCM5 (ADXBLADDER) analysis in urine of men evaluated for the initial diagnosis of bladder cancer: A comparative prospective study

Predictive value of MCM5 (ADXBLADDER) analysis in urine of men evaluated for the initial diagnosis of bladder cancer: A comparative prospective study

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

Urine‐based liquid biopsy in bladder cancer: Opportunities and challenges

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