The Bladder EpiCheck Test as a Non-Invasive Tool Based on the Identification of DNA Methylation in Bladder Cancer Cells in the Urine: A Review of Published Evidence

Mancini, Mariangela; Righetto, Marialaura; Zumerle, Sara; Montopoli, Monica; Zattoni, Filiberto

doi:10.3390/ijms21186542

Cited by 42 publications

(35 citation statements)

References 20 publications

(55 reference statements)

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“…The dual-marker assay (sensitivities of 88.1–91.2% and specificities of 85.7–89.7%) also exhibited comparable performance to the methylation assay currently in the Europe’s study, the Bladder EpiCheck, with reported sensitivities of 62.5–90% and specificities of 82.1–90.0% [ 28 ]. While the Bladder EpiCheck utilizes a panel of 15 methylation markers, the assay of dual-marker and five-marker three-class risk stratification models can further reduce the cost in a clinical screening setting.…”

Section: Discussionmentioning

confidence: 99%

A urine-based DNA methylation assay to facilitate early detection and risk stratification of bladder cancer

Ruan¹,

Chen

Huang

et al. 2021

Clin Epigenet

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Background Current non-invasive tests have limited sensitivities and lack capabilities of pre-operative risk stratification for bladder cancer (BC) diagnosis. We aimed to develop and validate a urine-based DNA methylation assay as a clinically feasible test for improving BC detection and enabling pre-operative risk stratifications. Methods A urine-based DNA methylation assay was developed and validated by retrospective single-center studies in patients of suspected BC in Cohort 1 (n = 192) and Cohort 2 (n = 98), respectively. In addition, a prospective single-center study in hematuria patient group (Cohort 3, n = 174) was used as a second validation of the model. Results The assay with a dual-marker detection model showed 88.1% and 91.2% sensitivities, 89.7% and 85.7% specificities in validation Cohort 2 (patients of suspected BC) and Cohort 3 (patients of hematuria), respectively. Furthermore, this assay showed improved sensitivities over cytology and FISH on detecting low-grade tumor (66.7–77.8% vs. 0.0–22.2%, 0.0–22.2%), Ta tumor (83.3% vs. 22.2–41.2%, 44.4–52.9%) and non-muscle invasive BC (NMIBC) (80.0–89.7% vs. 51.5–52.0%, 59.4–72.0%) in both cohorts. The assay also had higher accuracies (88.9–95.8%) in diagnosing cases with concurrent genitourinary disorders as compared to cytology (55.6–70.8%) and FISH (72.2–77.8%). Meanwhile, the assay with a five-marker stratification model identified high-risk NMIBC and muscle invasive BC with 90.5% sensitivity and 86.8% specificity in Cohort 2. Conclusions The urine-based DNA methylation assay represents a highly sensitive and specific approach for BC early-stage detection and risk stratification. It has a potential to be used as a routine test to improve diagnosis and prognosis of BC in clinic.

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Section: Discussionmentioning

confidence: 99%

A urine-based DNA methylation assay to facilitate early detection and risk stratification of bladder cancer

Ruan¹,

Chen

Huang

et al. 2021

Clin Epigenet

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“…The Bladder EpiCheck (Nucleix; Rehovot, Israel) test is based on an analysis of the panel of 15 DNA (deoxyribonucleic acid) biomarkers, associated with urinary bladder carcinoma. The test requires small amounts of DNA, isolated from easily available urine samples, while being simultaneously characterised by very high, clinically proven sensitivity, specificity and negative predictive value [ 5 ]. The Bladder EpiCheck test has been designed for the non-invasive monitoring of malignant relapses.…”

Section: Methodsmentioning

confidence: 99%

The Usefulness of Cell-Based and Liquid-Based Urine Tests in Clarifying the Diagnosis and Monitoring the Course of Urothelial Carcinoma. Identification of Novel, Potentially Actionable, RB1 and ERBB2 Somatic Mutations

Kałużewski

Przybylski

Bednarek³

et al. 2021

JPM

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Bladder cancer is one of the most common cancers in global statistics. One of the issues associated with this disease is the high incidence of cases with delayed diagnosis and what factors correlate with worse treatment outcomes. A possible reason for this may be the rather limited availability of non-invasive diagnostic tools. This short communication presents a case of a 68 year old male patient after an ineffective therapy, carried on for several years with symptoms commonly associated with prostate overgrowth that masked a carcinoma in situ of the urinary bladder. Implementation of several diagnostic techniques, including urine sediment cytology, immunocytochemistry, the fluorescence in situ hybridisation technique, the Bladder EpiCheck test and whole-genome sequencing, enabled the establishment of a correct diagnosis, implementation of appropriate treatment and provision of patient-friendly monitoring. The described case emphasises the usefulness of cell-based and liquid-based urine tests in bladder cancer diagnostic procedures.

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“…DNA methylation pattern changed during progression from NMIBC to MIBC [ 27 ]. Changes in DNA methylation pattern of a panel of 15 genomic biomarkers detected by RT-PCR was used in the Bladder EpiCheck (Nucleix, Rehovot, Israel) [ 28 ]. The test provides a score, which is considered positive for values higher than 60 [ 29 ].…”

Section: Dna Methylationmentioning

confidence: 99%

Liquid Biopsy Biomarkers in Urine: A Route towards Molecular Diagnosis and Personalized Medicine of Bladder Cancer

Ferro

Civita

Liotti

et al. 2021

JPM

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Bladder cancer (BC) is characterized by high incidence and recurrence rates together with genomic instability and elevated mutation degree. Currently, cystoscopy combined with cytology is routinely used for diagnosis, prognosis and disease surveillance. Such an approach is often associated with several side effects, discomfort for the patient and high economic burden. Thus, there is an essential demand of non-invasive, sensitive, fast and inexpensive biomarkers for clinical management of BC patients. In this context, liquid biopsy represents a very promising tool that has been widely investigated over the last decade. Liquid biopsy will likely be at the basis of patient selection for precision medicine, both in terms of treatment choice and real-time monitoring of therapeutic effects. Several different urinary biomarkers have been proposed for liquid biopsy in BC, including DNA methylation and mutations, protein-based assays, non-coding RNAs and mRNA signatures. In this review, we summarized the state of the art on different available tests concerning their potential clinical applications for BC detection, prognosis, surveillance and response to therapy.

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The Bladder EpiCheck Test as a Non-Invasive Tool Based on the Identification of DNA Methylation in Bladder Cancer Cells in the Urine: A Review of Published Evidence

Cited by 42 publications

References 20 publications

A urine-based DNA methylation assay to facilitate early detection and risk stratification of bladder cancer

A urine-based DNA methylation assay to facilitate early detection and risk stratification of bladder cancer

The Usefulness of Cell-Based and Liquid-Based Urine Tests in Clarifying the Diagnosis and Monitoring the Course of Urothelial Carcinoma. Identification of Novel, Potentially Actionable, RB1 and ERBB2 Somatic Mutations

Liquid Biopsy Biomarkers in Urine: A Route towards Molecular Diagnosis and Personalized Medicine of Bladder Cancer

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