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TEST:
Bladder EpiCheck®

Company:
Nucleix
Type:
CE Marked
Related tests:
Evidence

News

9d
Prospective evaluation of the RT-PCR based urinary marker Bladder Epicheck® as a diagnostic tool in upper urinary tract tumor. (PubMed, Minerva Urol Nephrol)
Due to its high sensitivity for HG tumors, the Bladder Epicheck® Test can be used in diagnosis and treatment decision-making of UTUC. Furthermore, it could be very useful in follow-up of UTUC, after endoscopic treatment to postpone or avoid unnecessary endoscopic exploration. Even if further studies are needed to validate these findings, Bladder Epicheck® could be a promising clinical tool for detection of UTUC.
Journal
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Bladder EpiCheck®
1m
Simulation of the effects of molecular urine markers in follow-up of patients with high-risk non-muscle invasive bladder cancer. (PubMed, Urol Oncol)
"Based on the results of this simulation, a marker-supported follow-up of patients with HR NMIBC is safe and offers the option to significantly reduce the number of WLCs. Further research focusing on prospective randomized trials is needed to finally find a way to implement urine markers into clinical decision-making."
Journal • Review
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MCM5 (Minichromosome Maintenance Complex Component 5)
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ADXBLADDER • Bladder EpiCheck® • Xpert® Bladder Cancer Monitor
3ms
Methylation Analysis of Urinary Sample in Non-Muscle-Invasive Bladder Carcinoma: Frequency and Management of Invalid Result. (PubMed)
In the follow-up for NMIBC, for patients for whom a BE test is planned, a combined approach of cytology and a methylation test is recommended in order to repeat the BE test with an invalid result only in those cases with a cytological diagnosis of atypical urothelial cells (AUC) suspicious for high-grade urothelial carcinoma (SHGUC) and high-grade urothelial carcinoma (HGUC).
Journal
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Bladder EpiCheck®
4ms
Enrollment open • Trial initiation date
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Bladder EpiCheck® • Xpert® Bladder Cancer Monitor
5ms
Consistent performance of Bladder EpiCheck for NMIBC surveillance in the USA and European pivotal studies and in real world studies (SUO 2023)
Bladder EpiCheck demonstrated excellent and consistent performance for NMIBC surveillance across pivotal and independent studies performed in various populations and labs. The high HG NPV supports the use of Bladder EpiCheck as a rule-out test for HG disease. With a high specificity and PPV, Bladder Epicheck's false positive rates are low, potentially minimizing unnecessary downstream procedures and patient anxiety.
Real-world evidence • Clinical • Real-world
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Bladder EpiCheck®
5ms
Nucleix Receives Reimbursement for Bladder EpiCheck in the Netherlands (Businesswire)
"Nucleix...announced it has been informed it will receive national reimbursement approval from The Dutch Healthcare Authority (NZA) in the Netherlands, effective January 1, 2024, for its CE-marked Bladder EpiCheck® test for detection of primary or recurrent bladder cancer and upper tract urinary cancer."
Reimbursement
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Bladder EpiCheck®
5ms
Nucleix Bladder EpiCheck® now available in France via the Association Francaise d'Urologie (AFU) Registry for surveillance of recurrence of bladder cancer (Businesswire)
"Nucleix...announced participation in the Association Francaise d'Urologie (AFU) Registry of the Therapeutic Management and Follow-Up of Non-Muscle-Invasive Bladder Cancer (TVNIM-AFU). The registry will evaluate the diagnostic performance of selected urine biomarkers in French patients and compare them to the results of bladder endoscopies (cystoscopy) performed over two years for routine follow-up of NMIBC. The registry is open to all urologists who are members of the AFU to include patients undergoing tumor resection."
Clinical
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Bladder EpiCheck®
7ms
Bladder Epicheck Test: A Novel Tool to Support Urothelial Carcinoma Diagnosis in Urine Samples. (PubMed, Int J Mol Sci)
This review assesses the importance of methylation analysis and the Bladder EpiCheck test as urinary biomarkers for diagnosing urothelial carcinomas in patients in follow-up for NMIBC, helping cytology and cystoscopy in doubtful cases. A combined approach of cytology and methylation analysis is suggested not only to diagnose HGUC, but also to predict clinical and histological recurrences.
Journal • Review
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Bladder EpiCheck®
11ms
Nucleix’s Bladder EpiCheck Receives FDA 510(k) Clearance for Monitoring of Non-Muscle Invasive Bladder Cancer (NMIBC) Recurrence (Businesswire)
"Nucleix...has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Bladder EpiCheck® for use as a non-invasive method for surveillance of tumor recurrence in patients previously diagnosed with non-muscle invasive bladder cancer (NMIBC), in conjunction with cystoscopy....Bladder EpiCheck is a highly sensitive and specific test that analyzes subtle disease-specific changes across 15 methylation markers that are associated with bladder cancer. The test is commercially available in Europe and is the first of its kind methylation-based urine test performed on a qPCR platform to be cleared by the FDA....Nucleix is evaluating strategic partnerships and other market access activities for the commercial launch of Bladder EpiCheck in the United States."
FDA event
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Bladder EpiCheck®
11ms
Clinical performance of Bladder EpiCheck methylation test for active surveillance of non-muscle invasive bladder cancer: Systematic review and meta-analysis. (ASCO 2023)
The Bladder EpiCheck test has a better sensitivity than urine cytology and may be utilized as a part of the active surveillance strategy for NIMBC recurrence.
Retrospective data • Review
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Bladder EpiCheck®
12ms
ReplaceCysto: Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance (clinicaltrials.gov)
P=N/A | N=240 | Not yet recruiting | Sponsor: White River Junction Veterans Affairs Medical Center
New trial
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Bladder EpiCheck® • Xpert® Bladder Cancer Monitor
1year
Diagnostic value of Xpert® BC Detection, Bladder Epicheck®, Urovysion® FISH and cytology in the detection of upper urinary tract urothelial carcinoma. (PubMed, World J Urol)
"Bladder-Epicheck® and Urovysion®FISH along with cytology could be a helpful ancillary method in the diagnosis and follow-up of UTUC while due to its low specificity Xpert®-BC Detection seems to be of limited usefulness."
Journal
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Bladder EpiCheck® • UroVysion™ Bladder Cancer Kit (UroVysion Kit) • Xpert® Bladder Cancer Monitor
1year
DNA methylation analysis in urinary samples: A useful method to predict the risk of neoplastic recurrence in patients with urothelial carcinoma of the bladder in the high-risk group. (PubMed, Cancer Cytopathol)
To the best of the authors' knowledge, this is the first study in which patients at high risk for HGUC were stratified using the Bladder EpiCheck EpiScore. The results validate this methylation analysis tool as a useful method for predicting recurrent HGUC during the follow-up of patients with nonmuscle-invasive bladder carcinoma.
Journal • Epigenetic controller
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Bladder EpiCheck®
over1year
Bladder EpiCheck urine test in the follow-up of NMIBC: a cost analysis. (PubMed, World J Urol)
To conclude, the BE can be used to reduce the costs of NMIBC follow-up, with a small delay in diagnosis of recurrent disease.
HEOR • Journal
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Bladder EpiCheck®
over1year
The Role of Bladder Epicheck Test In Follow-Up of Patients with Non-Muscle Invasive Bladder Cancer. (PubMed, Clin Genitourin Cancer)
The EpiCheck (test showed very high diagnostic values, higher than the currently, gold standard. The test might clinically improve the BCa management in terms of, reduced number of inconclusive/suspicious reports of cytology and endoscopy, reduced number of further examinations, reduced associated patient and economic.
Journal
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Bladder EpiCheck®
over1year
Usefulness of the Urine Methylation Test (Bladder EpiCheck) in Follow-Up Patients with Non-Muscle Invasive Bladder Cancer and Cytological Diagnosis of Atypical Urothelial Cells-An Institutional Study. (PubMed, J Clin Med)
We demonstrated the usefulness of a DNA methylation test in the follow-up of patients diagnosed with urothelial carcinoma. The methylation test also helps to diagnose urothelial cell atypia.
Journal
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Bladder EpiCheck®
almost2years
Nucleix Expands EU Label Indication of Bladder EpiCheck to Include the Detection of Primary Bladder Cancer and Detection of Primary and Recurrent Upper Tract Urinary Cancer (Businesswire)
"Nucleix...announced that the company has expanded the European Union (EU) label indication of its Bladder EpiCheck® test. Bladder EpiCheck detects DNA methylation patterns in urine that are associated with urothelial cancer....The current update expands the label indication to also include aiding in the detection of primary bladder cancer and upper tract urothelial carcinoma (UTUC) in patients presenting with hematuria and/or other urinary tract symptoms and/or findings with a suspicion of malignancy, and the detection of recurrent UTUC, in conjunction with standard diagnostic procedures."
European regulatory
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Bladder EpiCheck®
almost2years
Clinical
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Bladder EpiCheck®
almost2years
DNA Methylation Urine Biomarkers Test in the Diagnosis of Upper Tract Urothelial Carcinoma: Results from a Single-Center Prospective Clinical Trial. (PubMed, J Urol)
Epicheck may be an important tool to decrease number of unnecessary URS. The clinical implementation of EpiCheck in UTUC warrants further investigation in multicentric prospective randomized trials.
Journal • Biomarker testing • Epigenetic controller
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Bladder EpiCheck®
almost2years
The role of a DNA methylation test in the surveillance of bladder cancer: a single-center blinded prospective study (AUA 2022)
The AUC was 81%(95%CI:73-89) for AG BC, and 96%(95%CI:88-100) for HG BC. Conclusions : BE showed high diagnostic performance in HG BC.
Clinical • Epigenetic controller
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Bladder EpiCheck®
2years
Bladder EpiCheck Included in 2022 European Association of Urology (EAU) Clinical Guidelines on Non-Muscle Invasive Bladder Cancer (NMIBC) (Businesswire)
"Nucleix...announced its Bladder EpiCheck® test has been included in the 2022 European Association of Urology (EAU) Clinical Guidelines for non-muscle invasive bladder cancer (NMIBC)...The EAU guidelines state that urinary biomarker tests with high sensitivity and negative predictive values for high-grade disease, including a specific reference to Bladder EpiCheck, might be used to replace and/or postpone cystoscopies in low- and intermediate-risk NMIBC, and reduce the number of cystoscopies in this patient population."
Clinical guideline
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Bladder EpiCheck®
over2years
Diagnostic performance of the Bladder EpiCheck methylation test and photodynamic diagnosis-guided cystoscopy in the surveillance of high-risk non-muscle invasive bladder cancer: A single centre, prospective, blinded clinical trial. (PubMed, Urol Oncol)
BE is a very accurate diagnostic tool that has the potential to be useful in the surveillance of high-risk BC patients. Especially when combined with UC, it may be used to reduce the number of cystoscopies needed throughout follow-up. Conversely, the use of PDD as a diagnostic tool in such patients should be reconsidered. However, due to the small sample size of this study, a larger prospective clinical trial should be performed to confirm findings.
Journal • Clinical
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Bladder EpiCheck®
over2years
Journal • Clinical
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Bladder EpiCheck®
|
mitomycin
over2years
Accuracy of novel urinary biomarker tests for diagnosis and surveillance of NMIBC: A systematic review, diagnostic test accuracy and network meta-analyses (EMUC 2021)
There is not enough data to reliably assess their use in the primary diagnostic setting. These results have to be confirmed in larger cohort as well as in head-to-head comparative studies.
Review
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ADXBLADDER • Bladder EpiCheck® • Cxbladder • Uromonitor® • Xpert® Bladder Cancer Monitor
over2years
Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non-muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis. (PubMed, Eur Urol Oncol)
"Our analyses support high diagnostic accuracy of the studied novel UBTs, supporting their utility in the NMIBC surveillance setting. All of these might potentially help prevent unnecessary cystoscopies safely. There are not enough data to reliably assess their use in the primary diagnostic setting. These results have to be confirmed in a larger cohort as well as in head-to-head comparative studies. Nevertheless, our study might help policymakers and stakeholders evaluate the clinical and social impact of the implementation of these tests into daily practice."
Journal • Retrospective data • Review
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ADXBLADDER • Bladder EpiCheck® • Cxbladder • Uromonitor®
over2years
Upper urothelial tract High Grade Carcinoma: Comparison of Urine Cytology and DNA Methylation Analysis in Urinary Samples. (PubMed, Hum Pathol)
The methylation analysis of urinary samples may represent a valid tool in the diagnostic process of patients with suspected UTUC. In cases with difficult clinical decision after upper urinary tract biopsy and cytology, the methylation test could assist in the clinical management of UTUC patients.
Journal • Epigenetic controller
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Bladder EpiCheck®
over2years
The role of Bladder Epicheck in patients with Atypical urothelial cells in the voided urinary cytology (AUA 2021)
The AUC is a category of urinary cytology that could be inconclusive and need to be strictly followed in order to avoid the risk of missing tumor recurrence during follow-up of HG NMBC. Epicheck is a non invasive tool that overcome cytology in some situations and could be helpful in case where cytology is not straightforward. The inclusion of this non invasive tool in the routinary diagnostic setting of patients with HG NMBC must be considered and larger studies for the use of Epicheck in inconclusive cytology must be evaluated.
Clinical
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Bladder EpiCheck®
over2years
DNA methylation urine biomarkers test (EpiCheck® assay) in the diagnosis of upper tract urothelial carcinoma: results from a single-center prospective study (AUA 2021)
EpiCheck® appears to be a useful tool in the UTUC setting and it could find a crucial role in the diagnosis and follow-up of UTUC, particularly in detecting the absence of a high-grade disease. As EpiCheck® results are remarkable, this assay is now included in the diagnostic work-up of UTUC at our center
Clinical • Epigenetic controller
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Bladder EpiCheck®
almost3years
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. (PubMed, J Pers Med)
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.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • RB1 (RB Transcriptional Corepressor 1)
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HER-2 mutation
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Bladder EpiCheck®
almost3years
The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma (clinicaltrials.gov)
P=N/A; Active, not recruiting --> Completed | Trial completion date: Dec 2020 --> Jul 2020
Trial completion date • Trial completion • Clinical
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Bladder EpiCheck®
almost3years
Trial completion • Clinical
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Bladder EpiCheck®
3years
New trial
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Bladder EpiCheck®
3years
Novel urinary biomarkers ADXBLADDER and bladder EpiCheck for diagnostics of bladder cancer: A review. (PubMed, Urol Oncol)
The main biomarker objective should be to rule out high grade tumor recurrence without the need for any invasive procedures. Nevertheless, the clinical implementation of these biomarkers in the follow up of NMIBC has to be further investigated in prospective randomized trials for low as well as high grade tumors.
Journal • Review
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ADXBLADDER • Bladder EpiCheck® • UroVysion™ Bladder Cancer Kit (UroVysion Kit)
over3years
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. (PubMed, Int J Mol Sci)
This test, due to its non-invasive nature and highly promising performance could, in future, become an invaluable tool in the follow-up of bladder cancer patients. Potential new applications could include diagnosis and surveillance of upper-tract disease, for the replacement of invasive testing and ureteroscopy.
Journal • Review
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Bladder EpiCheck®
over3years
The combination cytology/epichek test in non muscle invasive bladder carcinoma follow-up: Effective tool or useless expence? (PubMed, Urol Oncol)
"Cytology and Bladder EpiCheck test in combination may have the potential to reduce cystoscopies in the follow-up of non-muscle invasive bladder cancer only for cytological diagnoses of atypical urothelial cells and Suspicious for High Grade Urothelial Carcinoma . Moreover, in patients with a cytological diagnosis of Negative for high grade urothelial carcinoma or HGUC, cytology alone seems to be safe and cost-effective."
Journal
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Bladder EpiCheck®
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mitomycin