CE Mark Granted to Urine Test for Bladder Cancer
By LabMedica International staff writers Posted on 12 Apr 2017 |
Image: The Bladder EpiCheck urine test is designed to help urologists to better monitor their bladder cancer patients (Photo courtesy of Medical Daily).
The new test performed with superior results over all other non-invasive tests examined in a European multi-center study for bladder cancer monitoring.
The European Union’s CE Mark was granted to Nucleix’s (Rehovot, Israel) Bladder EpiCheck test, aimed to help urologists to better monitor their bladder cancer patients. Bladder EpiCheck is a urine test that includes a panel of 15 proprietary biomarkers that are multiplexed in a real-time PCR analysis.
This regulatory approval follows the completion of a multi-center, prospective, and blinded clinical study that was performed in leading urology centers in Europe, with over 400 patients recruited in their first year of follow up. The study compared Bladder EpiCheck to the current gold standard follow up sequence (cystoscopy, cytology, and pathology for the positives). The Bladder EpiCheck results showed 99% Negative Predictive Value (NPV, excluding Ta-LG patients), 92% sensitivity (excluding Ta-LG patients), and 88% Specificity. Nucleix presented the results during the European Association of Urology (EAU) annual meeting (March 24-28, London, UK).
"These are important milestones for bladder cancer patients and urologists, adding an additional tool to their arsenal fighting bladder cancer," said Elon Ganor, Nucleix's co-founder and CEO, "These results show best-in-class performance for Bladder EpiCheck and will strongly support our launch in Europe."
Nucleix develops non-invasive molecular cancer diagnostic tests based on identification of subtle epigenetic changes in methylation patterns. Nucleix technology is based on a combination of a new biochemical assay in conjunction with sophisticated algorithms. The Nucleix pipeline includes a screening diagnostic blood test for early lung cancer detection.
The European Union’s CE Mark was granted to Nucleix’s (Rehovot, Israel) Bladder EpiCheck test, aimed to help urologists to better monitor their bladder cancer patients. Bladder EpiCheck is a urine test that includes a panel of 15 proprietary biomarkers that are multiplexed in a real-time PCR analysis.
This regulatory approval follows the completion of a multi-center, prospective, and blinded clinical study that was performed in leading urology centers in Europe, with over 400 patients recruited in their first year of follow up. The study compared Bladder EpiCheck to the current gold standard follow up sequence (cystoscopy, cytology, and pathology for the positives). The Bladder EpiCheck results showed 99% Negative Predictive Value (NPV, excluding Ta-LG patients), 92% sensitivity (excluding Ta-LG patients), and 88% Specificity. Nucleix presented the results during the European Association of Urology (EAU) annual meeting (March 24-28, London, UK).
"These are important milestones for bladder cancer patients and urologists, adding an additional tool to their arsenal fighting bladder cancer," said Elon Ganor, Nucleix's co-founder and CEO, "These results show best-in-class performance for Bladder EpiCheck and will strongly support our launch in Europe."
Nucleix develops non-invasive molecular cancer diagnostic tests based on identification of subtle epigenetic changes in methylation patterns. Nucleix technology is based on a combination of a new biochemical assay in conjunction with sophisticated algorithms. The Nucleix pipeline includes a screening diagnostic blood test for early lung cancer detection.
Latest Molecular Diagnostics News
- Blood Test Accurately Predicts Lung Cancer Risk and Reduces Need for Scans
- Unique Autoantibody Signature to Help Diagnose Multiple Sclerosis Years before Symptom Onset
- Blood Test Could Detect HPV-Associated Cancers 10 Years before Clinical Diagnosis
- Low-Cost Point-Of-Care Diagnostic to Expand Access to STI Testing
- 18-Gene Urine Test for Prostate Cancer to Help Avoid Unnecessary Biopsies
- Urine-Based Test Detects Head and Neck Cancer
- Blood-Based Test Detects and Monitors Aggressive Small Cell Lung Cancer
- Blood-Based Machine Learning Assay Noninvasively Detects Ovarian Cancer
- Simple PCR Assay Accurately Differentiates Between Small Cell Lung Cancer Subtypes
- Revolutionary T-Cell Analysis Approach Enables Cancer Early Detection
- Single Genetic Test to Accelerate Diagnoses for Rare Developmental Disorders
- Upgraded Syndromic Testing Analyzer Enables Remote Test Results Access
- Respiratory and Throat Infection PCR Test Detects Multiple Pathogens with Overlapping Symptoms
- Blood Circulating Nucleic Acid Enrichment Technique Enables Non-Invasive Liver Cancer Diagnosis
- First FDA-Approved Molecular Test to Screen Blood Donors for Malaria Could Improve Patient Safety
- Fluid Biomarker Test Detects Neurodegenerative Diseases Before Symptoms Appear