Partners to Develop and Commercialize Noninvasive Tests for Bladder Cancer
|
By LabMedica International staff writers Posted on 30 Aug 2015 |
|
An agreement between a major European university medical center and a multinational biotechnology company was designed to promote commercialization and further development of a liquid biopsy test for the diagnosis of bladder cancer.
The liquid biopsy test is based on bladder cancer DNA methylation biomarkers developed by MDxHealth SA (Herstal, Belgium) and at the University Erasmus Medical Center (Rotterdam, The Netherlands). MDxHealth has now signed an exclusive worldwide biomarker license and scientific collaboration agreement with the University Erasmus Medical Center granting MDxHealth exclusive worldwide rights for the use of a number of its bladder cancer DNA methylation biomarkers for both laboratory tests as well as in vitro diagnostic (IVD) products. University Erasmus Medical Center will receive upfront and milestone payments and royalties on net sales on any commercialized products. The two organizations have also agreed to collaborate in the clinical development of this and future bladder cancer tests.
Current diagnostic tools for the detection of bladder cancer are invasive and, with a sensitivity limited to only about 70%, leave many patients at risk of having undetected cancer. The MDxHealth liquid biopsy was designed to rule-out bladder cancer in patients with hematuria (blood in urine) noninvasively. It is based on DNA biomarkers that become modified by cancer cells. The liquid biopsy identifies these modifications at the genetic level providing the physicians with a tool to aid in the diagnosis of cancer, assess the risk of recurrence or metastasis of the cancer, and predict an individual patient’s likely response to cancer treatment.
Preliminary data from clinical trials conducted by the partners is due to be reported at the September 9–11, 2015, 11th World Congress on Urological Research that will be held in Nijmegen (The Netherlands). A cohort of 154 patients with hematuria, were tested, and it was found that the liquid biopsy urine test for bladder cancer had a negative predictive value (NPV) of 98.3%.
Dr. Jan Groen, CEO of MDxHealth, said, "Critical to our strategy is the discovery and development of noninvasive tests for urological disease. These positive data lead us to be confident that we could launch a urine based, “liquid biopsy” testing solution that will provide physicians a cost-effective, patient-friendly test to accurately aid bladder cancer detection and recurrence monitoring. We are delighted to be working alongside University Erasmus Medical Center and look forward to initiating a larger evaluation study in bladder cancer patients in due course.”
Dr. Ellen Zwarthoff, a professor at University Erasmus Medical Center, said, “Bladder cancer is the fifth most common cancer in the western world, and will continue to cost many lives unless we identify new approaches to diagnose it early, at its most treatable stages.”
Related Links:
MDxHealth SA
University Erasmus Medical Center
The liquid biopsy test is based on bladder cancer DNA methylation biomarkers developed by MDxHealth SA (Herstal, Belgium) and at the University Erasmus Medical Center (Rotterdam, The Netherlands). MDxHealth has now signed an exclusive worldwide biomarker license and scientific collaboration agreement with the University Erasmus Medical Center granting MDxHealth exclusive worldwide rights for the use of a number of its bladder cancer DNA methylation biomarkers for both laboratory tests as well as in vitro diagnostic (IVD) products. University Erasmus Medical Center will receive upfront and milestone payments and royalties on net sales on any commercialized products. The two organizations have also agreed to collaborate in the clinical development of this and future bladder cancer tests.
Current diagnostic tools for the detection of bladder cancer are invasive and, with a sensitivity limited to only about 70%, leave many patients at risk of having undetected cancer. The MDxHealth liquid biopsy was designed to rule-out bladder cancer in patients with hematuria (blood in urine) noninvasively. It is based on DNA biomarkers that become modified by cancer cells. The liquid biopsy identifies these modifications at the genetic level providing the physicians with a tool to aid in the diagnosis of cancer, assess the risk of recurrence or metastasis of the cancer, and predict an individual patient’s likely response to cancer treatment.
Preliminary data from clinical trials conducted by the partners is due to be reported at the September 9–11, 2015, 11th World Congress on Urological Research that will be held in Nijmegen (The Netherlands). A cohort of 154 patients with hematuria, were tested, and it was found that the liquid biopsy urine test for bladder cancer had a negative predictive value (NPV) of 98.3%.
Dr. Jan Groen, CEO of MDxHealth, said, "Critical to our strategy is the discovery and development of noninvasive tests for urological disease. These positive data lead us to be confident that we could launch a urine based, “liquid biopsy” testing solution that will provide physicians a cost-effective, patient-friendly test to accurately aid bladder cancer detection and recurrence monitoring. We are delighted to be working alongside University Erasmus Medical Center and look forward to initiating a larger evaluation study in bladder cancer patients in due course.”
Dr. Ellen Zwarthoff, a professor at University Erasmus Medical Center, said, “Bladder cancer is the fifth most common cancer in the western world, and will continue to cost many lives unless we identify new approaches to diagnose it early, at its most treatable stages.”
Related Links:
MDxHealth SA
University Erasmus Medical Center
Gold Member
Quantitative POC Immunoassay Analyzer
EASY READER+
New
Gold Member
STI Test
Vivalytic MG, MH, UP/UU
New
Gold Member
Aspiration System
VACUSAFE
Latest Industry News
- Automated MSI Test Gains IVDR Certification to Guide CRC Therapy
- New Partnership Brings Alzheimer’s Blood Biomarker Test to Community Screening Network
- MGI Tech Strengthens Sequencing Portfolio with Dual Acquisition
- Agilent Technologies Acquires Pathology Diagnostics Company Biocare Medical
- Cepheid Joins CDC Initiative to Strengthen U.S. Pandemic Testing Preparednesss
- QuidelOrtho Collaborates with Lifotronic to Expand Global Immunoassay Portfolio
- WHX Labs in Dubai spotlights leadership skills shaping next-generation laboratories
- AI-Powered Cervical Cancer Test Set for Major Rollout in Latin America
- New Collaboration Brings Automated Mass Spectrometry to Routine Laboratory Testing
- Diasorin and Fisher Scientific Enter into US Distribution Agreement for Molecular POC Platform
- WHX Labs Dubai to Gather Global Experts in Antimicrobial Resistance at Inaugural AMR Leaders’ Summit
- BD and Penn Institute Collaborate to Advance Immunotherapy through Flow Cytometry
- Abbott Acquires Cancer-Screening Company Exact Sciences
- Roche and Freenome Collaborate to Develop Cancer Screening Tests
- Co-Diagnostics Forms New Business Unit to Develop AI-Powered Diagnostics
- Qiagen Acquires Single-Cell Omics Firm Parse Biosciences
Channels
Clinical Chemistry
view channel
Routine Blood Markers Predict Heart Failure Risk in Prediabetes
Heart failure prevention relies on finding high-risk adults before symptoms appear, yet effective stratification remains difficult in routine care. Prediabetes affects an estimated 115.2 million U.... Read more
First IVD Immunoassay to Detect Alzheimer’s Risk Gene Variant Receives CE Mark
Alzheimer’s disease accounts for up to 70% of dementia cases worldwide and is projected to affect nearly 150 million people by 2050, underscoring the need for scalable, accessible diagnostics.... Read more
Molecular Diagnostics
view channel
Liquid Biopsy Method Pinpoints Disease Source From a Single Drop of Blood
Liquid biopsy offers a noninvasive way to assess disease, but many assays still lack reliable tissue-of-origin localization and robust performance for early cancer detection. Researchers now report a method... Read more
Study Reveals Widespread Errors in Gene Variant Naming
Accurate variant nomenclature underpins the ability of clinical laboratories to retrieve and interpret evidence for rare disease diagnosis. Yet many patients face prolonged diagnostic journeys; in the U.... Read more
Hematology
view channel
Rapid Cartridge-Based Test Aims to Expand Access to Hemoglobin Disorder Diagnosis
Sickle cell disease and beta thalassemia are hemoglobin disorders that often require referral to specialized laboratories for definitive diagnosis, delaying results for patients and clinicians.... Read more
New Guidelines Aim to Improve AL Amyloidosis Diagnosis
Light chain (AL) amyloidosis is a rare, life-threatening bone marrow disorder in which abnormal amyloid proteins accumulate in organs. Approximately 3,260 people in the United States are diagnosed... Read more
Immunology
view channel
Cancer Mutation ‘Fingerprints’ to Improve Prediction of Immunotherapy Response
Cancer cells accumulate thousands of genetic mutations, but not all mutations affect tumors in the same way. Some make cancer cells more visible to the immune system, while others allow tumors to evade... Read more
Immune Signature Identified in Treatment-Resistant Myasthenia Gravis
Myasthenia gravis is a rare autoimmune disorder in which immune attack at the neuromuscular junction causes fluctuating weakness that can impair vision, movement, speech, swallowing, and breathing.... Read more
New Biomarker Predicts Chemotherapy Response in Triple-Negative Breast Cancer
Triple-negative breast cancer is an aggressive form of breast cancer in which patients often show widely varying responses to chemotherapy. Predicting who will benefit from treatment remains challenging,... Read more
Blood Test Identifies Lung Cancer Patients Who Can Benefit from Immunotherapy Drug
Small cell lung cancer (SCLC) is an aggressive disease with limited treatment options, and even newly approved immunotherapies do not benefit all patients. While immunotherapy can extend survival for some,... Read moreMicrobiology
view channel
Study Highlights Accuracy Gaps in Consumer Gut Microbiome Kits
Direct-to-consumer gut microbiome kits promise personalized insights by profiling fecal bacteria and generating health readouts, but their analytical accuracy remains uncertain. A new study shows that... Read more
WHO Recommends Near POC Tests, Tongue Swabs and Sputum Pooling for TB Diagnosis
Tuberculosis (TB) remains one of the world’s leading infectious disease killers, yet millions of cases go undiagnosed or are detected too late. Barriers such as reliance on sputum samples, limited laboratory... Read more
Pathology
view channel
AI-Powered Tool to Transform Dermatopathology Workflow
Skin cancer accounts for the largest number of cancer diagnoses in the United States, placing sustained pressure on pathology services. Diagnostic interpretation can be variable for challenging melanocytic... Read more
New Chromogenic Culture Media Enable Rapid Detection of Candida Infections
Invasive Candida infections are challenging for healthcare systems, with some strains spreading rapidly in hospitals and showing resistance to multiple antifungal drugs. Candida auris is associated with... Read more
Technology
view channel
New Electronic Pipette Enhances Workflows with Touchscreen Control
Manual pipetting remains a routine yet error-prone step that can affect reproducibility and throughput in clinical and research laboratories. Training demands and ergonomic strain also add variability... Read more
AI Model Outperforms Clinicians in Rare Disease Detection
Rare diseases affect an estimated 300 million people worldwide, yet diagnosis is often protracted and error-prone. Many conditions present with heterogeneous signs that overlap with common disorders, leading... Read more
