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
Platinum Member
Automated Coagulation Analyzer
Hemolumi H6
New
Gold Member
Serum Indices Control
Acusera Serum Indices Control
Urine Analyzer
respons® UDS100
Automatic CLIA Analyzer
Shine i6000
Latest Industry News
- Diazyme Expands Chemistry Testing Portfolio With Alfa Wassermann Acquisition
- Agilent Acquisition of Proscia to Advance AI-Enabled Digital Pathology Workflows
- Digital Pathology Collaboration Expands Laboratory Access to AI-Driven Diagnostics
- Multi-Cancer Screening Blood Test Gains FDA Breakthrough Designation
- European Approval Expands Liquid Biopsy Use in Advanced Breast Cancer Testing
- Regulatory Milestone Expands Access to Blood-Based Neurology Biomarker Testing in China
- Collaboration Advances Automated Benchtop Platform for Routine Blood Testing
- Expanded Partnership Supports AI Biomarker Validation and Clinical Trial Deployment
- Multi-Cancer Early Detection Test Wins FDA Panel Backing for Approval
- Mayo Clinic Laboratories and Pathology Asia Expand Genomic Testing Across Asia-Pacific
- Collaboration Combines AI Cognitive Assessment and RNA Blood Testing for Earlier Alzheimer’s Detection
- New UK Collaboration Expands Access to Integrated Alzheimer’s Diagnostic Testing
- Siemens Healthineers and Novo Collaborate to Expand Access to Noninvasive Liver Testing
- Mayo Clinic and Thermo Fisher Launch Multi-Omics Venture to Identify Early Disease Signals
- Sputum-Based Lung Cancer Test Technology Granted Hong Kong Patent
- Veracyte Acquisition Expands Urine-Based Bladder Cancer Monitoring Capabilities
Channels
Clinical Chemistry
view channel
Blood Protein May Help Identify Treatment-Resistant Psychosis
Psychotic disorders, including schizophrenia, are diagnosed primarily through assessment of symptoms and behaviors such as hallucinations, delusions, and disordered thinking. Treatment-resistant psychosis... Read more
Electrochemical Biosensor Rapidly Detects Cerebrospinal Fluid Leaks
Cerebrospinal fluid surrounds the brain and spinal cord and helps protect them from physical impact. After severe head trauma or brain surgery, it can leak through skull defects and drain from the nose or ears.... Read more
Molecular Diagnostics
view channel
New RNA Detection Tool Shows Promise for HIV and Other Viral Testing
RNA viruses such as human immunodeficiency virus (HIV) require assays that can detect very low levels of viral genetic material. Clinical and environmental testing can also expose enzymes to harsh assay... Read more
Tissue-Specific Vesicle Isolation Expands Molecular Insights Into Liver Disease
Liver disease can produce overlapping molecular signals from cirrhosis and hepatocellular carcinoma, complicating blood-based analysis. Liquid biopsy approaches that examine extracellular vesicles face... Read more
Hematology
view channel
New Donor Genetic Marker May Help Predict Stem Cell Transplant Success
Donor selection for hematopoietic stem cell transplantation plays a major role in relapse risk and survival for patients with blood cancers and other blood disorders. Despite advances in genotyping, uncertainty... Read more
Updated Ferritin Thresholds Improve Detection of Iron Deficiency
Iron deficiency is one of the most common health conditions worldwide, yet its nonspecific symptoms can delay diagnosis for months. Variation in testing practices and ferritin thresholds may contribute... Read more
Immunology
view channel
FDA Approval Adds Automated Testing Option for Parvovirus B19 Serology
Human Parvovirus B19 is a highly contagious erythrovirus transmitted mainly through respiratory droplets and close contact. Diagnosis relies on IgM antibodies to detect active infection and IgG antibodies... Read more
Blood-Based Immune Aging Map Could Help Spot Disease Risk Earlier
Chronological age does not always reflect immune health or future disease risk. Two adults of the same age can have immune systems that age very differently, with some remaining resilient while others... Read more
Microbiology
view channel
Oral and Lung Microbiome Changes Linked to Severe Long Covid Symptoms
Long Covid can involve persistent respiratory, cognitive, and gastrointestinal symptoms after acute infection, creating a difficult diagnostic and management challenge. Because COVID-19 initially affects... Read more
Study Finds Distinct Malaria Parasites Linked to Sickle Cell Trait Protection
Malaria remains one of the world’s deadliest infectious diseases and has affected humans throughout recorded history. In regions where malaria is common, human genetics have been shaped by the sickle cell... Read more
Rapid Urine Test Aids Diagnosis of Invasive Aspergillosis
Invasive aspergillosis is an uncommon mold infection in the general population but can pose serious risks for people with weakened immune defenses. Diagnosis can be difficult because existing approaches... Read more
Nanodroplet CRISPR Technology Supports Rapid, Multiplexed Mycobacterial Identification
Mycobacterial infections are difficult to diagnose because closely related species can have different clinical and therapeutic implications. Nontuberculous mycobacteria (NTM) are increasingly recognized... Read morePathology
view channel
Molecular Testing Refines Barrett’s Esophagus Progression Risk Beyond Biopsy Findings
Barrett’s esophagus is a precancerous condition associated with increased risk of esophageal adenocarcinoma. Routine endoscopic biopsy findings guide surveillance and therapy, but histopathology may not... Read more
AI Histopathology Tool Distinguishes Ewing Sarcoma for Diagnosis
Ewing sarcoma is a rare malignant tumor that mainly affects children, adolescents, and young adults. It usually arises in bone but can also develop in soft tissue, where its microscopic appearance may... Read more
Rapid Mass Spectrometry Test May Aid Glioma Margin Decisions
Glioma brain tumors are highly infiltrative and can extend into nearby healthy brain tissue, making tumor margins difficult to define during surgery. Residual tumor cells may contribute to recurrence and... Read more
Genomic Classifier Predicts Benefit From Adding Hormone Therapy to Salvage Prostate Radiation
Men who have undergone prostatectomy for prostate cancer may later develop a detectable or rising prostate-specific antigen, prompting salvage radiation therapy. A key challenge is determining who is most... Read moreTechnology
view channel
Laser-Based Swab Analysis Shows Promise for Detecting Disease-Linked Odor Patterns
Disease-related changes in volatile organic compounds can alter body odor, producing measurable patterns in exhaled breath and bodily fluids. Current analytical methods can be complex, time-consuming,... Read more
