Latest news with #NordicBioscience
Cision Canada
16-05-2025
- Health
- Cision Canada
Nordic Bioscience launches novel Endotrophin assay
HERLEV, Denmark, May 16, 2025 /CNW/ -- Nordic Bioscience introduces nordicEndotrophin™, a fully automated high-precision assay that selectively quantifies the intact 77-amino-acid Endotrophin signaling hormone—qualified in the CAP/CLIA certified Nordic Bioscience laboratory. When integrated with the company's existing product line, the biomarker assay demonstrated prognostic utility in fibrosis and cancer studies 1. NordicEndotrophin™ joins nordicPRO-C6™ and nordicPRO-C3™ (in-house versions of the FDA-supported PRO-C6 and CE approved PRO-C3 assays) to deliver a one-stop solution for assessing the fibro-inflammatory axis in chronic diseases, including cardiovascular, metabolic, renal and more. Following PRO-C3's recent deployment on Roche IVD platforms, the new Endotrophin assay strengthens risk stratification and pharmacodynamic monitoring. Endotrophin was first identified in 2012 as a collagen-derived hormone released from type VI collagen. Type VI collagen is a contributor to fibroblast activation and driver of fibrosis across organs—inflammatory processes that underlie roughly 40 percent of deaths in Western countries 2. Obesity exacerbates this by activating fibroblasts in the liver, kidney and heart. Across a range of chronic diseases, patients with a two-fold increase of circulating Endotrophin levels increased risk of mortality by 100% 1,2. Quantifying Endotrophin enables researchers to connect wound healing and fibrotic progression to patient outcomes, supporting precision-medicine approaches that pharmacodynamically modulate this dangerous hormone. Whereas PRO-C6, Nordic Bioscience's first hand-held ELISA assay measuring the formation of the total pool of type VI collagen (a3 chain encompassing 12 Von Willebrand binding domains), a collagen responsible for binding of platelets that cause fibroblast activation and would healing, nordicEndotrophin™ specifically measures the intact 77-amino-acid hormone. This specificity means additional risk stratification and prognostic value that complement PRO-C6's fibrosis-driven pharmacodynamic insights 1. " Endotrophin is a significant prognostic biomarker to emerge," said CEO Dr. Morten Karsdal. " Evidenced in a study of HFpEF patients, Endotrophin and PRO-C6 outperformed NT-proBNP in HFpEF for mortality and hospitalization risk 3. Together with PRO-C3, quantifying this fibro-inflammatory hormone will refine patient stratification and treatment monitoring across obesity, fibrotic diseases, and autoimmune endotypes." Offered in Nordic Bioscience's CAP/CLIA-certified laboratory in Herlev, Denmark, the nordicEndotrophin™ high-precision sandwich assay is available on fully automated, high-accuracy, high-throughput platforms. To accelerate drug fibro-inflammatory profiling, clients considering nordicEndotrophin™ are invited to co-measure nordicPRO-C3™ and nordicPRO-C6™. Together, these assays facilitate precise risk stratification, dose selection, patient enrichment, proof-of-mechanism and treatment monitoring in anti-fibrotic and oncology trials 2. About Nordic Bioscience Nordic Bioscience is a Danish biomarker company headquartered in Herlev, Denmark. We are engaged in biomarker development using our unique neoepitope technology. We combine our expertise in biomarker development with preclinical and clinical research. This enables us to develop biomarkers that provide fast and objective decision-making for compound selection and development in clinical trials as well as provide value for patients in a diagnostic setting. For more information about Nordic Bioscience, visit us at [2] [3] SOURCE Nordic Bioscience
Yahoo
16-05-2025
- Health
- Yahoo
Nordic Bioscience launches novel Endotrophin assay
HERLEV, Denmark, May 16, 2025 /CNW/ -- Nordic Bioscience introduces nordicEndotrophin™, a fully automated high-precision assay that selectively quantifies the intact 77-amino-acid Endotrophin signaling hormone—qualified in the CAP/CLIA certified Nordic Bioscience laboratory. When integrated with the company's existing product line, the biomarker assay demonstrated prognostic utility in fibrosis and cancer studies1. NordicEndotrophin™ joins nordicPRO-C6™ and nordicPRO-C3™ (in-house versions of the FDA-supported PRO-C6 and CE approved PRO-C3 assays) to deliver a one-stop solution for assessing the fibro-inflammatory axis in chronic diseases, including cardiovascular, metabolic, renal and more. Following PRO-C3's recent deployment on Roche IVD platforms, the new Endotrophin assay strengthens risk stratification and pharmacodynamic monitoring. Endotrophin was first identified in 2012 as a collagen-derived hormone released from type VI collagen. Type VI collagen is a contributor to fibroblast activation and driver of fibrosis across organs—inflammatory processes that underlie roughly 40 percent of deaths in Western countries2. Obesity exacerbates this by activating fibroblasts in the liver, kidney and heart. Across a range of chronic diseases, patients with a two-fold increase of circulating Endotrophin levels increased risk of mortality by 100%1,2. Quantifying Endotrophin enables researchers to connect wound healing and fibrotic progression to patient outcomes, supporting precision-medicine approaches that pharmacodynamically modulate this dangerous hormone. Whereas PRO-C6, Nordic Bioscience's first hand-held ELISA assay measuring the formation of the total pool of type VI collagen (a3 chain encompassing 12 Von Willebrand binding domains), a collagen responsible for binding of platelets that cause fibroblast activation and would healing, nordicEndotrophin™ specifically measures the intact 77-amino-acid hormone. This specificity means additional risk stratification and prognostic value that complement PRO-C6's fibrosis-driven pharmacodynamic insights1. "Endotrophin is a significant prognostic biomarker to emerge," said CEO Dr. Morten Karsdal. "Evidenced in a study of HFpEF patients, Endotrophin and PRO-C6 outperformed NT-proBNP in HFpEF for mortality and hospitalization risk3. Together with PRO-C3, quantifying this fibro-inflammatory hormone will refine patient stratification and treatment monitoring across obesity, fibrotic diseases, and autoimmune endotypes." Offered in Nordic Bioscience's CAP/CLIA-certified laboratory in Herlev, Denmark, the nordicEndotrophin™ high-precision sandwich assay is available on fully automated, high-accuracy, high-throughput platforms. To accelerate drug fibro-inflammatory profiling, clients considering nordicEndotrophin™ are invited to co-measure nordicPRO-C3™ and nordicPRO-C6™. Together, these assays facilitate precise risk stratification, dose selection, patient enrichment, proof-of-mechanism and treatment monitoring in anti-fibrotic and oncology trials2. About Nordic Bioscience Nordic Bioscience is a Danish biomarker company headquartered in Herlev, Denmark. We are engaged in biomarker development using our unique neoepitope technology. We combine our expertise in biomarker development with preclinical and clinical research. This enables us to develop biomarkers that provide fast and objective decision-making for compound selection and development in clinical trials as well as provide value for patients in a diagnostic setting. For more information about Nordic Bioscience, visit us at References: [1] [2] [3] For product related inquires please use Logo: View original content to download multimedia: SOURCE Nordic Bioscience View original content to download multimedia: Sign in to access your portfolio
Cision Canada
08-05-2025
- Health
- Cision Canada
Nordic Bioscience announces PRO-C3 launched by Roche Diagnostics on cobas analysers
HERLEV, Denmark , May 8, 2025 /CNW/ -- Nordic Bioscience announces that its PRO-C3 test is launched by Roche Diagnostics on their cobas analysers. The Roche Elecsys® PRO-C3, used with the ADAPT formula (age, diabetes status, PRO-C3, platelets), assesses liver fibrosis severity – a disease responsible for approximately one in every 25 deaths worldwide. The nordicPRO-C3™ biomarker is already validated in Nordic Bioscience CAP-CLIA certified laboratory in Denmark. This demonstrates that Nordic Bioscience is dedicated to helping patients in a precision medicine driven approach, and our Platform provides the quality needed for regulatory approval. Nordic Bioscience's scientists have over that last 10 years published more than 250 scientific papers on PRO-C3 making us the leading place for research within PRO-C3 and fibrotic related diseases. PRO-C3 is the first of the Nordic Bioscience-biomarkers from our fibrosis panel which has been CE-approved. 40% of deaths in the western world are associated with alterations of organs such as the liver, and we provide the tools to quantify this. These are the tools of modern clinical chemistry. " The Elecsys PRO-C3 test is the first test launched from the collaboration between Nordic Bioscience and Roche Diagnostics. We are proud that our technology becomes globally available to make a difference for patients." said Morten Karsdal, CEO of Nordic Bioscience. About PRO-C3 PRO-C3 was invented by Nordic Bioscience and has up until now been available as a service performed in Nordic Bioscience's laboratory in Denmark using the nordicPRO-C3™ test. The Elecsys PRO-C3 test is developed under a license agreement between Nordic Bioscience and Roche Diagnostics. For more information including scientific information on PRO-C3 see About Nordic Bioscience Nordic Bioscience is a Danish biomarker company headquartered in Herlev, Denmark. We are engaged in biomarker development using our unique neoepitope technology. We combine our expertise in biomarker development with preclinical and clinical research. This enables us to develop biomarkers that provide fast and objective decision-making for compound selection and development in clinical trials as well as provide value for patients in a diagnostic setting. For more information about Nordic Bioscience, visit us at SOURCE Nordic Bioscience
Yahoo
06-05-2025
- Health
- Yahoo
Roche introduces innovative Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity
F. Hoffmann-La Roche Ltd Elecsys PRO-C3, used with the ADAPT formula (age, diabetes status, PRO-C3, platelets), assesses liver fibrosis severity – a disease responsible for approximately one in every 25 deaths worldwide 1 The test delivers results in just 18 minutes on Roche's cobas analysers, providing a fast and reliable diagnostic method. The test enables earlier identification of patients with significant liver fibrosis, potentially improving outcomes through timely management and access to emerging therapies. Basel, 06 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of its Elecsys® PRO-C3 test, a new diagnostic solution designed to assess the severity of liver fibrosis in patients showing signs of metabolic dysfunction–associated steatotic liver disease (MASLD). The test, developed in partnership with Nordic Bioscience, offers clinicians a simple and efficient method of identifying patients with liver fibrosis of varying severity, enabling timely intervention and appropriate management of the disease. MASLD affects around 30% of the population,2 and is one of the most common causes of chronic liver disease in the developed world.3 Caused mainly by diabetes, obesity and other cardiometabolic risk factors,3 a rapidly growing number of people are living with MASLD, representing a significant burden for patients and health systems worldwide. However, despite being responsible for approximately one in every 25 deaths globally,1 the liver fibrosis associated with MASLD is often asymptomatic until the advanced stages and can go undetected for years. Unmanaged, it can lead to severe consequences such as cirrhosis, liver cancer, and liver failure. "The Elecsys PRO-C3 test addresses an urgent need in the diagnosis, staging and management of liver fibrosis," said Matt Sause, CEO of Roche Diagnostics. "With MASLD affecting a growing number of people worldwide and new treatments emerging, it is critical to detect fibrosis accurately and early. Our innovative solution simplifies the diagnostic process and eases the burden on healthcare services, providing a clear and rapid assessment while reducing the requirement for invasive biopsies." Until recently, no medicines were available to treat MASLD, and disease management options were focused on lifestyle interventions such as diet and exercise. New drug treatments for liver fibrosis are now emerging, giving clinicians, for the first time, a means of improving liver function and slowing disease progression. The Elecsys PRO-C3 test requires only a single assay, which delivers results in only 18 minutes on Roche's cobas® analysers. This streamlines the process compared to currently available tests and reduces costs. Used in combination with the ADAPT formula,4 which includes PRO-C3 levels, platelet count, age and diabetes status, it provides a clear assessment of the severity of fibrosis, including distinguishing between different severities such as significant fibrosis (≥F2), advanced fibrosis (≥F3), and cirrhosis (F4). This is crucial for determining the appropriate treatment pathway for patients and identifying those who are eligible for new and emerging therapies.
