QuidelOrtho and BÜHLMANN Launch Rapid Gastrointestinal Biomarker Assays for IBD and Pancreatic Insufficiency Diagnosis
Key Insights
QuidelOrtho Corporation (search) and BÜHLMANN Laboratories AG have announced the availability of fCAL turbo (search) and fPELA turbo (search) assays on VITROS Systems for rapid gastrointestinal biomarker testing.
The fCAL turbo (search) assay aids in diagnosing inflammatory bowel disease (search) and differentiating it from irritable bowel syndrome (search), while the fPELA turbo (search) assay helps determine pancreatic insufficiency (search).
Both particle-enhanced turbidimetric immunoassays deliver results in less than 10 minutes and feature 90-day on-analyzer stability with simplified sample preparation using CALEX Cap technology.
QuidelOrtho Corporation (search) and BÜHLMANN Laboratories AG have announced the commercial availability of two gastrointestinal biomarker assays on QuidelOrtho's VITROS Systems, marking a significant advancement in non-invasive diagnostic capabilities for inflammatory bowel disease (search) (IBD (search)) and pancreatic insufficiency (search).
Dual Assay Platform for Gastrointestinal Diagnostics
The collaboration introduces the BÜHLMANN fCAL turbo (search) and fPELA turbo (search) assays as MicroTip Partnership Assays (MPA) on VITROS Systems. Both particle-enhanced turbidimetric immunoassays target distinct clinical applications: the fCAL turbo assay measures fecal calprotectin (search) to aid in IBD (search) diagnosis and its differentiation from irritable bowel syndrome (search), while the fPELA turbo assay measures fecal pancreatic elastase (search) to determine pancreatic insufficiency (search).
The assays are available on multiple VITROS platforms, including the VITROS XT 7600 and 5600 Integrated Systems, as well as VITROS 4600 Chemistry Systems, providing laboratories with flexible implementation options across their existing infrastructure.
Rapid Results and Enhanced Workflow Efficiency
The new assays deliver results in less than 10 minutes, representing a significant improvement in diagnostic turnaround time for gastrointestinal conditions. Additional technical features include wide reportable ranges, 90-day on-analyzer stability, and compatibility with VITROS Automation Solutions.
"The integration of BÜHLMANN's fCAL and fPELA turbo (search) assays with our VITROS Systems represents a significant advancement in IBD (search) and pancreatic insufficiency (search) diagnoses," said Jonathan Siegrist, PhD, Executive Vice President of Research & Development & Chief Technology Officer at QuidelOrtho. "This collaboration allows laboratories to provide fast results to aid in the diagnosis and management of IBD and pancreatic issues."
Innovative Sample Preparation Technology
Both assays utilize BÜHLMANN's CALEX Cap technology, which simplifies sample extraction and preparation while facilitating safe handling. The technology optimizes stool extraction efficiency to maximize stability and yield, resulting in robust fecal calprotectin (search) and pancreatic elastase test results. The system allows laboratories to use CALEX Cap-prepared stool samples directly on the VITROS platform.
"Our assays, combined with the CALEX Cap stool preparation device, optimize stool extraction efficiency to help maximize stability and yield," said Christian Eberle, Chief Executive Officer at BÜHLMANN Laboratories AG. "This collaboration between QuidelOrtho and BÜHLMANN Laboratories AG meets evolving patient and provider needs in the era of personalized medicine and preventive healthcare."
Addressing Healthcare Trends and Clinical Needs
The collaboration addresses key healthcare trends, including the rise of non-invasive diagnostic tools, the demand for cost-effective healthcare solutions, and the growing focus on gastrointestinal and pancreatic health and its systemic impact. The assays contribute to better management of gastrointestinal health, reducing the need for invasive procedures and lowering long-term healthcare costs.
The integration offers laboratories an efficient workflow for a wide variety of sample collection methods, enhancing flexibility in sample handling and processing. The solution combines clinical accuracy with operational efficiency, supporting the shift toward tailored medicine and preventive healthcare approaches.