Gastrointestinal biomarker tests enhance patient diagnosis of IBD and pancreatic insufficiency on leading clinical chemistry platforms

SAN DIEGO , July 14, 2025 /PRNewswire/ -- QuidelOrtho Corporation (Nasdaq: QDEL) ("QuidelOrtho") and BÜHLMANN Laboratories AG today announced the availability of the BÜHLMANN fCAL turbo and fPELA turbo assays on QuidelOrtho's VITROS Systems as an MPA. Both particle-enhanced turbidimetric immunoassays, the fCAL turbo assay for fecal calprotectin measurement aids in the diagnosis of inflammatory bowel disease (IBD) and its differentiation from irritable bowel syndrome, and the fPELA turbo assay for fecal pancreatic elastase aids in the determination of pancreatic insufficiency.

This 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 fCAL and fPELA turbo assays exemplify innovation in diagnostics technology, supporting the shift toward tailored medicine and preventive healthcare.

The fCAL and fPELA turbo assays are both now available for use on QuidelOrtho's VITROS Systems (fCAL turbo and fPELA turbo assays – U.S. and Outside U.S.: VITROS XT 7600 and 5600 Integrated System, as well as VITROS 4600 Chemistry Systems.

Key features include:

• Rapid results in less than 10 minutes
• Wide reportable ranges
• 90-day on-analyzer stability
• Compatibility with VITROS Automation Solutions
• Simplified sample extraction and preparation with CALEX® Cap technology

"The integration of BÜHLMANN's fCAL and fPELA turbo assays with our VITROS Systems represents a significant advancement in IBD and pancreatic insufficiency 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. With features like the long calibration interval and the ability to use the CALEX Cap–prepared stool samples directly, we're offering a solution that combines clinical accuracy with operational efficiency, ultimately improving patient care."

These assays contribute to better management of gastrointestinal health, reducing the need for invasive procedures and lowering long-term healthcare costs.

Both assays utilize BÜHLMANN's innovative CALEX Cap technology, which simplifies sample extraction and preparation while facilitating safe handling – all seamlessly integrated onto a single VITROS System.

"We are thrilled to collaborate with QuidelOrtho to expand the delivery of an efficient, automated solution for fecal biomarker testing," said Christian Eberle, Chief Executive Officer at BÜHLMANN Laboratories AG. "Our assays, combined with the CALEX Cap stool preparation device, optimize stool extraction efficiency to help maximize stability and yield, resulting in robust fecal calprotectin and pancreatic elastase test results. This collaboration between QuidelOrtho and BÜHLMANN Laboratories AG meets evolving patient and provider needs in the era of personalized medicine and preventive healthcare, offering innovative solutions that align with the industry's focus on non-invasive, cost-effective, and patient-centric diagnostic tools."

The fCAL and fPELA turbo assays' integration with VITROS Systems offers laboratories an efficient workflow for a wide variety of sample collection methods, enhancing flexibility in sample handling and processing.

*CALEX, fCAL and fPELA are trademarks of BÜHLMANN Laboratories AG and VITROS and MicroTip are trademarks of QuidelOrtho.

QuidelOrtho is dedicated to advancing diagnostics to power a healthier future. For more information, please visit quidelortho.com and follow QuidelOrtho on LinkedIn, Facebook and X.

About QuidelOrtho Corporation

QuidelOrtho Corporation (Nasdaq: QDEL) is a world leader in in vitro diagnostics, developing and manufacturing intelligent solutions that transform data into understanding and action for more people in more places every day.

Offering industry-leading expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, bringing fast, accurate and reliable diagnostics when and where they are needed – from home to hospital, lab to clinic. 

Building on its long history of innovation, QuidelOrtho works with global healthcare customers to advance diagnostics, where insights and solutions seamlessly connect, illuminating a clearer path for informed decisions.

About BÜHLMANN Laboratories AG

BÜHLMANN Laboratories AG has been discovering, developing & manufacturing innovative chemistry and immunological in-vitro diagnostic (IVD) and research use only (RUO) assays for almost 50 years (circa 1976).

About BUHLMANN Diagnostics Corp (BDC)

As the United States commercial affiliate of BÜHLMANN Laboratories AG, BUHLMANN Diagnostics Corp (BDC), based in Amherst, NH, is committed to providing exceptional sales, support, and technical services to our clinical discovery and basic science research laboratory customers.

Investor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@QuidelOrtho.com

Media Contact:
D. Nikki Wheeler
Senior Director, Corporate Communications
media@QuidelOrtho.com

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SOURCE QuidelOrtho Corporation