SALEM, N.H. – ALPCO has launched its Calprotectin Immunoturbidimetric Assay in Europe, marking a significant expansion of its gastrointestinal diagnostic solutions. The test, which received FDA clearance in 2023, helps differentiate inflammatory bowel disease (IBD) from irritable bowel syndrome (IBS) with 90.5% sensitivity and 93.4% specificity.
Streamlining IBD Diagnosis
The assay enables healthcare providers to prioritize patients for colonoscopy more efficiently, reducing unnecessary procedures through its high diagnostic accuracy. By distinguishing IBD from IBS with minimal false positives, the test supports faster clinical decision-making and more targeted patient care pathways.
Automated Testing in Development
Concurrently, ALPCO has enrolled its first patient in a pivotal U.S. trial for an automated chemiluminescent version of the calprotectin assay. Designed for the KleeYa™ system, this advancement promises to deliver greater efficiency for clinical laboratories through automation while maintaining diagnostic precision. The company completed FDA pre-submission requirements in March 2025.
Commitment to GI Innovation
“This European launch and our U.S. trial progress demonstrate our dedication to advancing GI diagnostics,” said ALPCO CEO Erik Allen. The developments highlight the company’s strategy to provide both accessible immunoturbidimetric testing and next-generation automated solutions for laboratories worldwide.
Corporate Growth Trajectory
The diagnostic milestones follow ALPCO’s 2022 merger with GeneProof and subsequent rebranding under parent company NuvinkaDx in 2024. This expansion strengthens ALPCO’s position as a global provider of specialty immunodiagnostic and molecular testing solutions for clinical laboratories.
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