Summary:

ALPCO has launched its FDA-cleared Calprotectin Immunoturbidimetric Assay in Europe and begun a pivotal U.S. clinical trial for a more automated version, reinforcing its leadership in gastrointestinal diagnostics.

Takeaways:

  1. Global Expansion: The assay’s European launch strengthens ALPCO’s global footprint in GI diagnostic solutions.
  2. Diagnostic Accuracy: With over 90% sensitivity and specificity, the assay aids in distinguishing IBD from IBS.
  3. Automation Advancement: A U.S. clinical trial is underway for a chemiluminescent version aimed at improving lab efficiency.

American Laboratory Products Company, Ltd., a global provider of specialty diagnostic solutions, announced the European commercial launch of its Calprotectin Immunoturbidimetric Assay, expanding its portfolio of gastrointestinal (GI) diagnostic solutions globally. 

Calprotectin Immunoturbidimetric Assay is FDA 510(k) Cleared

The Calprotectin Immunoturbidimetric Assay, which received FDA 510(k) clearance in 2023 and IVDD certification in 2022, is intended for in vitro diagnostic use to aid in the diagnosis of inflammatory bowel disease (IBD)—including Crohn’s disease (CD) and ulcerative colitis (UC)—and to help differentiate IBD from irritable bowel syndrome (IBS) when used alongside other clinical and laboratory findings. 

With a clinical sensitivity of 90.5% and specificity of 93.4%, the test offers high diagnostic accuracy and a low false positive rate. This enables healthcare providers to efficiently prioritize patients for colonoscopy, supporting faster diagnoses and more targeted care decisions. 

U.S. Clinical Trial for Assay Use

In addition to expanding its offerings to the European market, ALPCO confirmed the first patient enrolled in its pivotal clinical trial for US FDA clearance of an automated chemiluminescent version of ALPCO’s leading calprotectin assay, designed for use on the KleeYa system. ALPCO completed the FDA pre-submission process in March 2025, with clinical trial enrollment beginning in April. The company’s calprotectin assays have been integral to ALPCO’s success in the GI market and the chemiluminescent platform represents a significant advancement in automation, aiming to provide clinical laboratories with a streamlined, efficient, and scalable solution for calprotectin testing. 

“We’re thrilled to deliver a high-throughput GI test that is compatible with existing clinical chemistry analyzers while preserving accurate differentiation between IBD and IBS,” says Erik Allen, CEO of ALPCO (A NuvinkaDx company). “In parallel, we’re advancing our mission to deliver GI diagnostic solutions with greater automation and accuracy to clinical labs in the US.” 

This dual milestone—the European launch of the Calprotectin Immunoturbidimetric Assay and the start of the pivotal US trial—underscores ALPCO’s commitment to innovation and leadership in GI diagnostics. 

Featured Image: Dizain777 | Dreamstime.com