American Laboratory Products Company (ALPCO) has announced the European commercial launch of its Calprotectin immunoturbidimetric assay.
The launch follows the US Food and Drug Administration (FDA) IVDD certification granted in 2022 and 510(k) approval of the Calprotectin assay in 2023.
The Calprotectin Immunoturbidimetric Assay aids in diagnosing inflammatory bowel disease (IBD) and differentiating it from irritable bowel syndrome (IBS).
The assay, designed for use on the KleeYa system, offers a clinical sensitivity of 90.5% and specificity of 93.4%, which helps healthcare providers prioritise patients for colonoscopy.
Its high diagnostic accuracy facilitates quicker diagnoses and more targeted care decisions.
In addition to its European launch, ALPCO has enrolled the first patient in a pivotal US clinical trial for an automated chemiluminescent version of its calprotectin assay.
The FDA pre-submission process was completed in March 2025, with clinical trial enrolment starting in April.
ALPCO CEO Erik Allen said: “We’re thrilled to deliver a high-throughput GI test that is compatible with existing clinical chemistry analysers while preserving accurate differentiation between IBD and IBS.
“In parallel, we’re advancing our mission to deliver GI diagnostic solutions with greater automation and accuracy to clinical labs in the US.”
Founded in 1991, ALPCO initially focused on importing and distributing immunoassay-based products in North America and has become a producer of novel immunodiagnostic reagents.
In 2022, ALPCO merged with GeneProof from the Czech Republic, a provider of molecular diagnostic solutions, and was rebranded to NuvinkaDx last year.
The expansion marks a significant step in ALPCO’s global strategy to enhance its gastrointestinal diagnostic solutions.
Calprotectin assays have been crucial to its success in the gastrointestinal market.
The chemiluminescent platform represents a significant advancement in automation and aims to provide a streamlined and scalable solution for calprotectin testing.
