ALPCO Launches Innovative Calprotectin Assay and Begins Clinical Trials in the US

ALPCO Announces European Launch of Calprotectin Assay

American Laboratory Products Company (ALPCO) has recently made significant strides in the field of gastrointestinal diagnostics with the European launch of its Calprotectin Immunoturbidimetric Assay. This innovative test is set to enhance the diagnosis and management of inflammatory bowel diseases (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC). It aims to aid healthcare professionals in distinguishing IBD from irritable bowel syndrome (IBS) based on laboratory findings.

The Calprotectin assay has received FDA 510(k) clearance in 2023, coupled with IVDD certification since 2022, marking a significant leap towards supporting in vitro diagnostic applications. It boasts impressive clinical performance metrics with a sensitivity of 90.5% and specificity of 93.4%. Such high accuracy means that healthcare providers can prioritize patients more effectively for colonoscopy procedures, leading to expedited and precise diagnosis and treatment pathways. With a low false positive rate, this test enhances the overall efficiency of the diagnostic process in clinical settings.

In tandem with this launch, ALPCO is also making strides in the United States, having successfully enrolled its first patient in a pivotal clinical trial aimed at securing FDA clearance for an automated chemiluminescent version of the Calprotectin assay. This upgraded assay is designed to function on the KleeYa™ system and represents a substantial advancement in laboratory automation. The pre-submission process with the FDA was concluded in March 2025, and patient enrollment for the trials began shortly thereafter in April.

“We’re excited to deliver a high-throughput GI test compatible with existing clinical chemistry analyzers, which continues to differentiate accurately between IBD and IBS,” commented Erik Allen, CEO of ALPCO, which is part of the NuvinkaDx family. He also mentioned that the launch reflects the company’s dedication to enhancing GI diagnostic solutions with greater automation and precision.

The dual achievement of launching the assay in Europe while commencing the clinical trial in the US underscores ALPCO’s commitment to innovation and leadership within the gastroenterology diagnostic landscape. As ALPCO continues to evolve since its inception in 1991, the company now stands as a prominent provider of specialized diagnostic solutions tailored for various laboratory needs across the globe. This evolution has been particularly bolstered by ALPCO’s merger with GeneProof in 2022, a Czech company noted for its advanced molecular diagnostics.

The Calprotectin Immunoturbidimetric Assay is not only a testament to ALPCO's commitment to enhancing patient care through better diagnostic tools but also signifies a larger step in the ongoing race towards more automated and efficient healthcare solutions. As the market for gastrointestinal diagnostics continues to expand, ALPCO’s focus on innovation through research and development will likely play a pivotal role in shaping the future of diagnostics in both Europe and the United States.

For further details on ALPCO's offerings and future developments, please visit www.alpco.com and www.geneproof.com.