ALPCO Announces the Commercial Launch of its FDA 510(k) Cleared Calprotectin Immunoturbidimetric Assay

NEWS RELEASE

ALPCO Announces the Commercial Launch of its FDA 510(k) Cleared Calprotectin Immunoturbidimetric Assay

SALEM, NH, December 19, 2023 – American Laboratory Products Company, Ltd. ("ALPCO"), a global provider of specialty diagnostic solutions, proudly announces the commercial launch of its FDA 510(k) cleared Calprotectin Immunoturbidimetric Assay, enhancing its suite of Gastrointestinal (GI) diagnostic solutions.

In July 2023, ALPCO unveiled the Calprotectin Immunoturbidimetric Assay at the American Association for Clinical Chemistry (now ADLM) annual meeting. This assay, cleared for in vitro diagnostic use, aids in diagnosing inflammatory bowel disease (IBD) - specifically Crohn’s disease (CD) and ulcerative colitis (UC), while also assisting in differentiating IBD from irritable bowel syndrome (IBS) when used alongside other clinical and laboratory findings.

This innovative assay showcases a clinical sensitivity of 90.5% and a clinical specificity of 93.4%. Its low false-positive rate enables clinicians to effectively prioritize patients for confirmational colonoscopies, thereby minimizing unnecessary procedures for IBS patients.

A Pivotal Addition to ALPCO’s GI Solutions Suite

The Calprotectin IT Assay is a strategic addition to ALPCO's comprehensive GI solutions menu, offering an appealing option particularly for hospitals and large reference labs seeking reliable, efficient, and high throughput testing solutions. ALPCO has always been dedicated to blending the benefits of automation with expertise in immunoassays, a commitment that is exemplified in the Calprotectin Immunoturbidimetric Assay.

Erik Allen, CEO of ALPCO-GeneProof, expressed, "We're thrilled to deliver a high-throughput test that is compatible with existing clinical chemistry analyzers while preserving accurate differentiation between IBD and IBS, embodying our unwavering commitment to providing efficiency, reliability, and accuracy for our customers."

A Resounding Early Adoption

The early adoption of the new calprotectin assay has been met with overwhelming success. Dr. Amy Peace Brewer, Chief Scientific Officer and Senior Laboratory Director at Genova Diagnostics, remarks on the assay's performance, "[ALPCO’s] new calprotectin assay is very impressive. We were able to validate and get the assay into production in a very short time frame. The assay hasn’t let us down and performs in a robust and reliable way. The very quick run times accommodate large batches with ease and efficiency."



About ALPCO-GeneProof

ALPCO was founded in 1991 as an importer and distributor of immunoassay-based products for the North American life science markets. The company has since evolved into a leading producer of novel immunodiagnostic reagents for specialty testing laboratories. In 2022, ALPCO merged with GeneProof, a Czech Republic-based provider of specialty molecular diagnostic solutions. Founded in 2005, GeneProof offers a portfolio of more than 80 products many of which are IVDR-certified for infectious diseases and genetic mutations, as well as a suite of proprietary instrumentation for clinical laboratories of all sizes. For additional information, please visit www.alpco.com and www.geneproof.com.