BÜHLMANN Laboratories AG Receives FDA Clearance for its fCAL® turbo Automated Calprotectin Test

BÜHLMANN fCAL® turbo, an in vitro diagnostic assay intended for the quantitation of calprotectin in human stool, has received 510(k) clearance from the Food and Drug Administration (FDA) and is now commercially available in the US.

Amherst NH, June 26, 2019: BÜHLMANN Laboratories AG, is proud to announce it received United States Food and Drug Administration (FDA) 510(k) clearance of its BÜHLMANN fCAL® turbo. This turbidimetric test was successfully launched all over the world and is now available on the U.S. market. The BÜHLMANN fCAL® turbo is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin (fCAL), a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The BÜHLMANN fCAL® turbo aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.  Utilizing calprotectin for diagnostic testing demands the test be accurate and reproducible over long periods of time which is one of the key characteristics of BÜHLMANN fCAL® turbo.

The use of a non-invasive inflammation bio-marker such as calprotectin is crucial with the increasing prevalence of gastrointestinal disease and the challenges of traditional treatment pathways. The 2018 clinical guidelines of the American College of Gastroenterology (ACG) strongly recommends fCAL as helpful test that should be considered as an aid to differentiate the presence of IBD from IBS. As a result, major health insurance companies have started covering calprotectin testing (CPT: 83993).

Due to the quality performance and high capacity of BÜHLMANN fCAL® turbo, this assay can be applied economically in low/mid volume laboratories as well as in very high volume reference labs. Testing turnaround time can be reduced significantly not only compared to the existing ELISA methods but also to other automated, random access calprotectin assays. BÜHLMANN fCAL® turbo is a real milestone for efficient handling of increasing workloads in the laboratory being the highest throughput calprotectin assay with the fastest time-to-first-result in the U.S. market.

Doug Olson, CEO of BUHLMANN Diagnostics Corp commented, “We are very pleased to launch this robust, high quality assay to assist physicians in evaluating patients in a timely manner and to help laboratories across North America to meet the increasing demand for calprotectin testing. This test provides a high throughput option to our FDA cleared BÜHLMANN fCAL® ELISA, providing flexibility in testing options.  Most importantly, this assay portfolio offers consistency- no matter which assay you choose, results are reliable, accurate, and consistent across the platforms.”

In a multi-site clinical study, BÜHLMANN fCAL® turbo demonstrated excellent precision and reproducibility, while confirming that this test is a valuable diagnostic aid in the diagnosis of IBD and in the discrimination between IBD and IBS.

Visit www.buhlmannlabs.com to learn more about this assay, and overall performance.

About BÜHLMANN Laboratories AG

Founded in 1976, BÜHLMANN Laboratories AG has continued to focus on growing a product portfolio of in vitro diagnostics and research markets. BÜHLMANN is known for outstanding product quality, providing excellent after-sales services, and delivering remarkable scientific innovations. BÜHLMANN offers the broadest range of calprotectin products as well as a selection of unique, high-quality assays such as the BÜHLMANN Flow CAST® product group for Basophil Activation Testing, the BÜHLMANN GanglioCombi™ products for neuroimmunology, and a variety of Melatonin Assays.

About BUHLMANN Diagnostics Corp (BDC)

BUHLMANN Diagnostics Corp (BDC) is the North American affiliate of BÜHLMANN Laboratories AG, the worldwide provider of ELISA kits, RIA kits, lateral flow and flow cytometry assays. Located in Southern New Hampshire, BDC has a highly experienced team who represent a breadth of experience in serving both clinical and basic science research laboratories.

About BÜHLMANN Calprotectin Product Line

The calprotectin portfolio consists of the BÜHLMANN fCAL® ELISA (FDA 510(k) cleared), BÜHLMANN fCAL® turbo (FDA 510(k) cleared)for testing on most clinical chemistry analyzers, Quantum Blue® fCAL Rapid Test (RUO in the US), and IBDoc®, the first and only Health Canada Licensed home-testing application for fecal calprotectin in IBD patients (IBDoc® not available for sale in the US).