Skip to main content
Premium Trial:

Request an Annual Quote

Bühlmann Labs Gets FDA Clearance for Calprotectin Inflammatory IBD Assay

NEW YORK (360Dx) – Bühlmann Laboratories said Thursday that it has received US Food and Drug Administration clearance for its fCal ELISA assay, which uses the measurement of calprotectin protein in human stool to diagnose inflammatory bowel disease, more specifically Crohn’s disease and ulcerative colitis. The assay can also be used in conjunction with other laboratory and clinical findings to differentiate IBD from irritable bowel syndrome, the firm said.

Due to the high prevalence of gastrointestinal disease and challenges of current treatment pathways, the use of a noninvasive inflammation biomarker such as calprotectin is essential in helping physicians evaluate patients in a timely manner, according to Bühlmann.

KT Park, codirector of Stanford Children's IBD Center at Stanford University School of Medicine, said in a statement that screening fecal calprotectin prior to diagnostic endoscopy is a cost-effective approach to differentiate IBD from IBS. He said that "expanding the marketplace of calprotectin with high-quality assay options should enhance patient care."

Buhlmann Laboratories is based in Switzerland and offers products in the in vitro diagnostics and research markets. Its North American affiliate, Buhlmann Diagnostics, headquartered in Amherst, New Hampshire, provides ELISA kits, radioimmunoassay kits, lateral flow kits, and flow cytometry kits.