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Bühlmann Labs IBD Assay FDA Cleared

NEW YORK — Swiss diagnostics firm Bühlmann Laboratories said on Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its fCal Turbo calprotectin test.

The in vitro diagnostic uses turbidimetry to measure levels of fecal calprotectin (fCal), a neutrophilic protein biomarker of intestinal mucosal inflammation, in human stool to aid in the diagnosis of inflammatory bowel disease, specifically Crohn's disease and ulcerative colitis. It also can be used to differentiate IBD from irritable bowel syndrome when used in conjunction with laboratory and clinical findings.

Bühlmann CEO Doug Olson said in a statement that the fCAL turbo assay represents a high-throughput option to the company's recently FDA-cleared fCal ELISA assay.