Gentian Diagnostics AS is pleased to announce that BÜHLMANN has received 510(k) clearance (K190784) from the FDA for the BÜHLMANN fCAL® turbo. BÜHLMANN is Gentian’s exclusive commercial partner for the fecal calprotectin products worldwide.
The potential US fecal calprotectin market is of an estimated size of USD ~30 million, while the current market is of an estimated size of USD ~5 million. Hilja Ibert, CEO Gentian Diagnostics AS comments “While the fecal calprotectin market size in the US is still quite small, fecal calprotectin is part of a high annual growth market, as observed in Europe. The already FDA cleared BÜHLMANN fCAL® ELISA has paved the way for BÜHLMANN fCAL® turbo which will allow for high throughput analysis of fecal calprotectin in applicable core laboratories and screening programmes.”