Gentian Diagnostics ASA

Regulatory Filings • Jun 28, 2019

fCAL® turbo RECEIVES 510(K) CLEARANCE IN THE USA

fCAL® turbo RECEIVES 510(K) CLEARANCE IN THE USA

Moss, 28.06.2019

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.”

For further information, please contact:

Hilja Ibert

CEO, Gentian Diagnostics AS

E-mail: hilja.ibert@gentian.no

Cell Phone: +47 919 05 242

Njaal Kind

CFO, Gentian Diagnostics AS

E-mail: njaal.kind@gentian.no

Cell Phone: +47 919 06 525