Gentian Diagnostics ASA

Regulatory Filings • Jun 22, 2018

GENTIAN ACHIEVES PROOF OF CONCEPT ON FECAL PANCREATIC ELASTASE

GENTIAN ACHIEVES PROOF OF CONCEPT ON FECAL PANCREATIC ELASTASE

GENTIAN DIAGNOSTICS AS HAS OBTAINED PROOF OF CONCEPT FOR A NEW PRODUCT FOR EXOCRINE PANCREATIC INSUFICIENCY AND MONITORING OF PANCREATIC FUNCTION

Moss, 22.06.2018

Gentian Diagnostics (OSE: GENT-ME) is pleased to announce that it has achieved proof of concept on turbidimetric measurement of Fecal Pancreatic Elastase (fPELA). The project was initiated in November 2017 in collaboration with Gentian's established partner BÜHLMANN Laboratories AG in Basel.

The test to be developed from this concept is a measure of Pancreatic Exocrine Insufficiency (PEI) associated with various health conditions, e.g. chronic pancreatitis, cystic fibrosis, celiac disease, diabetes, post-pancreatic surgery, gastrectomy etc.

fPELA testing today is only commercially available on ELISA platforms, and testing is likely to increase if available on highly automated, high throughput chemistry analyzers. If successful, Gentian and its partner BÜHLMANN estimates that the annual test volume could reach 5 to 10 Mio tests annually ex USA.

Commenting on the news, CEO Thomas Hafen in Bühlmann Laboratories AG says: "Accompanied by Gentian BÜHLMANN already has commercialized fCAL©turbo, and we are experiencing strong growth. The combination of fCAL©turbo and an fPELA turbo test will significantly strengthen our market position, even more as fCAL and fPELA will be measured from the very same stool extract in CALEX© Cap. (BÜHLMANN' s proprietary fecal sample tube)"

CEO in Gentian, Bård Sundrehagen adds: "Based on the highly successful cooperation between Gentian and BÜHLMANN over the past 6 years, we have now signed an exclusive cooperation agreement comprising development of fPELA and worldwide distribution on the same platforms as for fCAL© turbo."

For further information, please contact:

Bård Sundrehagen

CEO, Gentian Diagnostics AS

E-mail: bard.sundrehagen@gentian.no

Cell Phone: +47 924 14 117

Njaal Kind

CFO, Gentian Diagnostics AS

E-mail: njaal.kind@gentian.no

Cell Phone: +47 919 06 525