Gentian Diagnostics ASA

Regulatory Filings • Oct 27, 2022

Gentian Diagnostics signs distribution agreement with a major diagnostic company for the GCAL® Calprotectin Immunoassay

Gentian Diagnostics signs distribution agreement with a major diagnostic company for the GCAL® Calprotectin Immunoassay

Moss, 27 October 2022

Gentian Diagnostics ASA, a fast-growing developer and manufacturer of innovative diagnostic solutions for improved clinical decision making, has entered into a global distribution agreement for its GCAL® Calprotectin Immunoassay with a major diagnostic company.

“This is the second distribution agreement for GCAL® announced this year, which confirms the products’ value proposition and market potential. The agreement is a result of our market development efforts, and the fact that we’re gaining commercial traction with several of the world’s leading diagnostics companies supports our long-term growth ambition,” says Gentian Diagnostics CEO Hilja Ibert.

The cooperation is positioned towards the market for detection and assessment of inflammatory diseases and infections, with launch scheduled for the first half of 2023, initially in Europe. Depending on regulatory clearance this product will be available in additional countries and regions at a later stage.

Gentian’s commercial strategy is to secure broad roll-out and acceptance of its products, which requires distribution and awareness through leading global diagnostics companies.

The Gentian GCAL® Calprotectin Immunoassay is available in the market for quantitative measurements of calprotectin in plasma and serum samples and based on published scientific findings it is expected to become a key clinical value driver.

According to the stock exchange release dated 28 September 2022, Gentian obtained the European In-Vitro Diagnostic Regulation (IVDR) certification for its first products and the Gentian GCAL® Calprotectin Immunoassay is among these certified products.

For further information, please contact:

Hilja Ibert, CEO

hilja.ibert@gentian.no

+47 919 05 242

Njaal Kind, CFO and COO

njaal.kind@gentian.no

+47 919 06 525

About Gentian Diagnostics

Gentian Diagnostics (OSE: GENT), founded in 2001, develops and manufactures high-quality, in vitro diagnostic reagents. Gentian’s expertise and focus lies within immunochemistry, specifically infections, inflammations, kidney failures and congestive heart failures. By converting existing and clinically relevant biomarkers to the most efficient automated, high-throughput analysers, the company contributes to saving costs and protect life. Gentian is based in Moss, Norway, serving the global and veterinary diagnostics markets through sales and representative offices in Sweden, USA and China. For more information, please visit www.gentian.com.

This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Security Trading Act. This stock exchange announcement was published by Njaal Kind, CFO & COO at Gentian Diagnostics ASA, on 27 October 2022 at 09:20 CET.