Gentian Diagnostics ASA

Regulatory Filings • Aug 13, 2019

GENTIAN BECOMES SOLE REAGENT SUPPLIER IN SALES CHANNEL AGREEMENT BETWEEN ROCHE AND BÜHLMANN FOR fCAL® turbo

Moss, 13.08.2019

Gentian Diagnostics is pleased to announce an agreement as sole reagent supplier in a sales channel agreement between Roche Diagnostics, the in vitro diagnostics (IVD) market leader, and Gentian's sales, marketing and development partner BÜHLMANN Laboratories AG. Gentian will deliver the BÜHLMANN fCAL® turbo immunoassay reagents for the Roche/BÜHLMANN co-branded test-kit, supplied with a large install-base of clinical chemistry instruments, the COBAS® c501/502 series. With this agreement the innovative product for high volume fecal testing and monitoring of Inflammatory Bowel Disease (IBD) will be available to Roche´s laboratory customers globally.

The market for fecal testing is today mainly served by semi-automatic tests with less effective workflow and unfavourable handling properties compared to the innovative BÜHLMANN fCAL® turbo. The test is mainly used in Europe, but is in early stage development in the US and other markets globally. Gentian estimates that the total market for fecal calprotectin testing was approximately NOK 150 million¹ , with an estimated underlying growth of 10-15%.

First deliveries to the Roche channel is expected from the third quarter 2019, but volume impact from the agreement will affect Gentian´s revenue as of 2020.

Gentian has in cooperation with its partner BÜHLMANN delivered the BÜHLMANN fCAL® turbo to the market since 2016 and recorded an 81% sales growth in 2018 with sales reaching NOK 9.9 million. The BÜHLMANN fCAL® turbo is the most automated IVD test system for IBD on the market. It enables laboratories to provide results faster to their clinicians and to run higher test volumes, based on the increasing demand for IBD laboratory diagnostic solutions.

Gentian´s CEO Dr. Hilja Ibert says: "With Roche we will have a world class IVD commercial organization promoting the BÜHLMANN fCAL® turbo. This will significantly increase the awareness of our innovative product. Together, we aim to improve the management of inflammatory bowel disease."

¹Market size expressed as Gentian's addressable market. End-user market would be significantly higher.

For further information please contact: Hilja Ibert CEO, Gentian Diagnostics AS E-mail: hilja.ibert@gentian.com +47 919 05 242

Njaal Kind CFO, Gentian Diagnostics AS E-mail: njaal.kind@gentian.com +47 919 06 525

About Roche

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. For more information, please visit www.roche.com.

About BÜHLMANN Laboratories AG

Founded in 1976, BÜHLMANN Laboratories AG has continued to focus on growing a product portfolio of in vitro diagnostics markets worldwide. BÜHLMANN is known for outstanding product quality, providing excellent after-sales services, and delivering remarkable scientific innovations. BÜHLMANN offers the broadest range of calprotectin products as well as a selection of unique, high-quality assays such as the BÜHLMANN Flow CAST® product group for Basophil Activation Testing the BÜHLMANN GanglioCombi™ products for neuroimmunology, or a variety of quantitative, rapid tests on Quantum Blue® including calprotectin or TDM assays. For more information, please visit www.buhlmannlabs.ch

About Gentian

Gentian designs, develops and markets in vitro diagnostic reagents (IVD) based on its proprietary Nanosense technology. The goal is to offer efficient and accurate reagents for major clinical chemistry platforms with a focus within the areas of kidney disease, cardiac disease, inflammation and veterinary medicine. The Nanosense technology will enable users to move assays from low volume immunology platforms to fully automated, high throughput instruments with shorter turnaround times, better workflow and improved cost efficiency.

Gentian is headquartered in Moss, Norway. For more information, please visit www.gentian.com