Gentian is a Norwegian IVD company that specialises in developing and manufacturing turbidimetric assays that enable clinical lab professionals to achieve greater operational efficiency, thus providing faster patient results to clinicians. The current portfolio and pipeline of diagnostic reagents span areas of kidney disease, cardiac disease, inflammation, infection and veterinary medicine.
By leveraging both our expertise in Particle-Enhanced Turbidimetric Immunoassays (PETIA) and proprietary nanoparticle technology, we develop immunoassays that enable users to transition from traditional low volume immunology platforms to fully automated clinical chemistry instruments. The typical Gentian customer enjoys shorter turnaround times, streamlined workflows and improved cost efficiency.
Through customer-centric assay development, we aim to launch products available for all major clinical chemistry platforms currently on the market. This means that Gentian’s turbidimetric immunoassays can be added to your laboratory test menu without additional investment in instrumentation. Any configurations (kitting, bulk supply, packaging and private label) of our products already introduced to the market or in development are available.
We manufacture reagents for both laboratories and industry partners. R&D, production, marketing and distribution are performed at our headquarters in Norway. Global operations are supported by subsidiaries in Sweden and the US, and through a representative office in China.
Gentian collaborates with companies, agencies and end-users in all stages of research, development, manufacturing and distribution of immunoassays. By collaborating with Gentian, our partners are offered the opportunity to expand their test menus without additional investments in R&D infrastructure. Research, development and manufacturing operations are performed in-house at the Gentian HQ in Norway.
10 minutes to result
Quality & Accuracy
We are continuously evaluating and improving our operations to increase the satisfaction of our customers, employees, owners and the markets we operate in. We make sure that every new product we develop meets the highest performance standards.
Gentian integrates its Quality Management System and Design Control Standards within all areas of the company, including Research, Development and Production.
Gentian has implemented the new EU regulatory requirements in our systems and processes to ensure continuous compliance and made all necessary preparations to be prepared for IVDR and future certifications.
Gentian’s GCAL® and Cystatin C assays are the two first products certified by TüV SÜD as complying with the European In-Vitro Diagnostic Regulation (IVDR), EU 2017/746.
At Gentian we are a diverse team, with more than 15 national backgrounds represented. Our employees are highly specialised with technical and personal skills essential for our success. We thrive on working together with the focus to maintain fruitful environments where new ideas and opportunities are explored. Customer focus is a special strength of the company as it is solidly rooted in all departments, keeping a consistent eye on customer needs and service. We are always eager to support and strengthen all internal and external relationships, essential components when planning for a bright future ahead!
Gentian was started by brothers Erling and Bård Sundrehagen in 2001. Having originally worked together during the founding of Axis (later Axis-Shield ltd, Alere inc. and now Abbott), they were eager to start a new, innovative venture together in the diagnostics field. From a small office in central Moss, 50 km south of Oslo, Norway, speaking to laboratory doctors across Scandinavia, they quickly identified a gap in the IVD market for a high quality, sensitive, turbidimetric cystatin C immunoassay.
The Gentian Cystatin C Immunoassay was launched in 2006 and after fast uptake in Sweden, an FDA 510(k) clearance was achieved in 2008. The Beijing representative office was opened in 2010 and Gentian USA Inc. established 2012 to expand the global reach of Gentian. In 2016, the Swedish subsidiary Gentian Diagnostics AB was established to take charge of product distribution in Sweden and the Nordics.
The company soon outgrew their original facilities and opened up a dedicated laboratory and office space in 2011 in Moss. The team expanded and development began on multiple new products, and in August 2022 the company's new and expanded facilities were officially opened by the Norwegian Health minister.