OSLO: Gentian Diagnostics ASA, a fast-growing developer and manufacturer of innovative diagnostic solutions for improved clinical decision making, has entered into a distribution agreement for its Cystatin C Immunoassay. The agreement is with one of the world’s largest global diagnostics companies and covers the United States, a key growth market for Cystatin C.
Gentian’s commercial strategy is to secure broad roll-out and acceptance of its products, which requires distribution through the global diagnostics companies. The distribution agreement for Cystatin C further validates Gentian’s ability to establish such commercial partnerships with global industry leaders and follows previously announced agreements with other global diagnostics companies.
Cystatin C supports early detection of reduced kidney function, which contributes to preventing severe kidney failure. The immunoassay can be adapted to all major clinical chemistry analysers.
“This agreement is an important milestone for Gentian, as it makes our Cystatin C assay readily available to a larger patient population. Together, Gentian and our new partner will facilitate the adoption of the recommendations issued by the American Society of Nephrology and the National Kidney Foundation,” says Gentian Diagnostics CEO Hilja Ibert.
Revenue from the Gentian Cystatin C immunoassay increased by 41% in 2021 vs 2020. The immunoassay is one of four established products, which combined is expected to contribute with 20%+ annual revenue growth over the coming 4 to 6 years. By comparison, Gentian delivered 27% revenue growth in 2018-2021 and reached the milestone of NOK 100 million in total revenue in 2021.
The Gentian Cystatin C Immunoassay (CE marked and FDA-510(k) cleared) is an in-vitro diagnostic (IVD) test for quantitative determination of Cystatin C in human serum and plasma. Cystatin C has been recognised both as a complimentary and as an alternative biomarker to creatinine in calculating estimated glomerular filtration rate (eGFR), a key metric in the clinical assessment of kidney function.
The increasing demand for Cystatin C comes predominantly from Europe and the US, where Gentian has established market positions. Going forward, Gentian will continue to focus its efforts on European and American distribution channels to further expand the market for Cystatin C and increase Gentian’s market share.