Moss, 31 January 2022
Reference to the stock exchange release dated 5 October 2021 and the 3rd quarter report released on 21 October 2021, Gentian Diagnostics ASA, a fast-growing developer and manufacturer of innovative and efficient diagnostics for better treatment decisions, has entered a global distribution contract for the Gentian Calprotectin Immunoassay GCAL® with Siemens Healthineers. The GCAL® assay will be offered on the Siemens Healthineers BN™ II, BN ProSpec®, and Atellica® NEPH platforms and positioned toward the rheumatoid arthritis market, with launch scheduled for the first half of 2022. Siemens Healthineers is a market leader in nephelometric plasma protein testing.
The GCAL® assay is available for quantitative measurement of calprotectin in plasma and serum, which is an early biomarker for detection and assessment of the inflammatory response to severe infections and other inflammatory conditions like rheumatoid arthritis. The Siemens Healthineers BN II platform is a fully automated system with a large installed base, and additional systems from Siemens Healthineers are scheduled to be added at a later stage.
“This is an important milestone for Gentian, as this makes our innovative GCAL® assay readily available for a larger patient group. Siemens Healthineers is one of the global leaders in clinical diagnostics, with its large installed base of laboratory testing systems and assays,” says Gentian Diagnostics CEO Hilja Ibert.
The GCAL® assay will initially be made available in Europe, with expansion to additional countries or regions depending on regulatory clearance.
Rheumatoid arthritis is a chronic inflammatory autoimmune disease affecting more than 1% of the adult world population, and early detection is critical to ensure prevention of disabling joint erosion. Industry analysts estimate the value of the rheumatoid arthritis diagnosis test market at more than USD 550 million in 2020, with growth potential to more than USD 750 million by 2027, and the serviceable market for GCAL in this segment is estimated at USD 30–60 million.
Earlier in 2021, Gentian outlined the roadmap for its portfolio of high-impact diagnostic tests, which supports the company’s revenue growth ambitions. The company expects GCAL® to be one of the main value drivers in the realization of this growth roadmap, and confirming clinical relevance and entering global commercial partnerships are key enablers.
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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 Securities Trading Act. This stock exchange announcement was published by Njaal Kind, CFO at Gentian Diagnostics ASA, on 31 January 2022 at 14:00 CET.