Operational summary
Sales
In the third quarter of 2026, Gentian once again delivered record quarterly sales of NOK 51.1 million, an increase of 22% from NOK 41.8 million in Q3 2025, corresponding to 30% currency-neutral organic growth. Sales for the first nine months of 2026 reached NOK 144.8 million, up 11% from the same period last year, equivalent to 17% currency-neutral organic growth.
Cystatin C
Cystatin C sales in Q3 2026 were NOK 18.5 million, compared with NOK 15.5 million in Q3 2025, representing growth of 19%. For the first nine months of 2026, sales totalled NOK 50.2 million, compared with NOK 50.6 million in the corresponding period of 2025.
The record-high quarterly sales were primarily driven by increasing demand from our largest partner in the United States, where awareness and adoption of Cystatin C testing continue to grow. Sales in China increased by 6% compared with Q3 2025, while other channels remained broadly in line with the prior-year quarter. Based on strong order intake for Q4, we expect Cystatin C to deliver year-over-year growth for the full year 2026.
fCAL turbo
fCAL turbo sales increased by 23% in Q3 2026 to NOK 19.5 million, compared with NOK 15.9 million in Q3 2025. Year-to-date sales reached NOK 53.1 million, up 22% from NOK 43.5 million in the same period last year.
Growth was driven by successful acquisition of new accounts and increasing testing volumes across all regions. In addition, global partners continued to deliver according to expectations. fCAL turbo is exclusively commercialised by our partner BÜHLMANN Laboratories.
Other Products
The Other Products category, consisting of fPELA turbo, GCAL, cCRP and milestone payments related to product developments, delivered mixed performance across the portfolio. Sales increased by NOK 0.2 million in Q3 2026 compared with Q3 2025. Cumulative sales for the first nine months of 2026 amounted to NOK 24.8 million, compared with NOK 21.0 million in the corresponding period of 2025, representing growth of 18%.
A notable development was the continued uptake of fPELA testing among existing fCAL customers, reflecting the benefits of measuring both biomarkers from the same patient sample and collection device.
Third Party Products
Sales in Gentian Diagnostics AB (GAB), the Company's Swedish distribution subsidiary reported under Third Party Products, increased by 72% to NOK 5.8 million in Q3 2026, compared with NOK 3.4 million in Q3 2025. Year-to-date sales amounted to NOK 16.6 million, compared with NOK 14.9 million in the same period last year, representing growth of 12% and reflecting continued solid demand in the Nordic market.
Regional Performance
The United States delivered solid regional performance in Q3 2026, with sales increasing 23% compared with Q3 2025. Year-to-date sales reached NOK 32.3 million, up 49% from NOK 21.7 million in the corresponding period last year. Demand for Cystatin C continued to increase, supported by broader clinical adoption, updated guidelines, and a growing body of scientific evidence. Growth was driven by both partner-led sales and direct customer activities.
Sales in Europe reached NOK 33.3 million in Q3 2026, representing good growth of 24% compared with Q3 2025. For the first nine months of 2026, sales totalled NOK 96.4 million, an increase of 15% from the same period last year. Growth was primarily driven by continued strong performance of products commercialised through our partner BÜHLMANN Laboratories.
Sales in Asia increased by 6% in Q3 2026 to NOK 4.5 million compared with Q3 2025. For the first nine months of 2026, sales amounted to NOK 16.1 million, a decrease of 33% compared with the corresponding period of 2025. The decline continued to be driven by China, where government-imposed pricing and testing restrictions have impacted market demand. Continued growth in South Korea partially offset the lower sales recorded in China.
Market development GCAL®
Gentian continues to expand the clinical positioning of GCAL across inflammatory, cardiovascular and infectious diseases, supporting earlier diagnosis, disease monitoring and treatment decisions. Commercial activities remain focused on increasing the adoption of serum/plasma calprotectin testing in inflammatory rheumatic diseases, in line with the strategic priorities of Gentian's commercial partners.
Strengthening the clinical evidence base in paediatric rheumatology
New data presented at the European Paediatric Rheumatology Society (PReS) Congress in September further supported the clinical utility of serum calprotectin in juvenile idiopathic arthritis (JIA).
Results from Gentian's prospective international JIA-COMPASS study included 323 patient visits from 128 patients with non-systemic JIA and demonstrated that GCAL levels closely tracked disease activity. Consistent with expectations, GCAL concentrations were lower in patients in remission than in those with active disease and showed correlation with established clinical measures of disease activity. Patient follow-up is ongoing to further evaluate the potential of GCAL for monitoring treatment response and predicting disease flare.
In addition, independent studies presented at PReS reported similar findings, providing further evidence that serum calprotectin reflects disease activity and may offer clinically relevant information beyond conventional inflammatory markers. Collectively, these data reinforce the growing body of evidence supporting the use of GCAL in disease monitoring and treatment decision-making in paediatric rheumatology.
Pipeline development
R&D strategy execution
During Q3, Gentian continued to execute the updated R&D strategy introduced in the previous quarter, with increased focus on portfolio diversification, accelerated development and disciplined prioritisation through strengthened pipeline governance process. The updated strategy is delivering a broader and more diversified development pipeline, with eight projects progressing in parallel through both strategic partnerships and internally initiated development activities.
Accelerated product development and a broader pipeline. Gentian is pursuing multiple PETIA development opportunities, combining projects initiated together with established and new IVD partners with internally identified opportunities addressing attractive clinical and market needs. This broader approach allows Gentian to leverage its existing technology platform and development capabilities while balancing development risk, commercial potential and time-to-market. In parallel, Gentian continues to explore opportunities to expand its assays onto turbidimetric point-of-care (POC) platforms through partnerships, targeting an attractive adjacent market and potentially extending the reach of the Company's assay portfolio beyond traditional core laboratory platforms. Opportunities within veterinary diagnostics also remain an important part of the pipeline.
Partnership-driven growth. Business development and R&D are increasingly working together to identify and advance opportunities where Gentian's assay development capabilities can complement partners' diagnostic platforms and product portfolios. Several such opportunities are currently being evaluated or developed, supporting a more market- and customer-driven R&D pipeline.
High-sensitivity technology (HST). Development of Gentian's high-sensitivity technology continues as an important strategic initiative. The technology has the potential to significantly expand the range of biomarkers addressable by turbidimetric assays. Development activities are focusing on evaluating potential applications and partnership opportunities as well as generating data to further strengthen company’s unique IP around this technology.
Overall, the Q3 pipeline reflects the intended direction of the updated strategy: a diversified portfolio of partner-driven and internally initiated projects, stronger market alignment, and parallel development activities aimed at increasing the pace and probability of successful product launches.
Ongoing and new pipeline projects
Gentian continues to advance a broader and more balanced pipeline comprising partner-driven development programs, internally initiated projects and new technology opportunities.
The assay development program for a key IVD partner has successfully transitioned from Gentian's research site in Gothenburg to its development organization in Moss, where activities are progressing according to plan. Successful transfer represents an important project milestone and brings the assay closer to the next phase of development. The project remains on track for the planned launch in Q4 2027.
Following the partnership with Essange Reagents announced in June, development activities have been initiated and are progressing as planned. The collaboration is currently focused on four complementary assays, combining Essange's expertise in specialty immunology reagents with Gentian's capabilities in adapting assays for automated clinical chemistry platforms. The parties will evaluate the broader commercial potential of the portfolio beyond the existing interest of a global IVD partner.
Within veterinary diagnostics, Gentian has submitted proposals for two paid development projects to a major veterinary IVD company, including the potential for Gentian to serve as assay manufacturer. During Q3, progress was made towards establishing a new collaboration, although formal confirmation and contractual arrangements remain pending.
The high-sensitivity technology collaboration continues to progress, with the first co-development project advancing to the research prototype development phase. The collaboration represents an important step in evaluating Gentian's technology on turbidimetric point-of-care platforms and supports the Company's strategy of expanding its technology and assay capabilities beyond traditional core laboratory systems. Commercial terms remain under discussion.
In parallel, Gentian continues to advance its internally initiated pipeline. One project focuses on the development of a new PETIA assay targeting an undisclosed clinically relevant biomarker with the potential to complement the existing product portfolio. The opportunity addresses an area of unmet clinical need and attractive long-term commercial potential. A second project is an early-stage exploratory PETIA program focused on a biomarker for the assessment of liver disease, with the potential to provide additional clinical value when used alongside existing markers as part of a broader liver diagnostics panel.
In addition, Gentian is progressing a product improvement project for an existing assay aimed at enhancing product performance, strengthening product quality and improving manufacturing cost efficiency.