Gentian Diagnostics ASA announces an update on the development of its NT proBNP assay. Recent investigations have confirmed that the current assay version does not demonstrate sufficiently robust performance in the lower concentration ranges, particularly around clinically important cut off levels.
Based on these findings, Gentian has identified several measures that may enhance assay performance; however, these require a redesign of the test. The company has therefore initiated activities to investigate whether redesigning the assay could improve robustness, with initial results to be shared once available.
At the present stage, Gentian is not able to provide a reliable updated timeline for the release of the Research Use Only (RUO) product nor for the subsequent commercial launch of the NT proBNP assay. The company expects to present revised development timelines during Q2 2026. Consequently, the planned NT proBNP webcast will also be postponed.
Commenting on the development, Gentian CEO Matti Heinonen said:
“This is certainly a disappointing development and a setback for the project. As the assay did not meet the performance requirements needed to pass the verification stage, we have decided to return the project to the optimisation phase. This approach carries a higher level of development risk, but it is necessary as we now evaluate whether a redesigned assay can deliver a viable and commercially relevant NT proBNP product.”
For further information, please contact:
Njaal Kind, CFO
njaal.kind@gentian.no
+47 919 06 525
About Gentian Diagnostics
Gentian Diagnostics (OSE: GENT), develops and manufactures high-quality, in vitro diagnostic reagents. Our mission is to innovate diagnostic efficiency for better treatment decisions. Gentian’s expertise and focus lie within immunoassays, specifically for infections, inflammation, kidney disease and heart failure. By converting existing and clinically relevant biomarkers to the most efficient, high-throughput analysers, the company contributes to saving costs and protecting life. Gentian Diagnostics is headquartered in Moss, Norway, serving the global human and veterinary diagnostics markets through sales and representative offices in Sweden, USA, and China. For more information, please visit www.gentian.com.