Moss, 28 June 2024
Gentian Diagnostics ASA, a fast-growing developer and manufacturer of diagnostic tests, is pleased to announce the completion of a major milestone relating to the NT-proBNP assay development. The Company has now successfully completed the optimisation phase of the project.
The remaining phases of development include verification and validation. As highlighted in the first quarter report, the final calibration steps have been deferred to the verification phase to align with the availability of additional clinical data. Following successful completion of these phases, Gentian Diagnostics aims to introduce the assay as a research-use-only product in the second half of 2025. The timeline for a full commercial launch will be subject to capacity constraints with external regulatory clearance institutions, a process beyond the company's control. Typically, this regulatory clearance process takes 6-12 months.
“The team has demonstrated unparalleled dedication and ingenuity in their pursuit of innovation to overcome the complexities in developing this assay. We have gained tremendous experience and pushed the boundaries regarding measurement of low concentrations and assay sensitivity beyond what was previously thought possible with ground-breaking advances in the field of high throughput diagnostics. It has also brought invaluable learnings to the company that may benefit and enhance the development of other assays,” said Njaal Kind, acting CEO of Gentian Diagnostics.
Measuring NT-proBNP levels support diagnosis of heart failure. The Gentian assay will be the first test of its kind available on high-throughput analysers which should increase laboratory productivity and reduce overall costs. By uniquely targeting non-glycosylated areas of the molecule, the turbidimetric Gentian NT-proBNP assay measures the total amount of NT-proBNP, unlike most current commercial tests which bind to glycosylated regions of NT-proBNP molecule.
About Gentian Diagnostics
Gentian Diagnostics (OSE: GENT), develops and manufactures high-quality, in vitro diagnostic reagents. Gentian’s expertise and focus lies within homogenous immunoassays, specifically infections, inflammations, kidney failures and congestive heart failures. By converting existing and clinically relevant biomarkers to the most efficient automated, high-throughput analysers, the company contributes to saving costs and protecting life. Gentian 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.
IR contact: Njaal Kind, CEO njaal.kind@gentian.no +47 919 06 525 (mobile)
This information is considered to be inside information pursuant to the EU Market Abuse Regulation (MAR) and is subject to the disclosure requirements pursuant to MAR article 17, Section 5-12 the Norwegian Securities Trading Act. This stock exchange announcement was published by Ole Sørlie, Business Controller and IR at Gentian Diagnostics ASA on the date and time provided.