Gentian Diagnostics ASA announced 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. 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.