G-1001

Millioner av mennesker over hele verden lider av hjertesykdommer. Den globale belastningen av hjertesykdom øker raskt med aldring av befolkningen, og det er et av de viktigste globale folkehelseproblemene. Diagnose utføres tradisjonelt ved undersøkelser som elektrokardiografi eller ekkokardiografi, som både er tidkrevende og kostbart. Internasjonale retningslinjer anbefaler bruk av biomarkertesting i diagnostisk opparbeidelse. Med den aldrende befolkningen og den globale belastningen av hjertesykdommer på helsesystemet vårt, ville en diagnostisk test for raske, billige kliniske kjemianalysatorer være svært fordelaktig for pasienter, laboratorier og helsevesenet generelt. I dette prosjektet har norske SMB Gentian AS jobbet med å utvikle en diagnostisk test for hjertesvikt (HF) basert på vår patenterte nye teknologi. Denne teknologien muliggjør for første gang utvikling av en test for hjertebiomarkør NT-proBNP på helautomatiserte, høykapasitets (mange tester/time) kliniske instrumenter.

OUTCOMES Gentian’s NT-proBNP assay aims to be the first turbidimetric in vitro diagnostic test for the quantitative measurement of NT-proBNP. The goal is to make NT-proBNP testing more accessible on high-volume clinical chemistry analysers, which will increase laboratory productivity and reduce overall costs. The growing cost burden in healthcare systems due to an aging population and lifestyle choices is driving an increase in the demand for NT-proBNP testing. We expect sales to ramp up more quickly than it does for tests that still need to gain acceptance. Crucial shortcomings in competing assays that our product addresses will allow Gentian to capture a substantial market share. IMPACT More than 26 million people worldwide are suffering from heart failure (HF) and cardiac disfunction. The global burden of HF and cardiac dysfunction is increasing rapidly with the aging of the population, and it is one of the main global public health problems. A rapid, cost-effective test for Heart Failure will help address this issue.

In this project, Norwegian SME Gentian AS will further research, develop, optimize, validate and bring to market a cardiac diagnostic test based on our patented new technology. This technology enables, for the first time, development of a test for this biomarker on fully automated, high-throughput clinical analyzers. The primary objective for the R&D activities in this project is to further develop and optimize a highly sensitive, robust immunoassay for turbidimetric clinical analysers, validated by solid clinical trials. The anticipated main result is a cost-effective, rapid, and highly sensitive diagnostic product that is commercialized successfully on the world market. Secondary objectives - Investigate antibody properties to obtain those with high affinity and strong binding properties - Develop a coating process that will lead to binding most possible antigen - Gain more specific knowledge on the binding of the antibodies to the antigen epitopes - Gain more knowledge on the secondary structure of the antigen / biomarker - Develop stable reagents (storage, onboard, transport, etc) - Establish a reference standard that better matches actual values in the blood - Establish clinical usefulness of the test