G-1001

Millions of people worldwide are suffering from cardiac diseases. The global burden of cardiac disease is increasing rapidly with the aging of the population, and it is one of the main global public health problems. Diagnosis is traditionally performed by examinations such as electrocardiography or echocardiography, which are both time-consuming and expensive. International guidelines recommend the use of biomarker testing in the diagnostic workup. With the aging population and the global burden of cardiac disease on our health system, a diagnostic test for rapid, low-cost clinical chemistry analyzers would be highly beneficial to patients, laboratories and the health care system in general. Current state-of-the-art technology for analyzing low-concentration disease markers are separation-based (heterogenous) multi-step assays on immunochemistry analysers. These types of assays are highly sensitive and can detect concentrations as low as 0.1µg/L, sometimes even lower. In this project, the Norwegian SME Gentian AS worked on a diagnostic test for heart failure (HF) based on our patented new technology. This technology enables, for the first time, development of a test for cardiac biomarker NT-proBNP on fully automated, high-throughput (many tests/hour) clinical analyzers.

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