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BIA-Brukerstyrt innovasjonsarena

G-1001

Alternative title: G-1001

Awarded: NOK 14.0 mill.

Project Number:

309908

Project Period:

2020 - 2024

Funding received from:

Organisation:

Location:

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. In this project, Norwegian SME Gentian AS will further research, develop, optimize, validate and bring to market a diagnostic test based on our patented new technology. In the first year (2020) of the project, we will concentrate on the development of the seperate assay components, such as the antibodies, immunoparticles, buffers, controls and calibrators. In the second year (2021), we will work on the development of a relevant reference method, and further optimization of assay components.

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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

Funding scheme:

BIA-Brukerstyrt innovasjonsarena