Periodic Reporting for period 1 - NIMM (Fluorescence-based nano-immunoassay IVD platform)
Reporting period: 2019-07-01 to 2021-06-30
Antibody-detection related to disease or to drug monitoring demands novel in vitro diagnosis (IVD) tests that provide robust, rapid and early-stage diagnostics for improved and early onset treatments. However, companies developing novel IVD immunoassays face an important barrier related to reimbursement policy issues when the IVD tests are introduced into national health systems. This barrier discourages many companies from pursuing the development of novel diagnostic tests because the investment necessary to introduce novel IVD tests in the market is hardly matched by the return of the investment. In this context, NIMM focused on providing a platform for the development of accurate, sensitive and inexpensive immunoassays for antibody-related conditions using a novel fluorescent nanosensor-based technology. The main outcomes of the project are the selection of antigen systems derived from viral proteins for the detection of anti-viral antibodies. The successful fusion of these antibodies to a unique engineered protein module enables the stabilization of fluorescence metal nanoclusters. The validation of the technology for the detection of anti-hepatitis C virus antibodies using fluorescence anisotropy and the validation of an alternative fluorescence life-time detection technology for the detection of anti-SARS-CoV-2 antibodies. These new nanosensors show promise as new tools for point of care in vitro diagnostic systems. NIMM project moved from the research and development phase to commercial deployment, securing additional funding for the progress of the project and making a comprehensive market analysis that ensures profitable development of the technology in the infectious disease market. From this market analysis NIMM resulted in the design of a value proposition to market the technology through the future creation of a start-up company.