Periodic Reporting for period 2 - CoNVat (Combating 2019-nCoV: Advanced Nanobiosensing platforms for POC global diagnostics and surveillance)
Reporting period: 2021-03-10 to 2022-09-09
At the end of the project, we have upgraded the proposed biosensor in terms of integration and multiplex capabilities. We have demonstrated the detection of intact SARS-CoV-2 viruses with the photonic biosensor, with a time analysis of less than 15 min, with a very high sensitivity, which has set the basis for its future implementation for COVID-19 diagnosis. The genomic approach has not been fully validated as the sensitivity achieved remains slightly low for the analytical requirements. These aspects remain to be finalized in the coming weeks. Overall, CONVAT project has reached crucial milestones towards introducing a unique and powerful technology as a novel diagnostic solution for dealing with emerging pandemics and bettering general healthcare: point-of-care testing, rapid and accurate analysis, high sensitivity and specificity, and easily adaptable to different targets including proteins, nucleic acids, viruses or bacteria.
- Collection of clinical human samples (20.000) and animal reservoir samples (350). A part of them has been fully characterized.
- High quality biological reagents for diagnostics, including viral antigens, antibodies, genomic material, and inactivated virus samples have been produced.
- A photonic biosensor-based serology test for the detection of specific antibodies generated after infection has been established and fully validated with more than 100 clinical samples, demonstrating excellent diagnostic sensitivity and specificity.
- A biosensor methodology for the direct detection of intact SARS-CoV-2 viruses has been set up, demonstrating the detection of viruses in less than 15 min, with a sensitivity of around 100 FFU/mL.
- A direct hybridization assay for the detection of SARS-CoV-2 RNA strains has been evaluated. The sensitivity achieved at the end of the project has not been sufficient for the analysis of real samples, and additional efforts have been concentrated on the sensitivity enhancement.
- The BiMW biosensor prototype is being upgraded and prepared for integration and portability. Work has been done in microfluidics design, BiMW multiplexing sensor chips fabrication, electronics integration, signal readout, and software.
The CoNVAT technology have attracted huge interest from industry and investors, as well as the social and scientific media, and general population. At the European level, the CoNVat project has been mentioned in nearly 200 individual pieces globally and has also been publicized and participated in institutional communication channels.
The project has delivered relevant data related to SARS-CoV-2 molecular characterization and diagnostic tools which are shared in open-access repositories and platforms like the EVAg and GISAID, available for researchers, industrials, and the general population. Moreover, the CONVAT project and the results have been presented and shared in scientific publications (33 peer-review journals, conferences, and workshops). We have been contacted by a large number of international small, medium and large companies and private investors to know more about the maturity and the degree of development of the biosensor tests. The exploitation roadmap is essentially focused on the technological transfer of biosensor devices and approaches as in-vitro diagnostic systems. Several exploitable results included the photonic biosensors employed and upgraded during the project, the serology and virus detection assays, and the methodologies for sensor chip biofunctionalization and storage. Related to the serology assay, ICN2 has registered three Trade Secrets related to the technology and the assay. The excellent track-record of the ICN2 partner in developing optical biosensors for biomedical and clinical applications, together with the good results achieved during the CONVAT project, has boosted the upcoming creation of a new spin-off company for the commercialization of the photonic biosensors as new in-vitro diagnostic (IVD) systems.
The scientific research carried out within the CONVAT project has delivered relevant data shared in open access repositories and platforms like the EVA, available for researchers, industrials, and the general population. Moreover, the CONVAT project and resultant outcomes have been presented and shared in nearly 100 online conferences and more than 30 peer-review articles have been already published. Outside academia, CONVAT has attracted massive attention from the media and the general society, mainly at the Spanish national level but also at European and International level, contributing to increasing the outreach of the research carried out. It has been mentioned in more than 300 interviews and stories so far, published in television, radio, and press. We expect that the technology output of CoNVat will become a strong competitor in existing markets of in vitro diagnostics and will open possibilities in potentially larger new markets, such as that of bacteria diagnosis and antimicrobial profiling, among other applications for IVD in the clinical practice.