Project description DEENESFRITPL Containing COVID-19 with rapid tests Testing is a critical cornerstone of the COVID-19 response. While molecular tests were rolled out within a month of the virus being sequenced, these are laboratory based. Rapid tests are necessary to detect the presence of the virus anywhere. These rapid tests are also faster and cheaper. As such, these tests are vital to contain and fight COVID-19. With this in mind, the EU-funded KRONO project is developing a lyophilised assay for direct detection of the coronavirus from nasal swab samples. This test can be conducted anywhere. The project will test its lyophilised assay. Research will document quantified standards and performance evaluation data under its ISO13485 quality standard and generate data for Emergency Use Authorisation regulatory approval. Show the project objective Hide the project objective Objective This project focuses on rapid (40min), simple, Point-of-Need COVID-19 testing, e.g. surgery/home (via first responders)/transit points of entry. BG Research (BGR) has developed direct from crude sample detection of viral pathogens – the QuRapID-XF technology, removing requirement for nucleic acid extraction, expert users or a laboratory; results delivered while you wait. Tests utilise the Gold Standard polymerase chain technology as current clinical reference tests, but using our novel reagent, directly breaking open the virus and a single enzyme system that is resistant to the inhibitory compounds found in crude biological samples. Objectives:1. Develop a lyophilised assay for direct detection of SARS-CoV-2 from nasal swab samples.1. Production scaling of a portable instrument for performing the test at Point-of-Need.2. Demonstration of a pipeline for rapidly deploying new assays in response to future outbreaks and detection from a wider range of sample types.3. Validation of the assay at 3 independent sites using clinical samples, generating data sets for regulatory approval.Achieving the objectives:BGR has pre-production portable systems in testing for the in-field detection of veterinary diseases from animal nasal swabs. This project will bring scaled production of the product forward by minimally 3 months together with a validated lyophilised SARS-CoV-2 assay. The team has proven experience in diagnostics design and development and will have access to clinical patient samples from Italy and France, generating quantified standards and performance evaluation data that BG Research will document under its ISO13485 quality standard and generate data for EUA regulatory approval.Relevance to Work P:The IMI2 call is seeking innovative diagnostics to have impact in combating the current Coronavirus outbreak and this proposal to provide rapid and simplified differential diagnostics at the point of need, is directly aligned with the scope. Fields of science natural sciencesbiological sciencesbiochemistrybiomoleculesnucleic acidsmedical and health sciencesclinical medicinesurgerynatural sciencesbiological sciencesmicrobiologyvirologymedical and health scienceshealth sciencesinfectious diseasesRNA virusescoronavirusesnatural sciencesbiological sciencesbiochemistrybiomoleculesproteinsenzymes Keywords Point-of-Need Molecular Diagnostics RT-qPCR SARS-CoV-2 Portable COVID-19 Rapid Diagnostics Simple Diagnostics Multiplex Diagnostics Pan Flu SARS MERS Flu Virus X Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.7. - Innovative Medicines Initiative 2 (IMI2) Topic(s) IMI2-2020-21-01 - Development of therapeutics and diagnostics combatting coronavirus infections Call for proposal H2020-JTI-IMI2-2020-21-single-stage See other projects for this call Funding Scheme RIA - Research and Innovation action Coordinator UNIVERSITE D'AIX MARSEILLE Net EU contribution € 321 750,00 Address Boulevard charles livon 58 le pharo 13284 Marseille France See on map Region Provence-Alpes-Côte d’Azur Provence-Alpes-Côte d’Azur Bouches-du-Rhône Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Participants (4) Sort alphabetically Sort by Net EU contribution Expand all Collapse all ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI-ISTITUTO DI RICOVERO E CURA A CARATTERE SCIENTIFICO Italy Net EU contribution € 246 250,00 Address Via portuense, 292 00149 Roma See on map Region Centro (IT) Lazio Roma Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 B G RESEARCH LTD United Kingdom Net EU contribution € 28 750,00 Address Biogene house 6 the business centre harward way PE28 0NJ Kimbolton See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region East of England East Anglia Cambridgeshire CC Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 622 368,75 UNIVERSITE DE CORSE PASCAL PAOLI France Net EU contribution € 187 720,00 Address Avenue du neuf septembre bat jean toussaint desant 20250 Corte See on map Region Corse Corse Haute-Corse Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 BIOGENE LTD United Kingdom Net EU contribution € 0,00 Address Bio gene house, 6 the business centre harvard way kimbolton PE28 0NJ Cambridgeshire See on map Region East of England East Anglia Cambridgeshire CC Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 413 125,00