The DECISION consortium is developing a new class of diagnostic platform that will transform the fight against pandemics. The low-cost, miniaturised, disposable molecular diagnostic platform will allow for patient testing virtually anywhere, within a few minutes, with laboratory quality performance. The diagnostic platform will enable rapid detection of Covid-19 infections on-site in a multitude of settings including drive-through testing centres, physician offices, airports, hospitals and quarantine centres. First demonstrators of the disposable molecular diagnostic platform and coronavirus test will be available five months after the start of the project and could be provided to emergency first responders and public health authorities. The platform is powered by a next-generation nucleic acid amplification technology called Pulse Controlled Amplification (PCA®), which enables sample-to-answer workflows in 15 minutes or less. The DECISION consortium is comprised of teams from Italy, Spain and Germany, and is highly motivated to develop a ground-breaking diagnostic solution to help the serious crisis faced across the world due to the Covid-19 epidemic.

The overall goal of this project is to bring the unique, ultra-fast Local Heating PCR technology and its current lab-proven prototype instruments from TRL 4 up to TRL 6 into clinical demonstration in tuberculosis centers in Italy, Latvia, and Tanzania. This will imply a fully automated workflow on the instrument and all necessary reagents onboard of the integrated disposable cartridge, and a cloud based software for tracking epidemiological patterns. The application, ultra-fast point-of-care testing (POCT) for tuberculosis (TB) as well as emerging TB resistance markers, is an unmet healthcare need, not only in Europe, but globally. About one third of the human population is thought to carry the pathogen. One patient with active TB can typically infect 10-15 others. In the EU, the highest incidence rates are observed in Eastern Europe and the Baltic region. Furthermore, a very recent surge has been observed in some EU countries, e.g. in Germany, mainly due to higher mobility and migration. On top of this, multi-drug resistant (MDR) TB strains are becoming epidemic, causing exploding treatment costs. Active tuberculosis needs to be rapidly detected at hospitals, in- and out-patient clinics, specialized TB centers, jails, community centers, and shelter facilities. Such a test should be highly sensitive and capture all of the clinically relevant mutations that confer resistance in TB; if only one mutation escapes detection, the wrong treatment decision might be made, leaving the patient infected and capable of spreading resistant pathogens. Therefore, a panel of multiplexed markers will be adopted to LPCR in this project. It is ultimately the project’s ambition to develop a European-based contender in the emerging molecular POCT system space. The integrated TB/MDR TB LPCR system, a break-through-technology, aims specifically at impacting healthcare, TB knowledge and capacity building, and enabling future commercial success of the products.

There is an urgent need for fast and accurate diagnostic tests in the current Ebola crisis. The rapid diagnosis of EVD during early and late stage of infection is a decisive step for risk assessment and for guidance to physicians to take the necessary decisions to limit the spread of the infection, and to safely nurse the infected patients. While fast and easy-to-use tests usually rely on immuno-diagnostic approaches, they typically lack high sensitivity and specificity. The gold standard for accurate diagnostics, (Real-Time) PCR, however, is limited in terms of processing time, high costs, and in most cases also in terms of ease of use and the need of special laboratory facilities. The aim of this project is to provide an ultra-fast and accurate molecular diagnostic instrument that can perform a molecular Ebola test within 10-15 minutes. Patients, suspected of Ebola Virus Disease (EBD), due to fever and/or other clinical signs, could be rapidly and accurately tested at the Point-of-Care by withdrawal of blood, or less invasive fluids, such as saliva or urine. The core technology of this proposal is based on laser-heated nanoparticles (Laser PCR), overcoming the time-limiting step of heating and cooling the reaction sample in conventional PCR allowing for drastically reduced turn-around times. The project partners (GNA, INMI, MUB, EMG) have the competence to integrate sample preparation with virus-binding magnetic particles, ultra-fast molecular diagnostics with Laser PCR, test the system in a biosafety level 4 laboratory in Rome, Italy, and thoroughly conduct field testing in a medical care centre in West Africa (Sierra Leone). A tentative Ebola Laser PCR assay has already been set up, detecting 10 target copies of synthetic DNA oligos, corresponding to the Ebola genome sequence, in less than 12 minutes. The FILODIAG project will deliver a potentially multiplexed diagnostic system fast enough for point-of need testing of incoming patients at low-resource