Descrizione del progetto
Un test decentrato rileva la resistenza agli antibiotici nei casi di tubercolosi
La resistenza ai farmaci rappresenta una grande sfida medica nel trattamento di molte malattie infettive, inclusa la tubercolosi, responsabile di oltre 1,5 milioni di morti ogni anno. La prescrizione di antibiotici inefficaci aggrava la situazione, e i pazienti devono sottoporsi ad esami per identificare le specie di batteri resistenti ai farmaci. L’obiettivo del progetto mfloDx, finanziato dall’UE, è sviluppare un test diagnostico di facile utilizzo per la tubercolosi in grado di fornire risultati sull’antibiotico-resistenza in meno di tre ore. Il test può essere eseguito fuori dal contesto ambulatoriale con formazione e strumentazioni minime. L’elevata specificità e sensibilità, unite alla convenienza, lo rendono ideale per l’utilizzo in paesi in via di sviluppo.
Obiettivo
Tuberculosis (TB) kills more people than any other pathogen-borne illness; yearly, 10M people fall ill and 1.6M die. TB also contributes to a growing existential crisis: the spread of antibiotic resistant bacteria. Multi-drug-resistant TB is flourishing due to incomplete diagnoses and widespread prescription of ineffective antibiotics. Commercial diagnostics often require equipment in the €12-70K range and are either very slow or incomplete. As a result, less than one-third of new TB patients undergo strain testing to determine whether antibiotic resistance is present.
mfloDx is a low-cost, DNA-based TB diagnostic, similar to home-pregnancy tests. In <3 h, our test identifies nearly 100% of drug resistant TB strains with 92-97% accuracy, directly from sputum samples and with a minimum of lab equipment or training. Clinical validation is ongoing and we are preparing for in vitro diagnostic (IVD) certification for an estimated launch in late 2022. The low cost, accessibility, and stability of mfloDx tests will enable uptake in developing countries, which are the source of much antibiotic-resistant infection.
EMPE‘s team are experts in TB research, business development, and diagnostic tools for infectious disease. mfloDx grew from a molecular innovation called the Padlock probe, developed by our co-founder, Mats Nilsson. EMPE CEO Pavan Asalapuram combined this technology with a lateral flow biosensor, as a fast and accurate kit to identify antibiotic resistance. EMPE has raised ~€2M in seed capital and started clinical validations with partners in Spain and India. Thus far, our facility at Karolinska Institute Science Park produces test kits for research use only (RUO). EIC funding would accelerate clinical validation of our kits toward in vitro diagnostic certification and enable the implementation of large-scale production. This project will enable us to launch our top-of-the-line product and reach a worldwide €3.5B TB diagnostics market with WHO backing.
Campo scientifico
- engineering and technologyelectrical engineering, electronic engineering, information engineeringelectronic engineeringsensorsbiosensors
- medical and health scienceshealth sciencesinfectious diseases
- medical and health sciencesclinical medicinepneumologytuberculosis
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsantibiotics
- medical and health sciencesbasic medicinepharmacology and pharmacydrug resistanceantibiotic resistance
Parole chiave
Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-EIC-SMEInst-2018-2020-3
Meccanismo di finanziamento
SME-2 - SME instrument phase 2Coordinatore
171 65 Stockholm
Svezia
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.