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Fast tracking market adoption of a novel immune-based diagnostic for improving antibiotic stewardship: automation, piloting and health economics

Cel

MeMed has completed development of ImmunoXpert™, an in vitro diagnostic test that leverages the body’s immune system to accurately differentiate between bacterial and viral infections. A breakthrough in infectious disease diagnosis, ImmunoXpert™ overcomes limitations of traditional diagnostics, outperforming standard of care. ImmunoXpert™ recently received regulatory European clearance (CE-IVD) and represents a close-to-market innovation. Market entry points include emergency department and hospitalized pediatric patients with respiratory tract infections (RTI) and fever without source (FWS), for which ImmunoXpert™ is uniquely positioned to improve patient management and health economics. In children, RTIs account for 50% of doctor visits and hospitalization. Fever accounts for 10-25% of pediatric ED visits, with as many as 20% without identifiable source. The global market for ImmunoXpert™ diagnosis of pediatric RTI/FWS is €2.8B (EU is €560M).
To fast track market adoption across Europe we propose:
•To transition ImmunoXpert™ from a hands-on laboratory assay to Tecan’s hands-free, rapid automated laboratory platform to increase clinical utility and economic benefit
•To roll-out ImmunoXpert™ to EU pilot hospitals with the goal of managing 1200 pediatric patients to evaluate performance and clinical utility in real working conditions
•To perform health economics analysis and establish reimbursement strategy

AutoPilot-Dx is a cross sector effort (industry, KOLs, outcome researchers) highly aligned with H2020-FTIPilot’s goals and Societal Challenges: it will reduce ImmunoXpert™’s time to market and provide a road-map for sustainable market uptake; a H2020 first-time applicant is involved; the project will enable MeMed and Tecan to scale-up in line with their business strategies; the immune-based diagnostics will improve antibiotic stewardship, providing better, personalized, care for children with RTI/FWS and help fight antibiotic resistance – a global health threat

System finansowania

IA - Innovation action

Koordynator

MEMED DIAGNOSTICS LTD
Wkład UE netto
€ 655 025,00
Adres
NAHUM HETH STREET 5
39120 TIRAT CARMEL
Izrael

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MŚP

Organizacja określiła się jako MŚP (firma z sektora małych i średnich przedsiębiorstw) w czasie podpisania umowy o grant.

Tak
Rodzaj działalności
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Linki
Koszt całkowity
€ 938 250,00

Uczestnicy (5)