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RAPP-ID Development of RA pid P oint-of-Care test P latforms for I nfectious D iseases. Herman Goossens, MD, PhD Academic Coordinator University of Antwerp, Belgium Jorge Villacian, MD Project Coordinator Johnson & Johnson, Belgium.
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RAPP-IDDevelopment of RApid Point-of-Care test Platforms for Infectious Diseases Herman Goossens, MD, PhD Academic Coordinator University of Antwerp, Belgium Jorge Villacian, MD Project Coordinator Johnson & Johnson, Belgium
Why do we need better Rapid Point-of-Care Tests? • There has been under-investment in rapid diagnostics for improving the quality of care for patients with suspected infections: • Diagnostics influence 60-70% of health care decision making but account for less than 5% of hospital costs (Lewin report 2006) • POCTs improve antibiotic targeting to only those who will benefit, thus reducing overuse: • The commonest reason for prescribing antibiotics in the community is acute cough, and these prescriptions virtually never benefit patients (Butler et al, BMJ 2009)
Why do we need better Rapid Point-of-Care Tests? • POCTs enhance surveillance of pathogens and infectious diseases: • e.g. H1N1 flu pandemic • POCTs support rapid initiation and cessation of treatment: • Sepsis is associated with 7% increased mortality for every hour delay in the administration of appropriate antibiotics (Kumar el al, CCM 2006). • POCTs decrease the size and cost of antibacterial clinical trials: • We URGENTLY need new antibiotics (ECDC/EMA report 2009)
Why did Industry and Academia Fail? Can you imagine the challenges of shrinking a huge laboratory filled with people and equipment onto a single chip the size of a matchbox? Neither industry, nor academia can do this on their own! Ziober et al. Head Neck 2008
Overall Objective RAPP-ID will develop a Point-of-Care Test (POCT) for rapid (hospital <2h, primary care <30min) detection of bacteria, mycobacteria, fungi, as well as viruses and host biomarkers by combining novel specific probes, novel methods of sample preparation, and demonstrated ultra-high sensitive detection methods. The platforms will also determine resistance to antimicrobial drugs
RAPP-ID Meets Clearly Defined Clinician Needs Sepsis Lower Respiratory Tract Infections (LRTI) Community-Acquired Pneumonia (CAP) Ventilator-Associated Pneumonia (VAP) Tuberculosis (TB)
Consortium Synergies • Academic partners: • Expertise in European Projects • Innovative technologies • Clinical expertise • Samples/Laboratory capabilities • SME: • Innovative technologies • Flexible attitude • EFPIA • Industry perspective • Expertise in clinical development • Regulatory and communication expertise • Samples/Laboratory capabilities
Why Should RAPP-ID Succeed? • IMI is a unique instrument of joint academia-industry initiatives, and this is the ONLY way to successfully develop POCT for Infectious Diseases • RAPP-ID partners have built up experience in other EU funded projects (GRACE, InTopSens, TheraEDGE, ...) • RAPP-ID provides a unique combination of a whole range of novel assays and technologies • POCT development will not only be “pathogen or technologically driven’ but also designed to meet clearly defined clinical needs with optimal integration and implementation into diagnostic/clinical algorithms and healthcare programs