Problem to Be Addressed: It is often difficult for a clinician to decide if a feverish person is suffering from a bacterial or viral infection, as the clinical symptoms can be similar (e.g., sore throat, runny nose, etc.). This seemingly simple problem leads to antibiotic overuse -- the prescription of antibiotics to patients with viral infections, for which the drug is unhelpful. Inappropriate antibiotic use is contributing to the increasing numbers of bacteria resistant to antibiotics, resulting in infections that cannot be treated or that require more expensive and potent antibiotics. There is emerging consensus from stakeholders across the world, including the World Health Organization, European Commission, UK and USA governments, that a key intervention required to tackle rising antimicrobial resistance is the development and adoption of improved diagnostics that enable more prudent use of antibiotics.

Topic Area: The heart of the proposal is a novel point-of-care (POC) diagnostic product, called ImmunoPoC™, which interprets the patient’s immune response to provide an accurate test result that reports if the infection is viral or bacterial. The ImmunoPoC™ blood test will help the military clinician decide which patients require antibiotic (and which do not), leading to improved health outcomes as well as reduced antibiotic misuse, and ultimately, will help curb the rise of antibiotic resistance. In this way, the proposal addresses Fiscal Year 2016 (FY16) Peer Reviewed Medical Research Program (PRMRP) Topic Area “Antimicrobial resistance” and FY16 PRMRP Area of Encouragement “diagnostic tests to limit the prescription of antibiotics for conditions that are commonly viral ...” and more generally, aligns with the FY16 PRMRP vision to improve the health and well-being of all military Service members, Veterans, and beneficiaries.

Proposed Project: The proposal builds on over 6 years of research and development culminating in the ImmunoPoC™ prototype. The present proposal concerns work to overcome key barriers to adoption of ImmunoPoC™ by the US military, namely introduction of connectivity (to enable secure and consolidated management of multiple ImmunoPoC™ devices deployed by the military), transition to Good Manufacturing Practice (GMP) manufacturing (required for Food and Drug Administration [FDA] clearance), and demonstration of its performance on 1000 US military patients (data will be used to support FDA clearance). Unlike civilian clinical studies, the proposed study will be enriched for participants aged 18-45 and will focus solely on US Service members, Veterans, and/or beneficiaries. The clinical study will be designed and executed in collaboration with the Naval Health Research Center (NHRC), San Diego.

Applicability and Impact of the Research: The shorter term impact of the proposed research will be facilitated FDA clearance, enabling adoption of ImmunoPoC™ by the US military, potentially leading to improved health outcomes as well as reduced antibiotic misuse. The longer term impact will be to help curb the rise of antibiotic resistance. This new diagnostic will be applicable to the general public, and similarly anticipated to improve health outcomes and contribute to reducing prescription of antibiotics to patients with viral infections.