The world faces a growing epidemic of antibiotic resistance, however only two new classes of antibiotics have been brought to the market in the last 30 years. The discovery and development of new antibiotics is essential to maintain medical advances but poses significant scientific, clinical, and financial challenges, particularly for antibiotics active against Gram-negative bacteria (such as E.coli). Such bacteria have effective barriers against drugs, making treatment difficult, resistance likely and development costs and risks high. In addition, any new antibiotics brought to the market would likely be used cautiously to delay the development of resistance, adding an additional financial challenge in recouping the development costs. The O’Neill Report on Antimicrobial Resistance (AMR) identifies diagnostics as critical to the battle against antibiotic resistance.
This innovation action, BreathSpec, proposes a viable solution to the global problem of AMR through the final developmental stages of an existing diagnostic device, which will allow a rapid, binary decision to be made on the need for antibiotic treatment, and which with suitable optimisation will allow further differentiation and stratification to take place. The Innovation Action includes technical developments to optimise its function, data acquisition for the development of the decision-making analytical function and clinical validation.
It addresses these issues by producing reliable identification and quantification of key signature volatiles present in exhaled breath. It provides a non-invasive method for monitoring the volatile organic compounds present in an individual’s exhaled breath (and subsequently the blood) and has long been recognised as having significant utility as a clinical test that can be used for early disease detection and monitoring, and potentially to diagnose specific bacterial infections for better, more targeted use of existing antibiotics.
This innovation project has the following objectives:
• To optimise the design and functionality of the existing analytical device for the purpose of breath analysis for microbial volatiles, upgrading sensitivity and selectivity;
• To undertake multi-centre studies using healthy volunteers and patients with known pathologies to generate characteristic data for the production of algorithms to separate bacterial from viral infections;
• Undertake field trials to validate the optimised device with input from key stakeholders including full analytical and clinical validation;
• Generate analytical and clinical data to apply for the necessary regulatory approvals;
• Undertake value engineering and health economics studies to inform the commercialisation process;
• Initiate commercialisation of the product in target sectors/markets through our distribution channels and effective innovation management and dissemination.
