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  • Periodic Reporting for period 1 - BreathSpec (A rapid, non-invasive, cost-effective, analytical device for bacterial or viral infection diagnosis through ultra-high sensitivity breath analysis.)

BreathSpec Report Summary

Project ID: 755667

Periodic Reporting for period 1 - BreathSpec (A rapid, non-invasive, cost-effective, analytical device for bacterial or viral infection diagnosis through ultra-high sensitivity breath analysis.)

Reporting period: 2017-05-01 to 2018-04-30

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The work undertaken during the period related to appropriate governance and sponsorship required for the clinical trials. This required specialist contracting and appreciate insurance. LSTM has provided this. All subcontracting sites have been identified and contracts are near completion.

The main results related to the ethical documentation and protocol. All required ethical considerations have been incorporated into the ethics and governance process of the clinical trial. This has resulted in a favourable opinion from the REC and fulfilment of requirements by the HRA. Localised R&D departments are now assessing the documentation. GAS has developed and produced 16 prototype Breathspecs to the project. These have been tested and rigorously QA/QC.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The development of the Breathspecs has exceeded state of the art by undergoing significant development to make this a lighter, more patient friendly breath sampler. Feedback from clinicians and end users led to different design iterations in the BreathSpec mount and mouth piece holder design. The BreathSpec is currently the only commercially available breath analyser capable of robust deployment at the bedside for trace analysis.

The project is pushing the boundaries of cutting edge technology by translating lab based volatile organic compound (VOC) analysis into a point-of-care setting. This novel approach has the potential to be multiplexed for other medical diagnoses via the breath and therefore would be cutting edge. The development of the prototypes and deployment in multiple settings, has never been undertaken on this scale before.
There are technical, commercial and socio-economic benefits to this project. It is anticipated that if a rapid breath test with high predictive values, were available, then the system would be introduced in the UK with enormous positive impact on the socio-economic factors of patients.

As GC-IMS technology has very good predictive values for other health applications, there is an anticipation that the project would lead the way in fulfilling the market demand of improved antibiotic stewardship, generated in the UK. The project outcomes and results anticipated in Period 2 meet a very important healthcare need by:
•reduceing unnecessary prescription of antibiotics in RTI and complements initiatives to improve antibiotic stewardship in the NHS.
•reducing the number of community acquired pneumonias which leads to hospitalisation and even death with extensive costs to the NHS and related services.

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