East Midlands Breathomics Pathology Node (EMBER)

Our vision is to establish the East Midlands Breathomics Pathology Node (EMBER) as a centre-of-excellence to ensure the development of novel breath analysis tests to help understand disease processes and clinical decision making. This will help develop new ways to improve the way we can chose the right treatment for the right patient.

Measuring breath is familar to us all in the setting of the breathalyser to detect alcohol levels, but perhaps less well known is that exhaled breath contains lots of substances known as volatile organic compounds (VOCs) derived from the lung itself and from more distant organs. Recent advances in technology allow the pattern and quantity of these VOCs to be measured rapidly in patients in hospital, the doctors clinic and potentially at home. The patterns of these substances varies between diseases and can distinguish between different types of the same condition. The range of clinical conditions for which breath tests could be useful is very large. EMBER will intially focus upon respiratory infections, lung cancer, chronic respiratory disease such as asthma and chronic obstructive pulmonary disease, and cardiovascular disorders such as heart failure.

The main barrier to advancing breath analysis as a routine test is that its development requires bringing together a large multi-disciplinary team of scientists and clinicans that are experts in breath analysis to work with the NHS, industry and patients to make these ideas a reality. The East Midlands has a unique and congruent group of clinical and analytical researchers drawn from the University of Leicester (UoL), the University Hospitals of Leicester NHS Trust (UHL) and Loughborough University (LU) with strengths in clinical research, analytical chemistry, data management and mathematical analysis of complex data. EMBER will focus these combined strengths, and co-ordinates existing collaborations with industry partners to create a nationally-leading centre in breath analysis with the critical mass to establish world-class delivery of new technology to the clinic, and training today's and the future scientists and health care professionals.

EMBER will deliver near-patient and remote sensing technologies to analyse breath. We shall rigorously test these technologies in different diseases and in different health care settings such as acute hospitals, secondary and primary care and in the home. We shall include vulnerable patient groups such as the elderly with complicated multiple diseases and children in whom blood tests are more challenging. EMBER will ensure the usefulness of these tests so that their application brings economic and health benefits by helping to make the right decisions in choosing the right treatment for patients.

We will establish the East Midlands Breathomics Pathology Node (EMBER) to develop novel breath-based systems for molecular pathology.

Exhaled breath contains volatile organic compounds (VOCs) that reflect biological processes occurring within the lung and, via the vena cava, more distant organs. Analysis of VOCs in breath provides rapid, at-patient and in clinic non-invasive approaches for diagnosis, phenotyping and stratifying patients. Importantly the range of clinical conditions is large and includes: respiratory infections, cancers, respiratory disease such as asthma and chronic obstructive pulmonary disease, and cardiovascular disorders such as heart failure.

The East Midlands has a unique and congruent group of clinical and analytical researchers drawn from the University of Leicester (UoL), the University Hospitals of Leicester NHS Trust (UHL) and Loughborough University (LU) with strengths in clinical research, analytical chemistry, data management and mathematical modelling of complex data. EMBER focusses these combined strengths, and co-ordinates existing collaborations with industry partners to create a nationally-leading centre in "Breathomics" with the critical mass to establish world-class delivery of new technology, applications and training in molecular pathology.

EMBER will deliver near-patient and remote sensing technologies to analyse breath and by consolidating the assets and expertise across the consortia build an infrastructure that will result in novel methods to analyse complex "omics" data that will be applicable ultimately to many areas of diagnostic pathology; translated from EMBER's leadership in the analysis of breath signatures.

EMBER will impact upon the development, validation, and adoption of the molecular characterisation of exhaled volatile organic compounds-'breathomics' as a next-generation pathology.

A major impact of EMBER will be the training of current and future clinical and basic scientists in this novel "omics" pathology.
EMBER will impact upon stratified medicine with benefits for:

1) Clinicians with improved diagnostics and biomarkers to predict response to interventions and natural history of disease,

2) Patients by improved clinical decision making with new near-patient, non-invasive technologies that are widely applicable with benefits extending to patient groups that present challenges for other molecular pathologies due to difficulties in accessing samples e.g. children and the elderly,

3) Health care providers with more optimised and appropriate allocation of resources,

4) Pharmaceutical industry- 'breathomics' as a pharmacodynamic outcome in early phase development, as a biomarker to select patient groups for late phase trials, and as a companion diagnostic in the clinic,

5) Platform technology industries- improvements in the development of novel devices with clinical applications and the embedding this new molecular pathology in health care.

We predict that EMBER's impact will therefore be transformative in developing high-quality biomarkers and analytical technologies with impacts upon economy and health.