About the project

TECHNICAL CLUSTER “INSIDE THE BREATH”

Early diagnosis of tumors? In a breath.

Analysis of gaseous metabolites present in human exhalation for ‘smart’ diagnostics

No more invasive blanket tests. To identify the most common pathologies, it is now enough to analyze the human breath.

This is thanks to the “Inside the breath” multidisciplinary clusterfunded by the Puglia Regionthrough its “Aid in Support of Regional Technology Clusters for Innovation”.

This research and pre-production project at the University of Bari, supported by three Puglian companies, aims to develop a ‘smart’ diagnostic system: that is, a lightweight machine, with zero-impact on patients and maximum reliability. Simply by breathing into this apparatus (similar to a spirometer), one will get a clear indication of the presence of a certain pathology. How?

The ‘breathomica’ is a recent scientificadvance. The apparatus analyses volatile organic compounds (VOCs) in the exhaled breath, and is able to interpret the presence of gaseous metabolites and then create prediction models. The chemical-biological-health research that has led to this advance is integrated with the engineering design of the machine, which, by recording the composition of a patient’s breath, will be able to analyze the data and provide a diagnosis.

The benefits of this new technology are significant: lower costs for the national health service and a reduced need for some current diagnostics (colonoscopy, blood tests, mammographs, etc.), which will help to shorten patient waiting lists as well asreduce suffering, especially amongst weaker and elderly patients.

Multidisciplinary collaboration and highly specialized expertise are the two distinctive features of the Cluster.

The leading company is Predict Srl, a specialist in diagnostic imaging systems, whose task is to develop the technology and software for analyzing gaseous metabolites in the exhaled breath, to create the breathomica database and to design the prototype of the equipment.

The University of Bari (Faculty of Medicine, Department of Emergency and Organ Transplantation and Department of Biology) is contributing to the project with 10 researchers, coordinated by Professors Donato Francesco Altomare and Gianluigi De Gennaro. Authors of numerous scientific articles on the breathomica, they are part of the team that, for the first time in the world, has demonstrated the ability to diagnose colorectal cancer by analyzing the exhaled breath. They have the task of transferring basic research to the market, finalizing it not only in relation to the early diagnosis of colon cancer, but also to other diagnostic fields.

Wel.Co.Me. Srl, a spin-off of the University of Bari, is concerned with applying a model for evaluating the effectiveness of the technology on direct beneficiaries as well as in terms of its social and economic impact on the entire community.

RetiMeridiane, a consortium of social cooperatives, is carrying out systematic surveys on the ground, by different types of patients, and guaranteeing their sampling and analysis.

Thanks to equipment that the Department of Biology acquired under another project funded by the Puglia Region, “VOC & ODOR: Networks of Public Research Laboratories”, it is also possible to undertake an off-line analysis of the exhaled breath collected in a bag. The tool that is being developed will be able to diagnose multiple pathologies: gastrointestinal, respiratory, central and peripheral nervous system, respiratory tract infections, obstructive sleep apnea, and breast, genital and prostate cancers.

The ‘Inside the Breath’ research has a defined timeline: by 2018, the prototype of the mass-screening device for colorectal cancer will be presented, and prevention activities can begin, starting with the elderly population. Due to the inherent danger of this disease, many parts of Italy have been running screening campaigns for years.

This smart device, which allows early, pain free diagnosis for the patient and can reduce public health costs, would be an innovation that potentially affects 23% of the Italian population (those over 65). But research will not stop there: it will carry on into developing tools to diagnose different pathologies. The next step, already defined in the project, is about infantile asthma. From seniors to children, for the common good.

Many of the currently used diagnostic procedures are invasive. The output from this project,by contrast, is a handy and safe instrument for the early diagnosis of numerous pathologies. It is able to recognize the metabolites, produced by pathological cells, thatare transported through the blood to the lungs, then exchanged in the gaseous phase and finally expelled with the exhaled breath. Patients who have already undergone the ‘off line’ test have reported a high level of acceptability for this method, finding it more tolerable than traditional diagnostic methodologies.

Breath analysis has the potential to represent a truly innovative diagnostic approach. The University of Bari is among the leading research groups worldwide engaged in experimental studies of great scientific and social importance on colorectal cancer, as evidenced by the numerous scientific publications in international journals.

[Altomare et al. ‘Exhaled volatile organic compounds identify patients with colorectal cancer’. Br J Surg. 2013;
Altomare, et al. ‘Effects of Curative Colorectal Cancer Surgery on Exhaled Volatile Organic Compounds and Possible Implications in Clinical Follow-up’. Ann. Surg. 2016;
De Gennaro et al. ‘Chemical characterization of exhaled breath to differentiate between patients with malignant plueral mesothelioma from subjects with similar professional asbestos exposure’. Anal Bioanal Chem. 2010]

The ‘off line’ service with sample collection in bags and analysis at the Department of Biology at the University of Bari is already available.

The ‘Cluster’ project also provides for the engineering of a prototype – starting with the experimental setup used so far – which will be available by October 2018. The numerous requests for clinical testing with this method have enabled the development of a first working prototype, already being used for the diagnosis of some diseases since February 2017.

The breath analysis technology is completely transferable and usable on various pathologies. By changing the pattern of identifying the molecules of the pathologies under study and the logic of disambiguating the different signs of healthy and sick patients, it is possible to transfer the technology developed to a variety of pathologies (colorectal cancer, lung, breast and prostate cancers, as well as asthma and infantile bronchitis). In Italy, other research centers are also developing breath analysis methods, but none of them has a system designed to be independentof analysis in a chemistry lab. For this reason, Puglia could become an attraction and reference point for the technological development of this method. In fact, this is already happening on the front of scientific research between the University of Bari and the Universities of Chieti and Trieste.

Methods for determining gaseous metabolites in the exhaled form are expected to be the use of a sampling system for collectingthe exhalation, an analytical system (a gas chromatograph and a series of sensors) for detecting volatile organic compounds and inorganic gases and a data processing and analysis system that can improve its accuracy and reliability through learning machines. The latter works in the Cloud and provides responses in IoT mode.

In summary, the diagnostic apparatus consists of a sampler, detectors and a data processing system.

The goal of the ‘Inside the breath’ project is to bring complex and bulky systems into one single device by designing an ‘all in one’ solution that can work stand-alone even outside a chemistry lab. In this way, clinical practice can be mademore autonomous. A test could be takenat a pharmacy, for instance, like other self-diagnosis services. Test compliance is guaranteed by the use of ‘medical grade’ materials and by certified instruments for the analytical characterization. Standard DIMSE-DICOM will guarantee interoperability in the transfer of information.

 

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