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Smart Phone for Disease Detection from Exhaled Breath

Periodic Reporting for period 4 - SNIFFPHONE (Smart Phone for Disease Detection from Exhaled Breath)

Reporting period: 2018-02-15 to 2019-02-14

"Screening for early detection of a disease is required to reveal groups of individuals from the general population in whom the likelihood of the disease is increased and who could benefit from further medical evaluation. The ideal screening test is high-accuracy, low-cost, non-invasive, easily repeatable, effortlessly operated by a lay-person and has minimal impact on the subject's daily activities. In the SNIFFPHONE project, we aim to tackle these requirements by integrating nano-technologies into a device attached to a mobile phone to detect disease markers from exhaled breath. This approach is based on a unique sensor array response to the breath sample, which is recorded, stored and pre-processed via the cell phone. Subsequent to the initial pre-processing, the relevant sensor response signals are conveyed wirelessly via the cellular network to an external server. Statistical pattern recognition methods are then applied on the received data in order to decipher and annotate the array's response. In general, the different statistical programs compare the responsive pattern of the sensor array to previously known samples which have been a-priori fed to the program as a training set. This analysis is then translated to a screening result harboring a level of certainty of the particular breath sample, originating from a ""Sick"" or ""Healthy"" individual. The combination of this breath analysis with additional personal information such as age, weight, etc., leads to the generation of a clinical report which is sent back to the designated receiver (e.g. specialist, family doctor). SNIFFPHONE represents a new concept addressing major societal challenges in health and well-being of the general population. We envision the SNIFFPHONE concept to serve as a novel platform from which more innovative ideas and projects may immerge. In this regard the SNIFFPHONE project has its own sustainable growth prospect.

In addition to pre-screening, the new SNIFFPHONE add-on device shall have the potential to be utilized as an on-going treatment diagnostic tool. The fact that a patient is able to take countless diagnostic measurements at different time points during the day in a practically effortless manner is a great advantage. Moreover, the wealth of data generated by these tests may be automatically processed and analyzed to generate a continues and comprehensive surveillance report to be evaluated periodically by the treating doctor. Indeed, the chain of events described above, may actually convert a person's typical every day privet life environment to a very sophisticated monitoring environment, circumventing the need for long post-treatment hospitalization periods. Besides the research and development as well as clinical units, the SNIFFPHONE project also involves four European SMEs and one big industrial company, thus fostering European multidisciplinary and competitive ecosystems.

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"The major activities of the SNIFFPHONE project revolve around the detailed planning, design and production of the first prototype; it's testing in multiple aspects, conclusion drawing and implementation in the design of the second prototype. Finally the fabrication and initial characterization of the second prototype have been carried out.
Briefly:
• Sensors array fabrication - A large number of synthesis and deposition parameters were manipulated and optimized giving rise to the optimal conditions, for each chemistry. Exposure to various VOC's yielded valuable insights on the variability of sensor-to-sensor as well as on the sensor(s) drift and aging parameters. The array was also exposed to GC markers, and a Matlab code was generated in order to facilitate the selection and calibration of the sensor array.
• NV- Humidity sensors were adjusted, their response time was reduced via addition of a heating body in the second prototype. The fitting of three humidity sensors demonstrated to efficiently detect the beginning of the breath, were complimented by the addition of pressure and proximity sensors as well. This ensured repeatability in the measurement of the exhaled breath and was implemented in the second prototype.
• MFCS manufactured different ""microfluidic chips"" and ""breath inlets"" which were tested by UIBK. The optimal exhalation distance and mode were investigated and a breath collection protocol was devised and implemented in the clinical trials. in addition, an improved microfluidic chip was manufactured and fitted in the second prototype.
• Cellix manufactured a pump for optimal performance. The chamber size was enlarged and two valves were added. In addition, Cellix has manufactured the case and assembled the prototype and contributed to the communication protocol in both prototypes.
• JLM manufactured the PCB boards, firmware and software to communicate and activate all functional parts of both prototypes.
• Breath samples were analyzed by VTT according to statistical methods (LDA and DSI). VTT has also provided a safe ICT platform for data transfer and analysis which would maintain the privacy of the users. In the forth year VTT also validated the accuracy of the classification model in the general public.
• UOL collected heathy valentines and GC patents and generated data from there prototypes. This was accompanied by a study on confining factors generated on the same data base and a consecutive general public study was preformed.
• UIBK and Technion launched a GC marker study on the samples gathered in the clinical trials. Data was analyzed by GC/MS, PTR/MS.
• A market study and a literature review were conducted by SIEMENS and three user based questioners were launched. After the manufacturing of the prototype, Siemens and VTT, have repeated the user based survey and principles were extracted and implemented in the second prototype. This was done in an iterative fashion to insure the human driven design principle. In addition, an exploitation work shop was conducted.
• Finally, a responsible research and innovation (RRI) study and a few filed exercises were performed.

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Existing screening means suffer from a multitude of drawbacks. Some are invasive such as colonoscopy and sigmoidoscopy and hence, pose actual risks of medical complications to the patients screened. Others require special facilities in the form of mammography for example which necessitates health care professionals operating the instruments. These caveats are compounded by the unpleasantness and inconvenience, time and money consumption the screening method imposes on the patient. These are all good reasons for the low number of screening methods implemented today. Despite the above, it is widely agreed that one of the most curtail obstacles in screening programs is that a very limited number of diseases currently have an effective screening approach available, e.g. screening for only four cancer types is currently recommended in the EU. The ideal screening test has high-accuracy, low-cost, non-invasive, easily repeated at specific time intervals, easily operated by a lay-person (i.e. non-technical person) and has no or minimal impact on the daily activities of the subject to be screened. In the SNIFFPHONE project, we tackle these requirements for medical screening by designing, developing, manufacturing, and clinically validating a novel handheld and ultra-miniature tool for a mobile phone.
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