Community Research and Development Information Service - CORDIS

H2020

SNIFFPHONE Report Summary

Project ID: 644031
Funded under: H2020-EU.2.1.1.1.

Periodic Reporting for period 2 - SNIFFPHONE (Smart Phone for Disease Detection from Exhaled Breath)

Reporting period: 2016-02-15 to 2017-02-14

Summary of the context and overall objectives of the project

"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."

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 main activity of the first two years of SNIFFPHONE was the detailed planning, design and production of the first prototype. The first 24 months of the project evolved according to the plan. 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. In addition a Matlab code was generated in order to facilitate the selection and calibration of the sensor array.
• Humidity sensors were adjusted and their response time was dramatically reduced. The fitting of three humidity sensors instead of one was decided up on. The optimized humidity sensors were demonstrated to efficiently detect the beginning and end of the breath. This will ensure repeatability in the measurement of the exhaled breath.
• MFCS designed and manufactured two different ""microfluidic chips"" and three different ""breath inlets"". After an inclusive examination one chip was decided up on. and the analysis conducted by UIBK reviled that the inlets don't really improve the purity of the sample. In addition, the optimal exhalation distance and mode was investigated and an initial breath collection protocol was devised.
• Cellix designed and manufactured a connector to a typical lab monitoring system as well as three different vacuum pumps which were examined for optimal performance. All of the above parameters were met well beyond expectation, which enabled to relax a few constraints of the preliminary planning. The chamber size was enlarged and two solenoid activated valves isolating the chamber were added. Finally, Cellix has manufactured the case and assembled the prototype.
• JLM has designed and manufactured the PCB boards for the functional activation of the SNIFFPHNE prototype. The firmware and software generated by JLM was demonstrated to communicate and activate all functional parts of the prototype.
• Breath samples of healthy volunteers and gastric cancer patients were analyzed by VTT and TECH according to two slightly different statistical methods (LDA and DSI). Similar accuracy levels were reported in both cases. VTT has also provided a safe ICT platform for data transfer and analysis which would maintain the privacy of the users.
• A market study and a literature review of existing and competing devices and technologies, to that developed in the SNIFFPHONE, were conducted by SIEMENS.

• Three different questioners were lunched to better understand the end user and practitioner's perspective of this new product. The first study addressed the views and needs of the lay person. The second questionnaire was tailored to the expert physicians and the third questioner was a web based survey that approached almost 900 doctors worldwide. This study was conducted by the UoL.
• Finally a responsible research and innovation (RRI) study and a few filed exercises were performed."

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)

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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