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 1 - SNIFFPHONE (Smart Phone for Disease Detection from Exhaled Breath)

Reporting period: 2015-02-15 to 2016-02-14

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 heterogeneous micro- and nano-technologies into an autonomous smart system that can be attached to a mobile phone and detect disease markers from exhaled breath. This approach revolves around the interaction between breath sample and a miniaturized array of highly sensitive nanomaterial-based chemical sensors. This interaction leads to a unique sensor's response to the particular breath sample which is recorded, stored and pre-processed by an integrated miniature cell phone add on device. This device is made by incorporation of intricate microfluidics, electronics and sensor on-chip nanoarray. Subsequent to the initial pre-processing, the relevant sensor responsive resistance 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. In other words, the supervised pattern recognition algorithm, is determining the level of similarity of a certain responsive pattern to either "Sick" or "Healthy" known patterns. 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) when a positive result is revealed. SNIFFPHONE represents a new concept addressing major societal challenges in health and well-being of the general population, while taking into account constituent ethical and security aspects. The SNIFFPHONE add-on end-product shall integrate functionalities that are relevant to the health screening applications. We aim to target the final product to have a decreased size dimension of approximately 30-40 folds over existing pre- screening devices. Moreover, the final end product of the sniffphone device shall 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. Extrapolating in the sniffphone increased predictive and cognitive functions it is easy to envision additional and complimentary applications which may be added on to that same platform.
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. Utilizing a breath based diagnostic tool as convenient and as practical as sniffphone, prove to be the perfect mean for a treatment follow up assessment. That fact that a patient is able to take countless diagnostic measurements at different time points during that 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 establishing and fostering European competitive ecosystems for the design and commercialization of innovative miniaturized smart systems. This novel innovative project is a manifestation of a multi-disciplinary effort emanating from very different capabilities and it partners bring in very diverse backgrounds."

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 focus of the first year of SNIFFPHONE was the planning and production of the core basis of the add-on device that would enable, at later stages, the diagnosis and screening of gastric cancer via the smartphone. This prototype shall contain a sensors array that are integrated within a microfluidic chamber and connected with a micro-pump to enable the flow of exhaled breath over the sensors array. The first 12 months of the project evolved according to the plan with one deviation, which is the delay in deliverable D2.1, due to a hardware problem that was solved. The elaborated course of work that was carried out is detailed in part B. Briefly:
• Sensors array based on molecularly-modified gold nanoparticles was fabricated and optimized by the TECH partner. A very large number of synthesis and deposition parameters were manipulated and optimized. Electrodes have been miniaturized and on-chip array was planned, manufactured and characterized. Exposure to various VOC's yielded valuable insights on the variability from sensor-to-sensor as well as on the sensor(s) drift.
• Humidity sensors were manufactured and optimized by NV to indicate the exact time in which the exhaled breathe, to be measured, starts. This was termed "T0". The precise identification of "T0" is important since it allows the imbedded software to activate the pump (see below) and the valves in a synchronized manner, thus ensuring repeatability in the measurement mode in time, relative to the beginning of the exhalation. The newly-fabricated humidity sensor was identified with high resolution (response of milliseconds).
• Two different "chip holding device" as well as three different "breath inlets" were designed and manufactured by ChipShop. The purpose of these holders is to enable the assembly the different parts together and allows efficient breath collection and examination. These holders were made with slight variations in their microfoidic channeling architecture and in the material from which they were constructed. All of the five variations were tested with artificial breath for interaction of the material with different gases. In addition, the different inlets were compared with environmental air from different exhalation distances. The optimal design was achieved according to the preferences of healthy volunteers, after they have tried all of the aforementioned designs.
• The humidity sensors as well as the sensors array were designed to be functionally integrated via a connector PCB board. A number of pieces of this board were fabricated by Cellix along with a connector to a typical lab monitoring system. This was done in order to allow for the different lab tests to be carried out on the on-chip array, which will serve as the final sensor host.
• Three different vacuum pumps were designed, fabricated and tested for optimal and cost-effective suction capacity and activation time by Cellix, in order to manufacture a pump which would be suitable for the SNIFFPHONE task. Both suction capacity and activation reached figures well beyond expectation (suction capacity of approximately 1ml/min and activation time of milliseconds). These figures relax few constraints, which were pivotal in the preliminary planning. The chamber size and the microfluidics that lead to it, for example, can be enlarged from 10 µl up to 100 µl since the flashing of the sample can easily reach 5 chamber volumes with in one second.
• Two solenoid activated valves have been identified and characterized, in order to isolate the sensor chamber from the outside environment as well as to allow for stable conditions during time duration of a few seconds for the sensors to equilibrate with the breath sample. Currently these valves are being analyzed for their activation time, hermetic seal and gas inertness.

In parallel to the development of the hardware of the SNIFFPHONE, clinical-related surveys and analysis, to better understand the exact need of the SNIFFPHONE concept were carried out, as indicated below:
• Breath samples of volunteers with gastric cancer and control health conditions were analyzed by the TECH partner by the differential factor analysis (DFA) statistical method and re-analyzed, independently, by VTT partner using a slightly different statistical model linear discriminant analysis (LDA). Similar accuracy levels were reported in both cases. VTT also generated a disease state index (DSI) which combines sensor data (LDA) with personal background data. In addition, VTT has 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. This study was conducted by VTT and included the explicit opinion of different focus groups on the "pros and cons" of using the SNIFFPHONE. The second questionnaire was tailored to the expert physicians. This study was conducted by SIEMENS and similar to the firs one it was based on opened questions in which the export physicians could state their views with regard to the need and mode of use of this novel device. The third questioner was a web based survey that approached almost 900 doctors and researchers worldwide. This study was conducted by the UoL partner and was naturally constricted of multiple choice questions. The aim of the web based survey was to practically monitor the opinion of a large audience and derive general market trends and principals from it. The results of this comprehensive study are summarized in WP7.
• Finally a responsible research and innovation (RRI) study and 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. Moreover, this device is intended to facilitate repetitive and almost continuous monitoring of exhaled breath at different time points in the course of the person’s and/or patients daily life. The sniffphone system is designed to be characterized by low-cost, low-energy consumption and be ultra-miniaturized. This add-on device will serve as a breath test tool that is attached to a mobile phone, compatible with most common mobile platforms (e.g. Android, iOS), and is fully powered by the cell-phone battery. Likewise, it is designed to display multi-functional properties, including sensing, storing, processing, actuation and ultra-wideband communication. The proposed system has several advantages over the existing technologies: 1) monitoring health by breath analysis can be performed outside a specialized environmental settings without the need for any technical expertise; 2) the SNIFFPHONE is simple and inexpensive enough to manufacture at industrial scale; 3) operation of the device will be simple, and the results would be interpreted swiftly and automatically by the integrated software; and 4) the SNIFFPHONE platform can be used as a launch pad for further innovative initiatives to achieve rapid monitoring for other diseases using breath samples.

Related information

Record Number: 190094 / Last updated on: 2016-11-07
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