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Portable Diagnostic Medical Device Based on Lab-on-Chip for Detection of Protein Biomarkers of Medical Interest.

Periodic Reporting for period 3 - PLATINUM (Portable Diagnostic Medical Device Based on Lab-on-Chip for Detection of Protein Biomarkers of Medical Interest.)

Reporting period: 2017-12-01 to 2019-01-31

The project aims at developing, prototyping, validating and bringing to market a portable assay system for the pre-diabetes and diabetes diagnosis and control, consisting of a disposable medical device equipped with a Lab-on-Chip (LoC) used for Point of Need or Self-Monitoring of protein biomarkers in biological fluids, like Glycated Hemoglobin (A1c).
The medical device relies on a unique technology for diagnosis via protein biomarkers analysis, comprising a separation and a labelling stage of target molecule to detect and quantify the amount of glycated Hemoglobin in a drop of blood.
The way this diagnostic medical device has been conceived and designed makes it unique compared to other devices available in the market. It is based on a disposable chip, easy to use, which does not require qualified personnel assistance and manipulation of the sample. Stable at room temperature both in storage and during use, it does not need external calibration. These characteristics, together with its low cost, make it an excellent option for the final user (patient, pharmacy, hospital, etc.).
The proposed diagnostic medical device consists of a LoC based on breakthrough microelectromechanical systems for protein detection through the protein biomarkers analysis. Such medical device is cheaper (€2-3/device), faster (~10 minutes), more robust (to vibrations, to high/low temperatures), more durable (2 years ambient-stored) and more versatile (easy to use, software-programmable, smart-phone, pc or tablet integrated - available for any mobile operating system) than the already available and the foreseen portable alternatives, while being as precise as the costlier laboratory solutions.
The project is relevant to the selected work programme because it regards an innovative medical device for diabetes and pre-diabetes, thus with diagnostic and prevention applications, based on a solid feasibility study and a business plan. The project intends to bring the medical device from TRL7 to market.
From the beginning of the project the following goals have been reached

- An original electrochemical detection technique has been developed for A1c based on molecule tagging with Ferrocene Boronic Acid Square Wave Voltammetry;
- Three prototypes generations of the Lab-on-Chip that is the core of the device have been realized for a total of more than 150 chips using mass production MEMs technologies;
- About 20 chips of the last generation have been tested with blood of patients with different health conditions and the results compared with laboratory results. The correspondence between results have been well within the limits of the clinical protocol for the measure of A1c;
- Preliminary robustness tests have been performed both using thermal cycles and pressure variations. The chip robustness has been confirmed by these tests;
- New prototypes to be realized in Silex AB has been designed in March 2017 and the first chips were delivered in June 2017. Dimension and general design, bonding polymer and electrophoretic characteristic are optimized to improve physical and chemical properties, performance and increase the LoC resistance during room temperature;
- Final design of the external package of the LoC has been carried out and a mockup has been realized;
- The clinical trials with San Raffaele Hospital has been approved from the ethical committee and started in February 2018. After an initial set of calibration tests has been interrupted to modify the Hb testing methodology in order to guarantee an higher sensitivity level. After redesigning the Hb measurement methodology a new set of calibration tests has been executed and more than 120 tests have been carried out to set the calibration curve unsuccessfully, because of the lower efficiency of the micro-electrophoresis system. Thus the trial has been again interrupted.
- A new Prototype design process has been launched to solve the encountered issues and constraints. Two different configurations of Electrophoresis prototypes have been developed, one concentric paper based configuration to increase the target proteins concentration and one liquid based to avoid the contribution of wet matrix material
- A new Electro-chemisty system has been identified and under prototype phase by using a different methodology to target Hb and HbA1c, by using specific Aptamers to be attached to the gold electrodes in order to highly increase specificity and sensitivity.

- A B2B business model has been decided so to position Dianax as a device supplier;
- A detailed market study has been carried out studying the single application cases of a portable A1c test to confirm the business plan hypothesis;
- A more detailed strategy to Go to Market has been analysed and identified targeting different market channels for A1c;
- Calculation of the real impact of a portable A1c measurement system on the diabetes market;
- Several activities have been conducted to identify the best potential partners in the various market segments, including participation to specific events where investors and various stakeholders took part.

Different dissemination initiatives have been carried out like:
- International press releases in correspondence to the main events related to the company;
- Papers in newspapers (like “Il Sole 24 Ore”) and specialized journals (Like “Le Scienze”);
- New WebSite, optimization of the Dianax LinkedIn webpage and starting of the Dianax twitter page;
- Participation to several dissemination meetings with interested stakeholders.
No portable system exists to measure A1c with laboratory like precision. Applications of such a device can transform the way diabetes is prevented and monitored by
- Allowing fast diagnosis at the Point of Care (e.g. the base care physician or the pharmacy) of pre-diabetes;
- Allowing a pre-diabetes patient to monitor the effects of her efforts to comply with lifestyle indications and maximizing the probability to prevent diabetes;
- Allowing diagnosis of still undiagnosed diabetes at the Point of Care (e.g. the base care physician or the pharmacy) so decreasing the burden due to undiagnosed diabetes;
- Allowing monitoring of diabetes in patients using oral therapy (e.g. metformin) so to delay or even eliminate the need of a substitution therapy (insulin);
- Allowing easy monitoring of therapy compliance in babies affected by Type I diabetes;
- Allowing diagnosis of diabetes in emergency situations where emergency surgery is required to decide if diabetes compliant anesthesia is required.
Conceptual structure of the disposable unit