This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 733515

Horizon 2020

Platinum Project

(Part of the European Union’s Horizon 2020 Program)
A

Grant Start Date:

1 August 2016

Grant Amount

Grant Amount:

€2.170 million

Grant Duration:

24 months
Z

Project Aim and Summary

The project aims to develop, prototype, validate and launch a portable assay system for the screening, diagnosis and monitoring of pre-diabetes and diabetes. It consists of a disposable in vitro diagnostics device equipped with a lab-on-a-chip* used for POINT OF NEED testing of glycated hemoglobin (HbA1c). The device relies on cutting-edge diagnostic technology using protein biomarker analysis, which separates and labels target molecules in order to detect and quantify the amount of HbA1c in a drop of blood.

The way this diagnostic device has been conceived and designed makes it genuinely different to other devices available on the market. It consists of a micro-chip embedded in a disposable cartridge, which links to a software application on a smartphone, tablet or computer.
The system is very easy to use and does not require external calibration (device is stable at room temperature both in storage and in use). These standout features, together with its low cost,
will make it a high-value option for the end user (patient self-testing, general practitioners, community pharmacies, hospital staff, etc) to combat the diabetes epidemic worldwide.

 

 

Progress Update

Current business status:

  • HbA1c device showcased for the first time at the 11th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2018) in Vienna, Austria, on 14-17 February 2018 
  • Completed business plan and go-to-market strategy
  • Scouting for commercial partners – discussions with several potential partners (EU and US) in progress
  • Scouting for partners for Round B financing in process

Current prototype status:

  • Methods frozen (Input, Purification, Assay)
  • Chip fabrication processes frozen
  • Chemistry for A1c frozen
  • Characterization in vitro and in vivo with A1c successful
  • Design of the final device and software application in process
  • Clinical trials approved by the San Raffaele Hospital (Milan, Italy) ethical committee and ready to start
  • Manual and automated back-end process ongoing with new selected partners

Current algorithm status:

  • Procedure frozen
  • Optimization successful by hand
  • Automatized algorithm being tested

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*Products/devices are under development but not yet approved for use. For investigational use only.