Förster rapid resonance microbiosensor (FRET) prototype manufacturing technology for early diagnosis of acute myocardial infarction (AMI)

CardioFRET


Program PN III: Program 2-Increasing the competitiveness of the Romanian economy through research, development and innovation

Subprogram name: Subprogram 2.1 - Competitiveness through research, development and innovation
Project type: Transfer project to the economic operator
Project financed from the state budget and co-financed by DDS Diagnostic
Contract No. 37PTE / 2020
Period: 2020-2022
Coordinator: DDS DIAGNOSTIC S.R.L Bucharest
Project Director: Dr. Dana STAN

The main purpose of the project

Development and development of prototypes of fluorescence detection microbiosensors based on Förster resonance energy transfer (FRET) for fast and sensitive detection of whole blood samples of 4 important cardiac markers in acute myocardial infarction (AMI) using an analyzer with fluorescence detection.

General objectives of the project

O1. Development, manufacture and testing of microbiosensors for the determination with high sensitivity of 4 important cardiac markers in the diagnosis of AMI: hFABP, CK-MB, myoglobin, troponin ITC complex;
O2. Connecting applied research and technological progress in Romania to the evolution and requirements of the national and international socio-economic environment;
O3. Development of partnerships between the research environment and the private environment;
O4. Stimulating the growth of private sector spending on research and development, both for their own activities and for collaboration with research organizations;
O5. Strengthening the innovation capacity of enterprises and consolidating their contribution to the creation of new products (microbiosensors for in vitro diagnostics) / technologies (microbiosensors manufacturing) with the potential for commercial exploitation on the domestic and international market;

Consortium

Coordinator: S.C. DDS Diagnostic S.R.L.
Project manager: Dr. Dana STAN
Partner: National Research and Development Institute for Microtechnology Bucharest (IMT)
Project manager: Dr. Carmen Marinela MIHAILESCU

Expected results:

The final microbiosensor box prototype will be made.
The clinical study will be performed in compliance with the ethical norms in force.
Technology validation and technology transfer to DDS will be performed.
The results will be disseminated through the organization of workshops, participation in specialized conferences and publication of articles in scientific journals.


CardioFRET Project Results

Stage 1 - 2020 - Development of technology for encapsulated microbiosensors and related ink-jet solutions.

In the Stage 1 of the CardioFRET project, the DDS and IMT partners realized:
- design of the experimental model of microbiosensor cassettes with the integration of internal controls and membranes for integral blood separation.
- Elaboration of the technology for realization and printing of bioconjugate solutions / antibody solutions / printable ink-jet blocking solutions and formulas of soluble graphene oxide solutions

Deliverable:
- Technical design report and Technological report for the manufacture of cassette microbiosensors and printable ink-jet solutions.


Dissemination:
- Realization of project website.


Stage 2 - 2021 - Realization, presentation and demonstration of the functionality of the developed microbiosensors Testing of the integrated microsensor system model (hFABP, CK-MB, myoglobin, Troponin I) in the real environment.

In stage 2 of the project, the DDS and IMT partners realized:
- Demonstration of the functionality of microbiosensors in the real environment.
- Experimenting with the integrated system model demonstrating its usefulness on whole control blood samples.
- Development of optimal working methods in the laboratory for the detection (based on FRET) in fluorescence of the cardiac markers Troponin ICT and h FABP using the POC system.

Deliverable::
- Reports demonstrating the functionality of microbiosensors in the real environment;

Dissemination:
- Project website update;
- Flyer of the project presentation;
- Participation in the most important European fair for medical devices: Medica Dusseldorf, Germany.


STAGE 3 - 2022 - Design, realization and verification of the final prototype in the real environment. Manufacturing technology validation. Technology transfer.

In stage 3 of the project, the DDS and IMT partners realized:
-Optimal laboratory methods for fluorescence-based detection (FRET) of cardiac markers Myoglobin and CKMB using the POC system.
-Design, realization and final prototype verification in the real environment. Prototype testing and experimentation using min. 60 patient whole blood samples.
- Technological audit for the experimental development phase.
- Validation of microbiosensor manufacturing technology and technological transfer to the company.

Deliverable::
- Prototype realization. Technology validation report. Technology transfer report.;
- Filing 2 patent applications.

Dissemination:
- Participation in two medical conferences with international participation;
- 1 ISI article under evaluation
- 1 workshop with a specialist in the medical field
- Project website update;