Versatile Amplification Method for Single-Molecule Detection in Liquid Biopsy

Project Information

VerSiLiB

Grant agreement ID: 101046217

DOI

10.3030/101046217

Project closed

EC signature date 21 March 2022

Start date 1 April 2022

End date 31 March 2026

Funded under

• The European Innovation Council (EIC)

Total cost

€ 2 994 244,99

EU contribution

€ 2 994 244,99

Coordinated by

TEKNOLOGIAN TUTKIMUSKESKUS VTT OY
Finland

Periodic Reporting for period 3 - VerSiLiB (Versatile Amplification Method for Single-Molecule Detection in Liquid Biopsy)

Reporting period: 2024-10-01 to 2026-03-31

Summary of the context and overall objectives of the project

Project has develop a proof-of-concept of a novel in-vitro diagnostic system that enables analysis of DNA and protein biomarkers using one proteogenomic test platform. Project is the first step to enable easy-to-use proteogenomic tests having potential to be widely utilised in the diagnostics of several significant diseases including viral outbreaks, cancers, neuro-degenerative, immune and cardiovascular diseases. In the end of the project, the developed technology was tested for cancer management in a clinical scenario.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Work during the the project has focused on:
• Defining system specifications
• Development of the sensor test chemistry for protein and DNA assay
• Design and implementation of the microfluidic chip for digital readout
• Design and development of the integrated hardware prototype
• Conducting simulations and theoretical analyses
• Development of reference tests and standards of truths
• Collection of clinical samples
• Testing the developed system in the clinical scenario
The proof-of-concept of the sensing system was successfully developed and tested.

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)

Work to develop diagnostic system based on the Affinity Mediated Transport amplification method has been successfully completed in close collaboration of the highly multi-disciplinary consortium combining expertise in molecular biology, chemistry, physical sciences, engineering, and medicine. In the project, the consortium has developed solutions to the proteogenomic test chemistry and hardware implementation. Consortium sees that the developed system has potential to impact widely to the proteogenomic analyses in medical but also in other application fields utilising molecular analysis.

In overview, the project has developed following results:
*Proteogenomic assay chemistry based on the Affinity Mediated Transport assay principle
*Microfluidic chip for digital detection
*Sensing system hardware, software, user interfaces and signal analysis tools
*Patient samples collected in a registered clinical study (National Library of Medicine (www.clinicaltrials.gov) with the number NCT05940311)