AUTOMATED CLINICAL PLATFORM FOR PERSONALIZED ANTIBIOTHERAPY IN CRITICAL UNITS BASED ON SURFACE ENHANCEMENT RAMAN SPECTROSCOPY

Project Information

ACU-SERS

Grant agreement ID: 101158666

DOI

10.3030/101158666

EC signature date 5 March 2024

Start date 1 May 2024

End date 30 April 2027

Funded under

• The European Innovation Council (EIC)

Total cost

€ 2 499 997,50

EU contribution

€ 2 499 997,50

Coordinated by

DANMARKS TEKNISKE UNIVERSITET
Denmark

Periodic Reporting for period 1 - ACU-SERS (AUTOMATED CLINICAL PLATFORM FOR PERSONALIZED ANTIBIOTHERAPY IN CRITICALUNITS BASED ON SURFACE ENHANCEMENT RAMAN SPECTROSCOPY)

Reporting period: 2024-05-01 to 2025-04-30

Summary of the context and overall objectives of the project

The ACU-SERS project is focused on the development of a cutting-edge point-of-care (PoC) medical device for monitoring antibiotics in patient blood. The project addresses a critical need in clinical settings, particularly in intensive care units (ICU), for real-time, accurate, and accessible drug level quantification, which are essential for optimizing patient treatments, reducing adverse effects, and improving healthcare efficiency.

At the core of the technology is the use of label-free Surface-Enhanced Raman Scattering (SERS) sensors, which enable sensitive and reproducible detection of a broad range of antibiotics using the same sensor platform. This eliminates the need for labeling reagents or drug-specific modifications, offering a flexible and scalable approach to therapeutic drug monitoring (TDM).

The primary objective of this project is to develop an automated PoC in vitro diagnostic (IVD) device that consists of a microfluidics cartridge with integrated sample pretreatment and SERS sensors, coupled with a compact reader device to deliver rapid and reliable antibiotic drug concentration analysis. The project aims to enable seamless integration into hospitals, ICUs, and decentralized healthcare settings to improve TDM at the bedside.

The expected impact includes:

Speed up analysis and improve precision in antibiotic monitoring, leading to improved patient outcomes.

A more efficient clinical workflow, reducing delays and resource burdens.

A foundation for commercializing an innovative PoC diagnostic tool, supporting the transition of the project into a startup.

You can find more information at our website acusers.eu

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

During the reporting period, the project has made significant strides in both technological development and validation. The main key activities and accomplishments include:

- SERS Sensor optimization: Improvements achieved in the design and fabrication of label-free SERS sensors, focusing on enhancing signal sensitivity, uniformity, and preparation (or making possible) for scaling up production

- Assay Development for Meropenem: Development of a full assay for meropenem quantification in the PoC device, with instrumental and clinical validation.

-System Integration: Optimization of the sample pretreatment and drug separation workflow and integration of processes to semi-automated cartridges.

-Pre-commercial Planning: Establishment of a strategic roadmap for clinical adoption and future market entry.

These achievements mark crucial steps toward the realization of a functional and commercially viable PoC diagnostic solution.

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)

The project aims to surpass current TDM methods in clinics by offering:

Faster and More Precise Antibiotic Monitoring: Unlike centralized laboratory analytical analysis, which can take hours to days, our device provides real-time results at the point of care.

Improved Sensitivity and Reproducibility: Utilizing novel sensor materials and cutting-edge technology to improve drug detection sensitivity and accuracy.

Compact, Automated and User-Friendly Operational device: Reducing the need for highly trained personnel, shortening the time-to-results, and making it suitable for easy to operate at the bedside and outpatient applications.

To ensure maturation and acceptance of technology, additional research, clinical trials, usability, regulatory approvals, and commercialization strategies are being explored.

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