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

Projektinformationen

ACU-SERS

ID Finanzhilfevereinbarung: 101158666

DOI

10.3030/101158666

EK-Unterschriftsdatum 5 März 2024

Startdatum 1 Mai 2024

Enddatum 30 April 2027

Finanziert unter

• The European Innovation Council (EIC)

Gesamtkosten

€ 2 499 997,50

EU-Beitrag

€ 2 499 997,50

Koordiniert durch

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)

Berichtszeitraum: 2024-05-01 bis 2025-04-30

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

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

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

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.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

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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