Bacterial Eavesdropping for Fast Antibiotic Susceptibility Testing

Informations projet

BE FAST

N° de convention de subvention: 101136371

DOI

10.3030/101136371

Date de signature de la CE 2 Octobre 2023

Date de début 1 Novembre 2023

Date de fin 31 Octobre 2026

Financé au titre de

• The European Innovation Council (EIC)

Coût total

€ 2 499 143,75

Contribution de l’UE

€ 2 499 143,75

Coordonné par

SOUNDCELL B.V.
Netherlands

Periodic Reporting for period 1 - BE FAST (Bacterial Eavesdropping for Fast Antibiotic Susceptibility Testing)

Période du rapport: 2023-11-01 au 2024-10-31

Résumé du contexte et des objectifs généraux du projet

SoundCell aims at delivering a breakthrough solution for combating antimicrobial resistance (AMR) which is the ability of micro-organisms to become resistant to antibiotics. By various estimates, AMR is conceived as one of the biggest threats that the global community will be facing in the near future. It leads to prolonged hospitalization, increased morbidity, and mortality. AMR is expected to cause 10 million deaths anually by 2050. To fight AMR, the Organization for Economic Cooperation and Development (OECD) has endorsed 3 strategies:
• Promoting more prudent use of antibiotics and reducing over-prescription,
• Enhancing hygiene in healthcare systems,
• Developing rapid antibiotic susceptibility testing (AST) solutions.
Among these strategies, AST plays a crucial role in treating infectious diseases and in the global antibiotic stewardship.

At SoundCell, a TU Delft spinoff, we develop a rapid antibiotic susceptibility testing (AST) platform that allows hospital microbiology labs to determine which antibiotic works within just one hour. Quicker AST results allows hospital physicians to switch from broad-spectrum to narrow-spectrum antibiotics earlier. This results in i) more prudent use of antibiotics, which is essential in combatting antimicrobial resistance, ii) patients receive effective antibiotics sooner, which can mean the difference between life and death in acute infections like sepsis.The key of our technological breakthrough lies in the concept of leveraging bacterial nanomotion to assess antibiotic susceptibility. This approach does not depend on bacterial growth rates, which is the limiting factor for currently used systems that take two days to provide results.

With the EICT project BE FAST, SoundCell team aims at building high-volume manufacturing methods, enhancing the throughput of its graphene AST platform, and validating it against clinicals strains of bacterial cells. During the project, we will mature our commercial strategy, perform market studies and establish our regulatory roadmap. We will also place our first prototypes in hospitals to benchmark the sensitivity and speed of our platform against available AST platforms. With fast determination of antimicrobial resistance, we envision that BE FAST will have direct impact on health-care system, as it will improve treatment outcomes, save lives, and reduce hospital stays.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

Our work consisted of developing a measurement device and the consumable cartridges. Furthermore we worked on further validation of the technology with clinical samples and outlining the regulatory pathway for CE/IVD certification. We performed various task in parallel, to allow placement of the readout machines in the hospital in 2025 with sufficient supply of consumables containing our graphene chip technology.

We have now three devices working and are performing validation studies internally to fix the last bugs before placement in a hospital laboratory. The measurement platform is a standalone tabletop machine that reads out the consumable cartridges and communicates the results (antibiogram) with the hospital electronic patient records/system. The measurment devices are a one-off purchase for microbiology labs and replace competitor solutions in the testing workflow. Based on daily testing throughput, multiple devices may be required. Per patient sample, one consumable cartridge is prepared by the lab technician and placed in the measurement device. Sample preparation follows the current lab workflow. The device offers random access, meaning additional cartridges can be placed in the device while earlier tests are running. After completion of the test, the cartrdige is disposed, since cartridges contain the harmfull microorganisms causing the infection.

We developed microfluidic cartridges in which that can easily be filled by a laboratory technician for usage in a clinical setting. We developed a pilot assembly procedure for the consumables that contain graphene chips with pre-deposited antibiotics. With the current standard operating procedures, we run up to 25 cartridges / week production that is sufficient to supply the three devices with consumables. We can now manufacture etched wafers, transfer grahene, and singulate the chips in wafer scale.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

Our R&D strategy focuses on creating a gold-standard AST solution by addressing key customer value drivers: speed (1-hour antibiograms), ease of use, cost efficiency, and reliability. We aim for a scalable, high-throughput AST platform, combining advanced graphene sensors and automated systems, targeting market readiness by 2027. We have conducted customer and expert interviews, we defined the following value drivers:

Within BEFAST so far, we have build a prototype of our AST platform, the MelodyOne, that currently runs cartridges hosting 7 graphene chips each. We are performing trials internally and secured collaboration with clinical hospitals who will test the devices starting coming January in parallel to their current workflow. Furthermore, we have clarified our certification (CE/IVD) and industrialisation plan for the coming two years. We have had initial meetings with Notified Bodies and are ready to select the most suitable one for assessing our technical file. Furthermore, we have defined our industrialisation path and secured strong partnerships, that will be further supported through a Eurostars porgramme. Finally, we have a clear picture of the Dutch market landscape and we are further expanding our network, and recently had our first introductions with potential partners in Germany and Belgium to further clarify their specific commercial needs.

Our technical roadmap is designed so that we can produce and provide our first commercial AST solution to our customers, based on the above value specifications, in an efficient and scalable manner by 2027. In short, we need to scale up our AST platform such that we can test up to 9 antibiotics, at different concentrations, in cartridges where each cartridge hosts up to 28 graphene sensor chips. This will make our AST capabilities faster by a factor ~100 compared to our initial proof-of-concept prototype. It also allows us to move from a single antibiotic screening on a chip to a full antibiogram determination, thus enabling us to already fulfil market needs for urgent AST cases such as sepsis.

MelodyOne - Rapid Diagnostics by SoundCell