Diagnostics device for rapid identification and antibiotics susceptibility testing of pathogens

Project Information

Biotrack-MED

Grant agreement ID: 875784

DOI

10.3030/875784

Project closed

EC signature date 21 July 2019

Start date 1 August 2019

End date 30 November 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

BIOTRACK BV
Netherlands

Periodic Reporting for period 1 - Biotrack-MED (Diagnostics device for rapid identification and antibiotics susceptibility testing of pathogens)

Reporting period: 2019-08-01 to 2019-11-30

Summary of the context and overall objectives of the project

Our company is working on a solution to provide fast and accurate identification of pathogen microorganisms with a revolutionary device, Biotrack®, to allow clinicians to effectively manage patients infections at the point-of-care.
Most commonly used test combine cell culturing and microscopy analysis. However, only 5-10% of microorganisms are culturable, and they usually take 2-4 days but can be as long as 9 days. As clinicians wait for a result they prescribe broad-spectrum antibiotics. This unspecific management of infections results in antibiotic microorganisms resistance increase (AMR), and failure of therapy with a high impact on hospital cost, the length of hospital stay, and mortality and morbidity. This impact is particularly significant in surgical practices, which count for 25% of all hospital AMR.
We aim to improve our prototype to offer an instrument for pathogen detection in operating rooms: easy to use, autonomous functioning, with high sensitivity and accuracy and cost-effective.

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

We evaluated the technical tasks, and clinical studies we need to perform to achieve TRL8.
To offer a competitive diagnostic device we will optimize our prototype in design, performance and cost. We identified all the services that we need to outsource, and the best potential suppliers for the equipment and the material we need.
The clinical studies so far validate the potential of our device for to detect Antimicrobial resistance (AMR) dose-response, to identify Metilicine resistant Staphylococcus arueus (MRSA), Q-fever bacterium (Coxiella burnetti), different species in human gut flora, to test on sterility and MRSA infections of endoscopy and dental equipment, and to monitor of dialysis fluids and dialysis instruments. Through this project, we have designed four additional clinical studies to evaluate the performance of Biotrack® for sterility testing for orthopaedic surgery, AMR, Lyme's disease and MRSA. These studies will strengthen the claims of our value proposition.
We have calculated that we need €3,8 Mn to carry out these activities, 70% of it will be covered by the EU and the 30% from by our mother company, Dutch Water Technologies BV (DWT).
We aim to commercialize Biotrack® after Accelerator project in Europe and the USA. To ensure that we will be able to do it we have studied the clinical care market within these regions and got informed of the European and USA laws we will need to comply with. These activities will be covered by (DWT).

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 lack of information on patient infectious pathogens drives to inappropriate antibiotic treatments to 30% of them, with a high impact on AMR, which increases hospital budget by 1,6. The main driver is the length of stay and thus, reducing it is crucial to reduce expenses.
Our company has invented a method to detect microorganisms in fluid samples at point-of-care using DNA probes with fluorescence label for each targeted pathogen. It will allow identifying the microorganism causing the disease in a fast way, to prescribe the appropriate treatment, and to monitor the effect of the antibiotic used. As a consequence the length of hospital stay will decrease, the survival rate will increase and the morbidity will be reduced.
This innovation will have a high impact on our company. In five years after product development, we expect to sell 295 devices which will bring an accumulative profit of 41,2 Mn, a ROI of 3,8, and will allow us to hire 15 new employees.

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