Periodic Reporting for period 2 - RAPID-SEP-AST (Rapid diagnostic for bacterial SEPSIS and AMR urgently needed for ICU patients in COVID-19-like epidemics)
Berichtszeitraum: 2021-08-01 bis 2022-07-31
Resistell proposes a faster alternative to current Antimicrobial Susceptibility Testing (AST) diagnostic in SEPSIS patients. Resistell AST (RAPID-SEP-AST) is based on proprietary nanomotion detection technology that measures nanoscale motion (vibration) caused by living bacteria. In the presence of an effective antibiotic, bacteria die and motion ceases, indicating that the bacterial infection can be treated with that specific antibiotic. RAPID-SEP-AST takes 2-4h to provide diagnostic results, a contrast with the average of 24h that other current market leading AST diagnostics take. This allows RAPID-SEP-AST to guide the treatment of patients with time-sensitive clinical process, such as SEPSIS, which requires the start of antibiotic therapy within three hours of infection. Currently, SEPSIS patients are treated with empirical broad-spectrum therapies that target multiple bacteria due to the lack of rapid AST diagnostics to guide specific treatments. Although lifesaving, this approach causes inadequate treatment in 40% of patients and leads to the development of antimicrobial resistance (AMR), a current global threat.
In the first year of the project Resistell's team have achieved all objectives and managed to optimise the production and packaging processes of the device and disposables. Technology source was further engineered and tested, production process was optimised and the automatic assembly line is now in place. A full technical documentation, manufacturing plan and assembly instructions are now in place. The commercial ready version of the software was designed, developed and tested in pre-clinical setting and also installed and tested in the clinical setup. During the process, a set of user tests took place place allowing confirmation that the software operates as it should and provides the reports needed by the clinical decision makers. The Clinical Protocol for the Performance Evaluation study was developed and accepted by the Ethical Committee. The first clinical study is already ongoing and after the pilot data is available in Q4 2021, the next hospital will join further studies. Thanks to EIC Accelerator project Resistell's team managed to develop additional patentable IP and thanks to a very fast progress in the technology development and validation relations with industrial partners were established.
Resistell has managed to demonstrate a solution, already at the stage of clinical studies, that allows the correct selection of antibiotic treatment on the same day when the patient was diagnosed with blood stream infection or sepsis. This proves a huge impact on treatment decision making for the infected patients. So far, there is no solution on the market, which can provide this information in such short time and with this accuracy, specificity and sensitivity. Resistell AST will have a large impact on the patients' outcomes, reduction of the spreading of AMR and will also generate large savings for the healthcare system by shortening the time in Intensive Care Units and also will save many lives.