Periodic Reporting for period 1 - FIT-BI (Fully Integrated Technology for rapid and multiplex Bacterial Identification)
Reporting period: 2023-06-12 to 2025-06-11
Invasive neonatal infections constitute a major global public health challenge claiming 6 deaths per 1000 births and with neonates acquiring pathogens either in utero or during the delivery period being the critical time for. Neonatal bacterial infections primarily acquired at the time of delivery through maternal-fetal transmission, remain a leading preventable cause of mortality and morbidity. The bacteria most involved in early-onset neonatal sepsis of term and preterm infants are Group B streptococcus (GBS) and Escherichia coli, with around 70% of infections followed by other bacteria such as Staphylococcus aureus colonizing the maternal genitourinary tract and contaminating the amniotic fluid.
Despite the progresses made in the reduction of morbidity and mortality from neonatal sepsis, diagnostics still relies primarily on conventional microbiology techniques with the gold standard for establishing a diagnostic of neonatal sepsis still being through culture which is time-consuming and can be inaccurate. In the particular case of MFI risk screening, the duration of the test is an essential parameter that strongly impacts its clinical utility. In fact, the time between performing the vaginal sample and determining resistance to antibiotics by culture techniques, 2 to 3 days in clinical practice, is a major obstacle to defining the appropriate prescription by the clinician. Diagnostics with a faster turnaround time would likely improve surveillance in all settings but also enable timely management of infections
The aim of this project was to design an innovative microfluidics-based diagnostic tool to identify a subset of key bacteria and associated resistance genes within a rapid turnaround time, and at the point-of-need. The novelty of the project relies on the use of an old method of molecular colony (also known as polony) amplification coupled with smart polymer and multiplex-qPCR to detect bacteria and determine antimicrobial susceptibility; thus, the success of the project depends on the experimental design.
Despite the progresses made in the reduction of morbidity and mortality from neonatal sepsis, diagnostics still relies primarily on conventional microbiology techniques with the gold standard for establishing a diagnostic of neonatal sepsis still being through culture which is time-consuming and can be inaccurate. In the particular case of MFI risk screening, the duration of the test is an essential parameter that strongly impacts its clinical utility. In fact, the time between performing the vaginal sample and determining resistance to antibiotics by culture techniques, 2 to 3 days in clinical practice, is a major obstacle to defining the appropriate prescription by the clinician. Diagnostics with a faster turnaround time would likely improve surveillance in all settings but also enable timely management of infections
The aim of this project was to design an innovative microfluidics-based diagnostic tool to identify a subset of key bacteria and associated resistance genes within a rapid turnaround time, and at the point-of-need. The novelty of the project relies on the use of an old method of molecular colony (also known as polony) amplification coupled with smart polymer and multiplex-qPCR to detect bacteria and determine antimicrobial susceptibility; thus, the success of the project depends on the experimental design.
The FIT-BI project has achieved a noteworthy advancement in its molecular petri dish (MPD) technology, by successfully elevating its Technology Readiness Levels (TRLs) from the foundational stage of TRL 2 to the more advanced level of TRL 5. This substantial progression signifies a critical step toward real-world application and market availability. By using molecular colony assays with several key technologies, multiplexing capabilities was enhanced with preliminary results showing that up to nine species can potentially be distinguished within 30 minutes from samples to results.
The key exploitable result generated by the FIT-BI project is the multiplex microbial detection approach, which has provided the fundamental basis for a patent application. This novel approach allows for the simultaneous detection of multiple microorganisms, offering significant advantages over traditional single-target detection methods. The patent application seeks to protect the intellectual property associated with this innovative technology developed within the FIT-BI project. Potential exploitation pathways could include licensing the technology to diagnostic companies, developing and marketing diagnostic kits based on the approach, or integrating the technology into existing or new diagnostic platforms. Further elaboration on the specific advantages of this multiplex detection approach, the scope of the patent application, and potential market applications would be beneficial for a comprehensive understanding of its exploitation potential.