Next generation Sepsis pathogen diagnostics: Revolutionary device for rapid detection of Sepsis

Project Information

SepTec

Grant agreement ID: 967968

DOI

10.3030/967968

Project closed

EC signature date 17 March 2021

Start date 1 April 2021

End date 31 December 2023

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 455 250,00

EU contribution

€ 2 418 675,00

Coordinated by

NOVUS DIAGNOSTICS LIMITED
Ireland

Periodic Reporting for period 2 - SepTec (Next generation Sepsis pathogen diagnostics: Revolutionary device for rapid detection of Sepsis)

Reporting period: 2022-04-01 to 2023-12-31

Summary of the context and overall objectives of the project

Novus Diagnostics aims to drive infection diagnosis directly to the patient’s bedside where it is needed. Novus’s In-vitro diagnostic system, SepTec, has three components; a patent-pending disposable cartridge, a blood loading tool to automate blood transfer into the cartridge, and an automated bedside analyser that screens whole blood for Sepsis-causing bacteria detection within 15 minutes without the need for time-intensive, complex lab testing.
Sepsis is a life-threatening complication that arises from bacterial, viral or fungal infection whereby the body can ultimately shut down in a bid to fight off said infection. If not recognized early and managed promptly, it can lead to septic shock, multiple organ failure and death within hours. Time is critical, for every hour Sepsis goes undiagnosed/mistreated, a patient’s chances of survival decrease by ~8%. Annually, Sepsis affects 49m people with 11m deaths, accounting for 1 in 5 deaths worldwide. Combined, Sepsis treatment costs the US and EU healthcare systems ~$68bn annually making it the costliest healthcare condition to treat.
Current bacterial diagnostic approaches are multi-stage complex processes that take 1-3 days to provide results and require skilled personnel and laboratories. Thus, there is an urgent need for a rapid, accurate and simple method to identify Sepsis, and inform on the source of infection, directly at the patients’ bedside, allowing clinicians to administer appropriate treatment in a timely fashion.
The objective of the EIC accelerator fund is to shift the SepTec innovation from TRL6-TRL8, developing and commercializing a regulatory compliant, compact, bedside diagnostic instrument and microfluidic cartridge test system capable of, rapidly detecting and differentiating gram positive, gram negative and fungal bacteria directly from suspected blood-stream infection/Sepsis patients’ whole blood within 15 minutes.

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

The activities performed to meet the specific project objectives 1-9 are given below along with key results achieved to date.

Objective 1 - Hires: Successfully expanded the team from 3 to 16 employees (8 PhDs), including key positions such as CEO, Director of product development, and various engineers and scientists.
Objective 2 – Analyser Development: Developed an advanced analyser system with improved precision, flexibility, and efficiency through a comprehensive prototype build and iterative enhancements based on user feedback and engagement with hospitals.
Objective 3 – Software Development – Automated Diagnostic Result: Successfully developed, trained, and optimized diagnostic software with AI-driven automation, resulting in a laboratory-validated diagnostic algorithm.
Objective 4 - Impedance Reader Development: Designed and validated a bespoke impedance reader with regulatory compliance, multiplexing capabilities, and a user-friendly interface, achieving a functioning SepTec cartridge-compatible impedance reader.
Objective 5 - Blood Loading Tool Development: Developed a blood loader with informed design, automated functionalities, and successful usability and functionality testing with clinicians and healthcare workers.
Objective 6 – Cartridge Design and Process Optimization: Optimized cartridge design and manufacturing processes, reducing layers for precision and scalability, and achieving scalable antibody coating processes for the SepTec sensor.
Objective 7 – Regulatory Pathway: Completed EU and US FDA regulatory assessments, IVD classification, and submitted a Breakthrough Device Designation application to the FDA, paving the way for regulatory compliance.
Objective 8 – Quality Management System (QMS): Implemented a compliant QMS, including ISO 13485, ISO 9001, and FDA 21 CFR 820, and completed Phase 0 of QMS implementation.
Objective 9 - Go-to-market strategy: Formulated a comprehensive go-to-market strategy, including impactful health economics studies, collaborative business plans, innovative pricing models, and positioning SepTec for sales and growth opportunities.

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)

Beyond the project we will execute a large-scale multi-centre clinical study, achieve CE marking and FDA approval and begin to penetrate target markets.
The overall objective is to reduce the devastating effects of infection and Sepsis onset in critically ill patients. This would have global impacts by providing an invaluable solution to diagnosing patients with infection and Sepsis onset earlier, translating to more rapid diagnosis, more relevant treatment, reduced hospital stays, reduced mortality and overall reduced healthcare costs.

Novus point of care analyser and SepTec sepsis test cartridge