Validation of protein biomarkers to diagnose the early onset of sepsis

Sepsis is the clinical syndrome resulting from a host's systemic inflammatory response to infection. When severe, it is associated with considerable mortality and is a major healthcare problem.

Early and accurate diagnosis of sepsis, with timely therapeutic intervention, is crucial to improve patient outcomes and reduce health care costs.

This was a two-year research project funded by Innovate UK.
The project is a joint industry and academic partnership coordinated by Inanovate UK Ltd with academic partners from the University of Brighton and Manchester Academic Health Science Centre.

The partners worked together to develop a new category of protein screening technology to validate a panel of candidate protein biomarkers aimed at diagnosis of patients with the life threatening condition sepsis.

The project aimed to leverage a proven protein screening platform to validate a panel of candidate protein biomarkers aimed at the rapid differential diagnosis of patients with sepsis from those with systemic inflammatory response syndrome (SIRS). If successful, the validated markers would be advanced onto an automated version of the platform to facilitate clinical use at the point-of-care.

The original goals of the project can be broken into three overarching categories:

Develop a multiplex panel of candidate sepsis biomarkers and assess their potential to differentiate sepsis from SIRS.

The original objective was to develop a panel of candidate biomarkers known to have links to sepsis. An initial panel of 12 markers was condensed to a high priority 6-plex which was run across patient samples. Results indicated increased levels of cytokines IL-6 and IL-8, and high levels of these markers in a statistically significant subset of SIRS samples raising interesting questions about the reliability of SIRS criteria in indicating patients most at risk of infection.

Advance and validate the performance/benefits of a novel multiplexing platform for biomarker screening.

This component of the project focused on the advanced development of the Bio-ID platform by Inanovate. Advances were made in the laser system and a valve-free’ fluidic cartridge system, resulting in a significant upgrade for the Bio-ID system and positions the system much more effectively as Inanovate builds towards commercial launch of the system with selected beta sites.

Pending positive biomarker validation, position both platform and biomarker panel for further trials to assess clinical utility and ready for commercial launch.

The work on the biomarkers did not deliver a conclusive set of markers to advance into further trials. However, sufficient progress was made to warrant further investigation into the 6-plex, and extend this multiplex into a large panel of candidate markers for continued screening. The consortium members intend to source further funding opportunities to continue building towards a clinically useful marker panel.