Mologic Ltd, a developer of lateral flow and rapid diagnostic technologies, services and products, announced that it has finished recruitment to a major clinical trial with University College London Hospitals (UCLH) to evaluate the Company’s point-of-care (POC) diagnostic test for the early detection of sepsis.
The trial is being led at UCLH by Professor of Intensive Care Medicine, Mervyn Singer, a global expert in sepsis and critical care, and lead author of the new international sepsis definitions (Singer et al, JAMA 2016).
Sepsis – organ failure resulting from an infection - affects approximately 30 million people every year, with more than a quarter of cases resulting in death. Survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult.
Mologic is developing a novel, high performance POC test leveraging lateral flow immunoassay technology to aid the diagnosis of infection and early detection of sepsis using a panel of six host biomarkers. The assay will use an algorithm to detect emergent sepsis, aiming to differentiate it from less critical infections and from non-infectious complications, with a qualitative result in ten minutes. The work is supported by a grant from Innovate UK.
Dr. Joe Fitchett, Medical Director at Mologic commented: “Early detection of sepsis continues to be a challenge, with single biomarker diagnostics not delivering sufficiently specific results. Improved point of care diagnostics are needed to detect sepsis early and initiate life-saving interventions. Mologic’s multi biomarker panel provides rapid, clinically actionable results with the potential to transform how sepsis care is delivered. We are delighted to be working with Prof. Singer, Dr David Brealey, and the clinical trials team at UCLH to build further evidence on the test’s accuracy, utility, and clinical performance.”
Mervyn Singer, Professor of Intensive Care UCLH added: “Early diagnosis of infection and sepsis represents a major ongoing challenge as signs and symptoms are often non-specific in the initial stages. Prompt and accurate identification will both facilitate appropriate treatment while avoiding unnecessary use of antibiotics in patients who will not benefit. The Mologic assay has the potential to be a game changer as it offers a near-bedside tool that can provide rapid results.”