University College London Hospitals (UCLH) and Mologic, Ltd, a UK-based diagnostic technology firm, are collaborating on a major clinical trial that evaluates the sponsor’s point-of-care (POC) diagnostic test for early sepsis detection.

The Problem: Sepsis Detection

Sepsis affects nearly 30 million people annually. Over 25% of the cases end up in death. Survivors often face impaired quality of life. A high financial and social burden associates with sepsis. Chances of survival and better outcomes increase with early detection. However, early detection is difficult.

The Detection Device

Mologic is developing a novel high-performance POC test leveraging lateral flow immunoassay technology to support 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, with the aim of differentiating it from less critical infections and non-infectious complications. The result target—within 10 minutes.

Clinical Investigator Comment

Professor Mervyn Singer of UCLH noted, “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 help provide rapid results.”

Clinical Trial Funder: Innovate UK

Innovate UK is providing a grant for the point-of-care focused study. They are the operating name of the Technology Strategy Board, the UK’s innovation agency. It is a non-departmental public body operating at arm’s length from the Government as part of the UK’s Research and Innovation organization.

Lead Research/Investigator

Mervyn Singer, Professor of Intensive Care medicine, UCLH (and a global sepsis and critical care)

Who is Mologic?

Founded in 2003 and based in the UK, Mologic has raised over $9 million from investors. They declare on their website to be a leading developer of lateral flow and rapid diagnostic technologies, products, and services in human healthcare, agriculture, and aquaculture. They collaborate with clinicians to help improve the delivery of fast and accurate diagnosis at the point-of-care. TrialSite News estimates employee count at between 50 to 75.

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Source: Mologic

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