Title: Rapid Diagnosis of Bacterial Sepsis in the Acute Hospital Setting
Funder: Department of Health and Social Care

Abstract: The Sepsis Ltd point-of-care device is based on a clinically well-validated biomarker that has been shown to be positive only in bacterial sepsis and not in viral infections. This has been comprehensively tested in settings that include post-surgery, cancer, acute medical and intensive care units. It has also been shown in several studies to be better than procalcitonin and C reactive protein in identifying early sepsis. However, its detection of an optical signature was dependent on a large laboratory machine that is not universally available and affordable. With MRC funding, the biomarker was discovered to be due to a lipoprotein-complexed C-reactive protein formation. Due to simplicity of the assay, Sepsis Ltd have developed a new low-cost point-of-care device to enable rapid sepsis diagnosis and frequent, convenient monitoring of patient response to antibiotics. Collectively, this would address the important aim of improving antibiotic stewardship to meet objectives of the Department of Health &ldquo;UK Five Year Antimicrobial Resistance Strategy 2013-2018&rdquo;. Two particular selling points for this product will be (i) its utility as an early sepsis indicator and (ii) its utility for monitoring. Repeat measurement, which can be on an hourly basis, especially in intensive care, will increase sales of the disposable slides by orders of magnitude. The device combines several novel elements that include: simplicity of micro-litre sample application, unique filtration system to remove blood cells; rapid optical detection systems, scalable high volume manufacture test strips and unique algorithms to apply to a new reader. Adoption into the health service will be facilitated by clinical trials with feedback from end-users together with an in-depth health economics analysis. Indeed, a preliminary health economics report commissioned by the company, suggests that NHS adoption would be highly favoured if the device can demonstrate reduction of antibiotic use. This was also endorsed by feedback received from external multi-disciplinary experts in the field of sepsis and critical care medicine. Sepsis Ltd maintains 2 patents that have been granted in most jurisdictions and are based on the original biomarker. A further patent was filed at the end of 2012 that covers new broad claims for a device. It is intended to extend protection beyond the lifetime of the previous portfolio. An initial freedom-to-operate study showed no known impediments and protection is strong and wide for both the laboratory and point-of-care applications and methods.

Lay abstract: The Sepsis Ltd point-of-care device is based on a clinically well-validated biomarker that has been shown to be positive only in bacterial sepsis and not in viral infections. This has been comprehensively tested in settings that include post-surgery, cancer, acute medical and intensive care units. It has also been shown in several studies to be better than procalcitonin and C reactive protein in identifying early sepsis. However, its detection of an optical signature was dependent on a large laboratory machine that is not universally available and affordable. With MRC funding, the biomarker was discovered to be due to a lipoprotein-complexed C-reactive protein formation. Due to simplicity of the assay, Sepsis Ltd have developed a new low-cost point-of-care device to enable rapid sepsis diagnosis and frequent, convenient monitoring of patient response to antibiotics. Collectively, this would address the important aim of improving antibiotic stewardship to meet objectives of the Department of Health &ldquo;UK Five Year Antimicrobial Resistance Strategy 2013-2018&rdquo;. Two particular selling points for this product will be (i) its utility as an early sepsis indicator and (ii) its utility for monitoring. Repeat measurement, which can be on an hourly basis, especially in intensive care, will increase sales of the disposable slides by orders of magnitude. The device combines several novel elements that include: simplicity of micro-litre sample application, unique filtration system to remove blood cells; rapid optical detection systems, scalable high volume manufacture test strips and unique algorithms to apply to a new reader. Adoption into the health service will be facilitated by clinical trials with feedback from end-users together with an in-depth health economics analysis. Indeed, a preliminary health economics report commissioned by the company, suggests that NHS adoption would be highly favoured if the device can demonstrate reduction of antibiotic use. This was also endorsed by feedback received from external multi-disciplinary experts in the field of sepsis and critical care medicine. Sepsis Ltd maintains 2 patents that have been granted in most jurisdictions and are based on the original biomarker. A further patent was filed at the end of 2012 that covers new broad claims for a device. It is intended to extend protection beyond the lifetime of the previous portfolio. An initial freedom-to-operate study showed no known impediments and protection is strong and wide for both the laboratory and point-of-care applications and methods.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: INFLAMMATORY AND IMMUNE SYSTEM;INFECTION