SeptiCyte™ quantifies directly from whole blood specific molecular markers from the patient’s own immune system – the “host response”. Immunexpress has validated hundreds of SeptiCyte™ nucleic acid expression biomarkers that, in different combinations, answer specific clinical questions to help manage patients with, and suspected of, sepsis. Patented biomarkers, algorithms and analysis methods are used to interpret information about the host response.
Immunexpress has secured patent coverage over key inflammatory and immune whole blood biomarkers relevant to sepsis following a series of novel large animal models of infectious disease, endotoxemia, and sepsis. These pre-clinical trials were conducted in 2003 to 2005 in the US and Australia. The trials were longitudinal controlled and disease-induced. Traditional murine and canine models of sepsis and sepsis-related conditions have not proven to be highly relevant to human sepsis and, most importantly, the sensitivity of humans to endotoxins is far greater than that of such species.
In contrast, initial discovery of relevant biomarkers to human sepsis using large-scale human clinical trials can be fraught with challenges, and is perhaps more appropriate to validation of classifiers than suitable for discovery. Human sepsis patients tend to be older, have multiple co-morbidities, and are medicated with a wide variety of drugs and other treatments. This creates difficulties in differentiating a true biomarker “signal” from “noise” related to the involvement of other pathophysiological pathways. This is further confounded by the lack of a true ‘gold standard’ diagnostic for sepsis.
Immunexpress, as a result of its pre-clinical approach, has gained a significant competitive advantage and time efficiencies in its product development.