I Corps Program for A rapid instrument free diagnostic assay for the early detection and quantification of sepsis biomarkers in blood

DESCRIPTION provided by applicant The objective of this proposed SBIR Phase I is to complete the proof of principle of a novel blood based biomarker assay for the diagnosis and management of Sepsis pScreen Sep tm pScreen Sep tm has several unique features It is fully disposable single use and does not requires external electronic equipment i e benchtop or handheld devices hence it is easy to use and very affordable it is also a quantitative and sensitive platform hence it provides an accurate and precise quantification of the level of key sepsis biomarkers such as procalcitonin PCT Current research has shown PCT to be a promising biomarker for indicating early onset of sepsis in at risk patients Severe sepsis systemic infection and organ dysfunction or tissue hypoperfusion affects over a million Americans every year and the incidence of sepsis is increasing at a drastic rate Severe sepsis kills of patients and is the th leading cause of death overall in the US while patients who survive often experience pain impaired physical functionality and overall worse health than the general population during their lifetime Sepsis and related hospitalization cost over $ billion annually in the US alone making it the most expensive condition treated in US hospitals One of the major challenges associated with effective sepsis treatment is the difficulty in early recognition and diagnosis Starting antibiotics within one hour following the observation of hypotension was found to significantly decrease mortality from sepsis yet over of patients do not receive antibiotics from more than six hours following onset of hypotension One study showed that survival decreased by per hour that antimicrobial therapy was delayed in the first six hours following the onset of hypotension A clear and critical need for a prognostc tool exists for diagnosis and management of sepsis Our solution enables physicians and first responders to rapidly monitor and diagnose potential sepsis at the Point of Care of patients pScreen sep tm is based on a patent protected technology developed at Carnegie Mellon University which has been extensively verified in our laboratory In this Phase I proposal we will optimize key elements of our latest prototype and complete a detailed validation study that includes positive and negative controls A clinical trial to support the FDA premarket approval would then follow in a Phase II effort PUBLIC HEALTH RELEVANCE Accel Diagnostics is a medical technology company based in Pittsburgh PA The current SBIR application has been submitted for the development pScreen sep tm the first disposable single use instrument free blood based biomarker assay for the diagnosis and management of Sepsis pScreen sep tm requires only a finger prick blood sample is intuitive to use very affordable and is specifically designed for point of care settings including Emergency Department and first responders