CytoVale, Inc — Department of Health and Human Services SBIR Phase II: NHLBI

Description

Project Summary Sepsis an uncontrolled systemic inflammatory immune response to local infection by bacteria or fungi is responsible for more deaths than prostate cancer breast cancer and AIDS combined accounts for more than of ICU costs and is the most expensive inpatient condition in the U S $ B in annual U S healthcare expenditures in While it has been demonstrated that the time to initiating aggressive treatment is critical to improving outcomes currently mortality and decreasing costs andgt $ case emergency medicine physicians suffer from a lack of compelling diagnostic tools for detection of sepsis in the emergency department ED where andgt of sepsis cases originate in the hospital CytoVale aims to improve the sepsis treatment paradigm by offering a platform to detect abnormal systemic inflammation at initial presentation Our diagnostic platform will offer a cost effective robust and rapid sample to decision assay andlt minutes in which activated white blood cells that are indicative of uncontrolled systemic inflammation are interrogated in a label free manner In order to impact quality of care the instrument must be situated at the point of care POC where it can provide rapid results to impact patient care Currently this is not feasible due to manual operations required to prepare samples for the assay e g centrifugation pipetting and the lack of an in sample calibration Here we propose to capitalize on the success of our Phase progress of automating the process of sample preparation by now developing a fully integrated module that combines the sample preparation and deformability cytometry microfluidics into a single cartridge and instrument This will allow for the identification and triaging of patients earlier in their disease process at the ED POC from a finger prick of blood Additional cost and patient comfort benefits arise from the ability to track the course of disease and design treatments specific to patient response saving days spent in the hospital and associated costs Cytovale also proposes to develop and integrate a deformable sample control Mechanical standard particles will be used as internal controls within each sample run to ensure fidelity of the instrument readings and diagnostic accuracy Not only will this help verify reliability and consistency of experiments but will also supply a much needed calibration particle to the growing field of cellular biophysics Combined these aims will expand accessibility of powerful cell based assays at the POC Project Narrative Sepsis an uncontrolled systemic response to local infection by bacteria or fungi is responsible for more deaths than prostate cancer breast cancer and AIDS combined accounts for more than of ICU costs and is associated with $ B in annual U S healthcare expenditures There are no diagnostics that can detect sepsis early in its course in the emergency department when it is treatable with readily available antibiotics and fluids and before the onset of major organ failure which is detected by current diagnostics We propose to integrate complete automation of the first ED point of care sepsis diagnostic assay to enable rapid detection of sepsis at the point that will maximally improve patient outcomes from this deadly disease