SBIR-STTR Award

This SBIR Phase I project proposes to develop a device for better, early screening of sepsis. Sepsis costs the U.S. health care system over $24 billion every year, with as many as 3.1 million cases that claim over 300,000 lives annually. One out of every two to three hospitals deaths in the U.S. is due to sepsis. There are an estimated >19 million cases worldwide, and some reports have estimated that 1 person dies from sepsis every 4 seconds. Mortality rates due to severe sepsis are between 20% and 50%. The most urgent problem is a lack of accurate early screening methods. Survival rates drop by 7.6% per hour treatment is delayed. Current screening for sepsis utilizes the SIRS criteria, which include temperature, heart rate, respiratory rate, and total WBC count. These parameters have very low specificity for early screening of sepsis. This project will replace these parameters with a panel of cell and protein biomarkers to provide highly specific and sensitive detection and stratification for sepsis. A hand-held point-of-care device and a one-time-use cartridge capable of providing total white blood count, lymphocyte, granulocyte/monocyte, and CD64 Neutrophils all from one drop of blood in a single cartridge will be developed. Such a system could save hundreds of thousands of lives and billions of dollars in healthcare costs every year in the United States.This project will develop a point of care sensor that can measure cell counts and proteins from a drop of blood. The technology combines the power of microfluidics, microfabrication, and on-chip electrically based cell and particle counting to develop a revolutionary new technology that combines electrical coulter counting with immuno-capture of cells and particles. The developed device would be the only one with the capability to offer in a single device the critical information of hematology analyzers, flow cytometers, protein, and DNA assays. This project enables the power of all of these tools to be harnessed from a single inherently simple, powerful, and scalable, platform. Such a device could dramatically increase both the frequency and the multiplexing of sampling of biomarkers from patient populations. In this proposal, commercial grade cartridges will be used to develop protein measurements for procalcitonin, an FDA approved biomarker for sepsis, in addition to cell counting, from drop of blood of healthy and sick patients from hospital settings.

Sepsis is a poorly understood clinical syndrome and is characterized by a dysregulation of the immune system?s response to infection. It is the leading cause of death and is the most expensive condition treated in U.S. hospitals, exerting a $20.3 billion burden annually, 5.2% of total costs to the healthcare system nationwide. Sepsis is highly time critical and every 1-hour delay in antibiotics is associated with a 3-7% increase in the odds of a poor outcome. There is currently a dire need for a tool that can quickly assess if a patient is at risk for sepsis. Such a tool would ideally gather any relevant information very quickly and provide a probability of sepsis directly back to the physician in less than 30 minutes. If this tool were available, a lot of the uncertainty revolving around early sepsis screening could be minimized. Outcomes such as mortality, readmission rate, length of stay, length of ICU stay, hospital cost, and compliance to Center for Medicare and Medicaid Services Core Measures could all be improved by such a tool.The goal of the SBIR Phase I project was to establish the feasibility of a point of care sensor that can measure cells and proteins from a drop of blood for the eventual stratification of sepsis. In Phase II, work will continue with our manufacturing partners to design, optimize, and test a one-time-use cartridge and a portable reader for the simultaneous measurement of cells and proteins from a small volume of blood. The objective will be to develop a scalable technology platform, that can measure total white blood cell count, CD64 expression on neutrophils, and 2 proteins (IL-6, and PCT), simultaneously from the same drop of blood, and also be able to measure different proteins by changing the types of beads used in the assay. The goal is to allow physicians and healthcare providers to perform frequent measurements at the point of care, and to integrate the clinical and biological data to predict sepsis and organ dysfunction. The result of this project will be a fully functional reader and accompanying disposable cartridges for the measurement of these critical sepsis biomarkers.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.