SBIR-STTR Award

Portable brain injury biomarker detection system with integrated microdialysis probe Project summary/Abstract: This SBIR application aims to integrate microdialysis with an effective, miniature pumping system and a detection system for analyzing different biomarkers in real-time and without user intervention. An integrated portable device consisting of SFC Fluidics'proprietary ePump(R), snap-on magnetic latches for rapid fluidic connection, a reagent reservoir and a microfluidic detection system will be developed. This system will facilitate real time continuous monitoring of pathological biomarkers, which in turn helps in better patient management over the course of healing/therapy. The focus of this SBIR is on monitoring Traumatic Brain Injury (TBI) sequelae with a microdialysis based system using a set of low molar mass biomarkers and a leading large molecule (protein) biomarker. In Phase I, commercially-available ELISA kits will be incorporated into SFC Fluidics integrated microdialysis and fluid handling system. The Phase II focus will be on development of a single prototype system that can quantify multiple TBI biomarkers. Phase I Research Plan Specific Aim: Design and engineer brain injury biomarker detection system with integrated microdialysis probe Task 1: Design and fabricate ePump driven integrated flow system Task 2: Detection of small molecule brain injury biomarkers Task 3: Detection of large molecule brain injury biomarker

Public Health Relevance:
An estimated 1.7 million Traumatic Brain injury (TBI) cases are reported every year in United States with 80.7 percent of them resulting in emergency department visits. There is an urgent need for development of a portable, microdialysis system with in-built analyzer which will help in rapid and continuous diagnosis of the state of health of a patient with TBI. Early and timely diagnosis of the pathological condition will help a doctor to take remedial actions and improve the quality of care of the patient while greatly mitigating long-term complications.

Thesaurus Terms:
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Portable Brain Injury Biomarker Detection System with Integrated Microdialysis ProbeProject Summary: SFC Fluidics is developing a portable, fully-integrated and automated medical device forclinical monitoring of patients with severe brain injury. The instrument will allow for automateddetection of several small molecule biomarkers, glucose, glutamate, lactate, pyruvate and urea,and a protein biomarker, S100B. These biomarkers are present in the extracellular fluid in thebrain and continuous real-time monitoring of their concentration will provide important cluesabout adverse secondary insults like ischemia, hypoxia, seizure, vasospasm and more, and willhelp in critical care of patients in neuro-ICU. SFC Fluidics will use a suite of proven, patentedtechnologies to develop the proposed instrument and make it ready for FDA approval andsubsequent clinical trials in Phase III. SFC's innovative component technologies have beentested and assembled into an initial prototype, whose basic functionality has been demonstratedduring Phase I. During Phase II, SFC will systematically and iteratively improve the design andfunctionality of the existing prototype, conduct extensive side-by-side, in vitro and in vivo testingand validate performance in an established rat model. The targeted instrument will integratemany clinically relevant and useful features to significantly change the modality of critical care ofneurotrauma patients.

Thesaurus Terms:
Animals;Arkansas;Back;Base;Biological Assay;Biological Markers;Brain;Brain Hypoxia-Ischemia;Brain Injuries;Calibration;Case Study;Cerebrum;Clinical;Clinical Trials;Clinically Relevant;Code;College;Computer Software;Controlled Cortical Impact;Critical Care;Design;Detection;Development;Dextran;Dextrans;Ensure;Enzyme-Linked Immunosorbent Assay;Evaluation;Extracellular Fluid;Failure (Biologic Function);Feedback;Glucose;Glutamates;Government;Graphical User Interface;Guidelines;Health;Hour;Immunoassay;Improved;In Vitro;In Vivo;Individual;Injection Of Therapeutic Agent;Injury;Innovation;Instrument;Intervention;Legal Patent;Life Cycle Stages;Medical Device;Medicine;Microdialysis;Modality;Modeling;Monitor;Nurses;Operation;Patient Monitoring;Patients;Performance;Persons;Phase;Pressure;Proteins;Protocols Documentation;Prototype;Public Health Relevance;Pump;Pyruvate;Quality Of Care;Rattus;Reagent;Recovery;Regulation;Reporting;Response;Running;Seizures;Sensor;Shock;Side;Small Molecule;Software Validation;System;Technology;Testing;Time;Traumatic Brain Injury;United States;Urea;User-Friendly;Variant;Vasospasm;Verification And Validation;Work;