FloBio LLC seeks to develop disposable, easy-to-use, low blood volume microfluidic chips for rapid detection of platelet function in neonatal and pediatric patients in order to guide safe use of anti-platelet agents during neonatal surgery and therapies. FloBio LLC, in conjunction with researchers at the University of Pennsylvania, has pioneered low volume microfluidic assays to monitor blood function under diverse disease and pharmacological conditions. Utilizing over a decade of experience with protein micropatterning, microfluidics, novel fluorescent biosensors, and patient blood testing, the team will convert cumbersome PDMS-based research methodologies into point-of-care (POC) disposable chips that allow scalable manufacturing and reliable bedside use. Such single-use chips will be applied to rapid patient monitoring in the context of neonatal and pediatric blood testing where only extremely small blood volumes are available for analysis. In areas such as congenital heart disease repair, membrane oxygenation and ventricle assist devices where thrombotic risks must be managed during surgery, microfluidics are ideal for testing blood function under hemodynamic conditions. FloBio will implement Phase I research on the following specific aims. Aim 1: Optimization of internal calibrants and pharmacological testing for whole blood clotting for neonate applications. Aim 2: Stability testing of FloBio chips and neonate reagent cocktails over 6 months. Aim 3: Development of neonate assay analytics and user-friendly interface. In Phase II, beta-units for chip reading will be developed and larger chip manufacturing runs will be implemented for deployment at clinical sites in the US for testing with blood obtained from neonatal and pediatric patients. In time, the FloBio chip may also help reduce risks of neonatal/pediatric bleeding or thrombosis in the clinical arenas of oncology, emergency medicine, or hemophilia.
Public Health Relevance Statement: NARRATIVE FloBio LLC proposes to design, manufacture, and validate a novel microfluidic chip to monitor whole blood function under hemodynamic conditions. The rapid and dynamic readout and large signals are essential for point-of-care (POC) use. The development of a technology that is small and easy to use will be essential for surgery room monitoring of bleeding and clotting risks for anticoagulant or antiplatelet agents in neonatal and pediatric patients, particularly in the context of congenital heart repair surgery, membrane oxygenation, and ventricle assist devices.
Project Terms: Adult; Anticoagulants; Antiplatelet Drugs; Area; Aspirin; Automation; base; Biological Assay; Biology; Biosensor; Birth; Blood; Blood coagulation; Blood Platelets; Blood specimen; Blood Tests; Blood Volume; Calibration; cardiac repair; Centers for Disease Control and Prevention (U.S.); Child; Childhood; Clinical; clinical care; Clinical Research; clinical research site; clinically relevant; Coagulation Process; Collagen; Color; Common Ventricle; Congenital Heart Defects; congenital heart disorder; Cyclooxygenase Inhibitors; Data Analyses; Deposition; design; Detection; Development; Devices; Diamond; Disease; Drug usage; Emergency Medicine; Ensure; Event; experience; Extracellular Matrix; Fibrin; Fibrinogen; Fluorescence; Fluorescent Antibody Technique; Generations; Goals; graphical user interface; hemodynamics; Hemophilia A; Hemorrhage; Hemostatic function; Image; inhibitor/antagonist; Injections; instrument; interest; Lung; manufacturing scale-up; Membrane; Microfluidic Microchips; Microfluidics; Molds; Monitor; Neonatal; neonatal death; neonatal patient; neonatal surgery; neonate; novel; Oncology; operation; Operative Surgical Procedures; Optics; Oral; Outcome; Output; Patient Monitoring; Patients; Pediatric Hospitals; pediatric patients; Pennsylvania; Pharmaceutical Preparations; Pharmacology; Phase; Philadelphia; Physiological; Platelet Activation; platelet function; point of care; point-of-care diagnostics; Population; preclinical study; Prevention; Production; Proteins; Protocols documentation; Publications; Quantum Dots; rapid detection; Reader; Reading; Reagent; repaired; Research; Research Methodology; Research Personnel; response; Risk; Running; Sampling; screening; seal; Shipping; Shunt Device; Signal Transduction; Site; Slide; software development; stability testing; statistics; Syndrome; System; Technology; Testing; Therapeutic; Thromboembolism; Thromboplastin; Thrombosis; Time; transmission process; Treatment Efficacy; Universities; user-friendly; Validation; ventricular assist device; Whole Blood
