SBIR-STTR Award

The goal of this proposal is to develop a STAT palm-sized blood counter for monitoring complete blood counts (CBC) during emergencies. Changes in blood counts can reflect acutely worsening medical conditions. For instance, a rapidly rising white blood cell count may occur during infections or leukemic blast crises. Hematocrit values may rapidly decline in traumas, gastrointestinal bleeds, and post-procedure recoveries. Platelet values may drop significantly during chemotherapy and idiopathic thrombocytopenic purpura. During these situations, close and frequent monitoring of a patient's CBC is a must to deliver the best care and treatment, whether it be blood transfusions, platelet transfusions, or drug administrations. The proposed blood counter samples a fingerstick of blood from the patient and analyzes it in real-time at the patient's side for point-of-emergency clinical decision making. This is in contrast to today's CBC measurement technologies, which require a benchtop instrument and a trained technician. The central hypothesis for this Phase I-III SBIR effort is this: microfluidic technology can be utilized to develop an integrated palm-sized blood counter that requires only a pinprick of blood. The proposed 12-month $100,000 Phase I research is based on work at the DNA Medicine Institute that includes developments in flow-focusing, detection, micromixing, and integration. For each of these areas, we have conceived or discovered novel approaches that can potentially augment accuracy, increase integration, and diminish the size of our blood counter. These miniaturized advances will be explored in our Specific Aims. Specific Aim 1 will identify the optimal flow-focusing and detection format for measurement of cell counts and volume. Specific Aim 2 will characterize prototype low Reynolds number micromixers with respect to mixing efficiency, functional Re, and blood compatibility. Specific Aim 3 will assess the performance of our prototype integrated microfluidic blood counter in measuring hematocrits relative to a predicate method. Successful completion of Phase I will support our core hypothesis and lead to a Phase II effort that will be utilized for developing a palm-sized prototype that is capable of bringing full hematology capabilities, a complete CBC and 5-part differential, to point-of-emergency situations. Phase III will comprise of development, FDA approvals, and commercialization. The resulting product would be applicable for emergencies in a wide-range of settings including ambulances, inpatient rooms, operating rooms, medical offices, and resource-starved settings.

Public Health Relevance:
NARRATIVE This research is relevant to public health because rapid diagnosis of blood counts can be the difference between life and death. The palm-sized blood counter product is designed to provide much needed medical information during critical emergencies.

Thesaurus Terms:
Ambulances; Analysis, Data; Area; Assay; Bioassay; Biologic Assays; Biological Assay; Bizzozero's Corpuscle/Cell; Blast Crisis; Blast Phase; Blast Phase Cml; Blast Phase Chronic Granulocytic Leukemia; Blast Phase Chronic Myelocytic Leukemia; Blast Phase Chronic Myelogenous Leukemia; Blast Phase Chronic Myeloid Leukemia; Blastic Phase Cml; Blastic Phase Chronic Granulocytic Leukemia; Blastic Phase Chronic Myelocytic Leukemia; Blastic Phase Chronic Myelogenous Leukemia; Blastic Phase Chronic Myeloid Leukemia; Bleeding; Blood; Blood Cell Count, White; Blood Cells; Blood Platelet Transfusion; Blood Platelets; Blood Sample; Blood Volume; Blood Leukocyte; Blood Specimen; Caring; Cell Count; Cell Number; Cells; Cessation Of Life; Collection; Complete Blood Count; Coulter Counter; Cytofluorometry, Flow; Dna; Data; Data Analyses; Death; Deetjeen's Body; Deoxyribonucleic Acid; Detection; Development; Devices; Dimensions; Drops; Drugs; Electromagnetic, Laser; Elements; Emergencies; Emergency Situation; Erythrocyte Volume, Mean Cell; Erythrocyte Volume, Packed; Flow Cytofluorometries; Flow Cytometry; Flow Microfluorimetry; Fluorescence; Fluorescence Agents; Fluorescent Agents; Fluorescent Dyes; Generations; Goals; Handedness; Hayem's Elementary Corpuscle; Hct; Hematocrit; Hematocrit Procedure; Hematology; Hemorrhage; Human; Human, General; Infection; Inpatients; Institute Of Medicine; Institute Of Medicine (U.S.); Label; Lasers; Laterality; Lead; Left; Length; Leukocyte Count; Leukocyte Number; Leukocytes; Life; Linear Regressions; Man (Taxonomy); Man, Modern; Manuals; Marrow Leukocyte; Marrow Platelet; Mars; Mean Cell Volume; Measurement; Measures; Mechanics; Medical; Medication; Method Loinc Axis 6; Methodology; Methods; Methods And Techniques; Methods, Other; Microbeads; Microfluidic; Microfluidic Device; Microfluidic Lab-On-A-Chip; Microfluidic Microchips; Microfluidics; Microfluorometry, Flow; Microspheres; Mission; Modality; Monitor; Moon; Nas/Iom; Nasa; National Aeronautics And Space Administration; Operating Rooms; Packed Red-Cell Volume; Patients; Patients' Rooms; Pb Element; Performance; Peripheral Blood Cell; Persons; Pharmaceutic Preparations; Pharmaceutical Preparations; Phase; Physiologic Pulse; Planet Mars; Platelet Transfusion; Platelets; Plts; Pressure; Pressure- Physical Agent; Procedures; Process; Programs (Pt); Programs [publication Type]; Public Health; Pulse; Pump; Purpura, Thrombocytopenic, Autoimmune; Purpura, Thrombocytopenic, Idiopathic; Radiation, Laser; Rank-Sum Tests; Recovery; Relative; Relative (Related Person); Reproducibility; Research; Research Resources; Resources; Reticuloendothelial System, Blood; Reticuloendothelial System, Leukocytes; Reticuloendothelial System, Platelets; Sbir; Sbirs (R43/44); Saline; Saline Solution; Sampling; Side; Small Business Innovation Research; Small Business Innovation Research Grant; Solutions; Source; Space Flight; Spaceflight; Staining Method; Stainings; Stains; Syringes; System; System, Loinc Axis 4; Trnsf; Techniques; Technology; Testing; Thrombocytes; Time; Training; Transfusion; Trauma; United States National Aeronautics And Space Administration; Variant; Variation; Venipunctures; Venous; Volumes, Mean Corpuscular; Whblood; Werlhof's Disease; White Blood Cell Count Procedure; White Blood Cells; White Cell; Whole Blood; Work; Base; Blood Loss; Chemotherapy; Clinical Decision-Making; Commercialization; Design; Designing; Drug/Agent; Flow Cytophotometry; Fluorescent Dye/Probe; Gastrointestinal; Heavy Metal Pb; Heavy Metal Lead; Instrument; Light Scattering; Mean Corpuscular Volume Observed; Miniaturize; New Approaches; Novel Approaches; Novel Strategies; Novel Strategy; Point Of Care; Pressure; Programs; Prototype; Public Health Medicine (Field); Public Health Relevance; Rapid Diagnosis; Sensor; Success; Thrombocyte/Platelet; White Blood Cell; White Blood Corpuscle

The goal of this proposal is to develop a STAT palm-sized blood counter for monitoring complete blood counts (CBC) with 3-part differential during emergencies. Changes in blood counts can reflect acutely worsening medical conditions. For instance, a rapidly rising white blood cell count may occur during infections or a leukemic blast crises. Hematocrit values may rapidly decline in traumas, gastrointestinal bleeds, and post- procedure recoveries. Platelet values may drop significantly during chemotherapy and idiopathic thrombocytopenic purpura. During these situations, close and frequent monitoring of a patient's blood counts is a must to deliver the best care and treatment, whether it be blood transfusions, platelet transfusions, or drug administrations. These clinical scenarios reflect a significant market need. In 2007, $2.7 billion of hematology tests were performed. Of these, an estimated 25-35% of these tests were STAT tests, which are ideally performed at the point-of-care. The proposed blood counter samples a fingerstick of blood from the patient and analyzes it in real-time at the patient's side for point-of-emergency clinical decision making. This is in contrast to today's measurement technologies, which require a benchtop instrument and a trained technician. The central hypothesis for this Phase II SBIR effort is this: microfluidic technology can be utilized to develop an integrated palm-sized blood counter that requires only a pinprick of blood. The proposed 24-month Phase II effort leverages our Phase I accomplishments in microfluidics, sensitive detection, and precision measurements to develop a prototype handheld emergency blood sensor. Advances in detection and microfluidics are required to develop such a device. Specific Aim 1 will utilize our microfluidics technology to assess serial cell dilution ad red cell lysis. Specific Aim 2 will be utilized to develop an integrated optical and electrical impedance detection system required for measurement of a wide range of cell parameters. Specific Aim 3 will be utilized to develop a handheld, breadboard prototype of our STAT blood counter and validate its performance against a gold-standard blood counter across a set of clinical samples. Success in Phase II will lead to a Phase III effort which will include detailed product engineering for a commercial STAT blood counter product, tests for FDA 510(k) approval, and commercialization. The resulting product can be utilized in a wide- range of settings including ambulances, inpatient rooms, operating rooms, medical offices, and resource- starved settings.

Public Health Relevance:
This research is relevant to public health because rapid diagnosis of blood counts can be the difference between life and death. The palm-sized blood counter is designed to provide much needed medical information during critical emergencies.