SBIR-STTR Award

Sickle Cell Disease (SCD) affects 100,000 Americans and more than 14 million people globally, primarily in economically disadvantaged populations. It is estimated that nearly 50-90% of children born with SCD in these areas die before the age of five, although 70% could be saved through simple, cost-effective treatments if diagnosed early according to World Health Organization. Early diagnosis of SCD remains a challenge in the developing world due to requirements for sophisticated lab equipment and skilled personnel; therefore, an affordable, accurate point-of- care (POC) diagnostic is needed. Our device (?HemeChip?) provides the performance of a laboratory test in a product that is portable, affordable, rapid, and easy-to-use. ?HemeChip? is a miniaturized version of the standard test used in SCD screening, known as cellulose acetate hemoglobin electrophoresis, which can identify SCD with high sensitivity and specificity, as well as identify and quantify the most common hemoglobin types ? a feature that enables a more accurate diagnosis. The objective of this SBIR Phase I/II Fast-Track project is to translate HemeChip technology into a POC platform for diagnosing hemoglobin disorders, specifically SCD. In Phase I, we propose to demonstrate hemoglobin variant identification and quantification performance against quantitiative capillary electrophoresis and/or high performance liquid chromatography, which are considered to be the gold standard tests. Our Phase II aims and milestones focus on activities required for commercialization: single-use cartridge (finger/heel- stick) development, design validation and clinical testing, which will position the technology for regulatory filings. Our goal is to ensure that HemeChip technology addresses the requirements for a low-cost, easy-to-use, POC screening platform for SCD in low-income and under-resourced environments. Our proposed device will address a major gap in regions where universal sickle cell screening programs are missing or ineffective in reaching remote areas. The portable design, affordability, rapid and accurate testing makes it practical, for the first time, to effectively screen large numbers of people with sickle cell disease and other hemoglobin variants in Africa and India.

Project Terms:
accurate diagnosis; Acetates; Address; Adult; Affect; Africa; Age; American; Area; Blood; Capillary Electrophoresis; Cellulose; Child; Clinical; Collection; commercialization; Computer software; cost; cost effective; Country; design; Development; Devices; Diagnosis; diagnostic accuracy; Diagnostic Procedure; disadvantaged population; Disease; Early Diagnosis; Economically Deprived Population; effective therapy; Electrophoresis; Ensure; Environment; fetal; field study; Fingers; Glucose; Goals; Gold; Health Personnel; Heel; Hemoglobin; Hemoglobin C Disease; High Pressure Liquid Chromatography; Human Resources; India; Laboratories; laboratory equipment; Longevity; Low income; Microchip Electrophoresis; miniaturize; Monitor; Patients; Performance; Phase; point of care; point-of-care diagnostics; portability; Positioning Attribute; Preparation; Price; prototype; Reader; research clinical testing; Resources; Sampling; screening; screening program; Sensitivity and Specificity; Sickle Cell; Sickle Cell Anemia; Sickle Hemoglobin; sickling; Small Business Innovation Research Grant; Step Tests; Technology; Testing; Thalassemia; Time; Translating; United States; Validation; Variant; Work; World Health Organization;

Sickle Cell Disease (SCD) affects 100,000 Americans and more than 14 million people globally, primarily in economically disadvantaged populations. It is estimated that nearly 50-90% of children born with SCD in these areas die before the age of five, although 70% could be saved through simple, cost-effective treatments if diagnosed early according to World Health Organization. Early diagnosis of SCD remains a challenge in the developing world due to requirements for sophisticated lab equipment and skilled personnel; therefore, an affordable, accurate point-of- care (POC) diagnostic is needed. Our device (“HemeChip”) provides the performance of a laboratory test in a product that is portable, affordable, rapid, and easy-to-use. “HemeChip” is a miniaturized version of the standard test used in SCD screening, known as cellulose acetate hemoglobin electrophoresis, which can identify SCD with high sensitivity and specificity, as well as identify and quantify the most common hemoglobin types – a feature that enables a more accurate diagnosis. The objective of this SBIR Phase I/II Fast-Track project is to translate HemeChip technology into a POC platform for diagnosing hemoglobin disorders, specifically SCD. In Phase I, we propose to demonstrate hemoglobin variant identification and quantification performance against quantitiative capillary electrophoresis and/or high performance liquid chromatography, which are considered to be the gold standard tests. Our Phase II aims and milestones focus on activities required for commercialization: single-use cartridge (finger/heel- stick) development, design validation and clinical testing, which will position the technology for regulatory filings. Our goal is to ensure that HemeChip technology addresses the requirements for a low-cost, easy-to-use, POC screening platform for SCD in low-income and under-resourced environments. Our proposed device will address a major gap in regions where universal sickle cell screening programs are missing or ineffective in reaching remote areas. The portable design, affordability, rapid and accurate testing makes it practical, for the first time, to effectively screen large numbers of people with sickle cell disease and other hemoglobin variants in Africa and India.

Public Health Relevance Statement:
PROJECT NARRATIVE Up to 50 to 90% of children born with sickle cell disease (SCD) in economically disadvantaged countries (over 300,000 per year) die before the age of five, although 70% could be saved through simple, cost-effective treatments if diagnosed early according to World Health Organization. Early diagnosis of SCD remains a challenge in the developing world due to requirements for sophisticated lab equipment and skilled personnel; therefore, an affordable, accurate point-of- care diagnostic method is needed. The goal of this proposed work is to develop and commericalize technology that addresses the requirements for a low-cost, easy-to-use, point-of- care screening platform for SCD in low-income and under-resourced environments.

NIH Spending Category:
Bioengineering; Clinical Research; Clinical Trials and Supportive Activities; Health Disparities; Hematology; Prevention; Rare Diseases; Sickle Cell Disease

Project Terms:
accurate diagnosis; Acetates; Address; Adult; Affect; Africa; Age; American; Area; Blood; Capillary Electrophoresis; Cellulose; Child; Clinical; Collection; commercialization; Computer software; cost; cost effective; Country; design; Development; Devices; Diagnosis; diagnostic accuracy; Diagnostic Procedure; disadvantaged population; Disease; Early Diagnosis; Economically Deprived Population; effective therapy; Electrophoresis; Ensure; Environment; fetal; field study; Fingers; Glucose; Goals; Gold; Health Personnel; Heel; Hemoglobin; Hemoglobin C Disease; High Pressure Liquid Chromatography; Human Resources; India; Laboratories; laboratory equipment; Longevity; Low income; Microchip Electrophoresis; miniaturize; Monitor; Patients; Performance; Phase; point of care; point-of-care diagnostics; portability; Positioning Attribute; Preparation; Price; prototype; Reader; research clinical testing; Resources; Sampling; screening; screening program; Sensitivity and Specificity; Sickle Cell; Sickle Cell Anemia; Sickle Hemoglobin; sickling; Small Business Innovation Research Grant; Step Tests; Technology; Testing; Thalassemia; Time; Translating; United States; Validation; Variant; Work; World Health Organization