SBIR-STTR Award

Diabetes is one of the most important health issues in the world. It is a disease that disproportionately affects low and middle-income countries. Not only is diabetes a major cause of morbidity and mortality, it can devastate the finances of families and strain countries' financial resources. Key components for addressing this healthcare crises include early diagnosis as well as ongoing monitoring of the condition. Access to testing, however, can be limited in many developing countries due to the lack of skilled healthcare workers as well as cost. To address this need, Hemex Health is developing an accurate, low-cost, easy-to-use hemoglobin A1C test that can be administered by an entry level healthcare worker after a short training. The test is based on our proprietary HemeChip technology known as microchip electrophoresis. The current form of the HemeChip assay accurately identifies and quantifies hemoglobin variants, and is currently in the process of commercialization with a focus on hemoglobinopathies, including sickle cell disease and thalassemia. The proposed project aims to translate the cellulose acetate based A1C electrophoresis method to the HemeChip platform as a portable, affordable, and quantitative test. For many years, the A1C test, which measures glucose control over a period of months, has become an important tool in wealthier countries for managing diabetes. It is also more convenient than glucose tests that require fasting. The Hemex device, because of its ease-of-use, portability, and affordability, can bring A1C testing to where the need is the greatest. It will offer millions of people an easy and affordable screening device and for diabetics the opportunity for regular monitoring in order to better control their disease.

Public Health Relevance Statement:
PROJECT NARRATIVE Diabetes is a disease that disproportionately affects low and middle-income countries. Effective management of diabetes should include early diagnosis and ongoing monitoring of the condition, but access to testing can be limited in many developing countries due to the lack of skilled healthcare workers as well as cost. To address this need, Hemex Health is proposing to develop an accurate, low-cost, easy-to-use A1C test that can be administered by an entry level healthcare worker after a short training.

Project Terms:
Acetates; Affect; Sickle Cell Anemia; sicklemia; sickle disease; sickle cell disease; Hemoglobin sickle cell disorder; Hemoglobin sickle cell disease; Hemoglobin S Disease; HbSS disease; Hb SS disease; Awareness; Biological Assay; Biologic Assays; Bioassay; Assay; Cellulose; alpha-Cellulose; Polyanhydroglucuronic Acid; Certification; Cessation of life; Death; Developing Countries; Under-Developed Nations; Under-Developed Countries; Third-World Nations; Third-World Countries; Less-Developed Nations; Less-Developed Countries; Developing Nations; Diabetes Mellitus; diabetes; Diagnosis; Disease; Disorder; Electrophoresis; Electrophoretic Fractionation; Cellulose Acetate Electrophoresis; Family; Fasting; fasts; fasted; Feedback; Glucose; Dextrose; D-Glucose; Glycosylated Hemoglobin; Glycated Hemoglobins; Goals; Government; Health; Health Personnel; treatment provider; medical personnel; healthcare personnel; health workforce; health provider; health care worker; health care personnel; Healthcare worker; Healthcare Providers; Health Care Providers; Health Status; Level of Health; Glycosylated hemoglobin A; hemoglobin A1c; Hemoglobin A(1); HbA1c; HbA1; Hb A1c; Hb A1a+b; Hb A1; Glycohemoglobin A; Hemoglobinopathies; Hemoglobinopathies / Iron Metabolism; Hemoglobin; Laboratories; Medical Staff; Methods; Morbidity - disease rate; Morbidity; mortality; Patients; Primary Health Care; Primary Healthcare; Primary Care; Resources; Research Resources; Running; Standardization; Technology; Testing; Thalassemia; Translating; Work; Measures; Healthcare; health care; Guidelines; base; improved; Procedures; Area; Clinical; Specified; Specific qualifier value; Phase; Variation; Variant; Ensure; Training; diabetic; point of care testing; Bedside Testings; tool; Diagnostic; Prediabetes syndrome; syndrome x; prediabetic; pre-diabetic; pre-diabetes; Prediabetic State; Prediabetes; programs; Home environment; Home; Country; meetings; Early Diagnosis; early detection; Performance; diagnostic accuracy; Accuracy of Diagnosis; Devices; Sampling; portability; microchip; Address; Microchip Electrophoresis; STTR; Small Business Technology Transfer Research; Validation; Monitor; Process; point of care; fasting plasma glucose; cost; designing; design; diabetic management; diabetes management; glucose regulation; glucose homeostasis; glucose control; blood glucose regulation; Prevalence; innovative; innovate; innovation; nondiabetic; non-diabetic; commercialization; screening; LMIC; low and middle-income countries; improved outcome

Diabetes is one of the most important health issues in the world. The number of people living with diabetes has quadrupled since 1980, with the greatest increase in prevalence in low and middle-income countries. Not only is diabetes a major cause of morbidity and mortality, but it can also devastate the finances of families and strain countries' financial resources. World Health Organization is challenging governments to achieve a 25% reduction in deaths by diabetes and other non-communicable diseases by 2025. A key part of the WHO program calls for improved diagnosis and management of diabetes in primary healthcare. For many years, the hemoglobin A1C test has been used as a reliable marker for diabetes and prediabetes, since it is the best indicator of glucose control over time. Due to the relative ease of testing of A1C versus the fasting plasma glucose test, it is often the preferred option in developing countries. Current A1C tests, however, may be inaccurate due to hemoglobinopathies, and their availability has been limited. Although monitoring of A1C in diabetics improves outcomes, current testing options are: (a) expensive laboratory tests with delayed results, (b) expensive point- of-care (POC) options not suitable for remote areas, or (c) expensive and hard-to-use home monitoring kits. We have developed a POC microchip electrophoresis system that accurately identifies and quantifies hemoglobin variants, HemeChip. This system is commercialized under the product name "Gazelle™" by Hemex Health Inc. It has been extensively validated in the US, Africa, India, and South-East Asia, with a focus on sickle cell disease and beta thalassemia. Gazelle is currently selling in 13 countries with more locations planned. In the STTR Phase I project, we successfully completed two milestones by developing (1) an easy-to-use modified functional HemeChip prototype design for glycosylated hemoglobin HbA1, and (2) a quantification algorithm to detect and quantify the relative percentages of the HbA1 and non-glycosylated hemoglobin. In this STTR phase II project we plan to: (1) develop a new approach to detect the HbA1C component within the HbA1 band which incorporates the total glycosylated hemoglobin components to comply with the National Glycohemoglobin Standardization Program (NGSP) diagnostic standard, (2) fully implement the modified design of the test cartridge into the Gazelle platform and adapt the system for use at the POC by entry level healthcare workers, and (3) clinically validate the performance of the HemeChip A1C assay. Specific aims are: Aim 1: To complete the development of a test cartridge and modify the Gazelle reader to support the A1C detection and quantification. Aim 2: To demonstrate diagnostic accuracy of the HemeChip A1C test by performing a pre-certification trial according to NGSP guidelines. Aim 3: To perform clinical testing and validation in the United States and Ghana. With its ease-of-use and affordability, the proposed POC A1C test will offer a solution that meets the needs of the developing world and other underserved regions.

Public Health Relevance Statement:
PROJECT NARRATIVE The number of people living with diabetes worldwide has quadrupled since 1980, with the greatest increase in prevalence in low and middle-income countries. There is a significant need for affordable, portable, easy-to-use diagnostic tests that rapidly quantify hemoglobin A1C, which would enable widespread screening and allow better monitoring and management of treatment. In this STTR Phase II project, we will build on our Phase I progress to develop a new approach to detect and quantify hemoglobin A1C using microchip electrophoresis and validate the performance of the test both in the laboratory setting and in field studies in low-resource and underserved regions.

Project Terms:
Africa; Algorithms; Anemia; Sickle Cell Anemia; Hb SS disease; HbSS disease; Hemoglobin S Disease; Hemoglobin sickle cell disease; Hemoglobin sickle cell disorder; sickle cell disease; sickle cell disorder; sickle disease; sicklemia; Antibodies; beta Thalassemia; B-thalassemia; p-Thalassemia; ß-thalassemia; Biological Assay; Assay; Bioassay; Biologic Assays; Buffers; Certification; High Pressure Liquid Chromatography; HPLC; High Performance Liquid Chromatography; High Speed Liquid Chromatography; Clinical Research; Clinical Study; Cessation of life; Death; Developing Countries; Developing Nations; Less-Developed Countries; Less-Developed Nations; Third-World Countries; Third-World Nations; Under-Developed Countries; Under-Developed Nations; developing country; developing nation; Diabetes Mellitus; diabetes; Diagnosis; Disease; Disorder; Electrodes; Family; Far East; East Asia; Eastern Asia; Feedback; Fingers; Ghana; Gold Coast; Glycosylated Hemoglobin; Glycated Hemoglobins; Gold; Government; Health; Health Personnel; Health Care Providers; Healthcare Providers; Healthcare worker; health care personnel; health care worker; health provider; health workforce; healthcare personnel; medical personnel; treatment provider; Health Status; Level of Health; Glycosylated hemoglobin A; Glycohemoglobin A; Hb A1; Hb A1a+b; Hb A1c; HbA1; HbA1c; Hemoglobin A(1); hemoglobin A1c; Hemoglobinopathies; Hemoglobin; India; Laboratories; Medical Staff; Methods; Morbidity - disease rate; Morbidity; mortality; Persons; Names; Patients; Primary Care; Primary Healthcare; Primary Health Care; Research Resources; Resources; Running; Standardization; Technology; Testing; Time; United States; World Health Organization; Diagnostic tests; Guidelines; Label; improved; Procedures; Site; Area; Surface; Clinical; Specific qualifier value; Specified; Phase; Variant; Variation; Ensure; Training; diabetic; Sample Size; Diagnostic; Prediabetes; Prediabetic State; pre-diabetes; pre-diabetic; prediabetic; Prediabetes syndrome; Filamentous Fungi; Molds; programs; System; Location; Country; Test Result; field based data; field learning; field test; field study; Performance; success; Accuracy of Diagnosis; diagnostic accuracy; validation studies; Devices; Sampling; performance tests; portability; Microchip Electrophoresis; Detection; Reader; research clinical testing; Clinical Evaluation; Clinical Testing; clinical test; Small Business Technology Transfer Research; STTR; Update; Validation; Monitor; Development; developmental; point of care; Image; imaging; fasting plasma glucose; cost; design; designing; novel strategies; new approaches; novel approaches; novel strategy; diabetes management; diabetic management; clinical research site; clinical site; blood glucose regulation; glucose control; glucose homeostasis; glucose regulation; Prevalence; Coupled; innovation; innovate; innovative; non-diabetic; nondiabetic; prototype; commercialization; Biological Markers; bio-markers; biologic marker; biomarker; screening; low and middle-income countries; LMIC; improved outcome; Injections; underserved area; under served area; under served geographic area; under served location; under served region; underserved geographic area; underserved location; underserved region; Home; point of care testing