HEMEX HEALTH INC — Department of Health and Human Services STTR Phase I: NHLBI

Description

PROJECT SUMMARY Anemia is characterized by low blood hemoglobin levels and has high prevalence affecting over one-third of the worldandapos;s population or about 2.5 billion people. Anemia has numerous causes, including nutritional deficiencies, oncologic conditions, and hematologic diseases, including hemoglobin gene variants. More than 7% of the worldandapos;s population carry hemoglobin gene variants, one of which is Sickle Cell Disease (SCD). SCD or sickle cell anemia is one of the most commonly inherited blood anemias. Anemia and SCD diagnosis/monitoring are challenging in low and middle income countries due to lack of laboratory infrastructure and skilled personnel. In a 2019 report, World Health Organization has listed hemoglobin testing (diagnosis and monitoring of anemia) as an essential in vitro diagnostic tests for primary care in low and middle income countries. We have developed a point-of-care (POC) microchip electrophoresis hemoglobin variant testing system, HemeChip. HemeChip has been extensively validated in the US, Africa, India, and South-East Asia, for hemoglobin variants. In this STTR Phase I project, we plan to add total hemoglobin quantification and anemia testing capability to HemeChip system and develop HemeChip+. The proposed HemeChip+ is the first and only single test, POC platform for portable, affordable, accurate, and quantitative hemoglobin quantification, anemia detection, and hemoglobin variant identification. Based on our preliminary findings, we hypothesize that rapid, affordable, integrated, POC testing of anemia and hemoglobin variants is feasible with the proposed HemeChip+ system. To test this hypothesis, we propose the following distinct but interrelated aims: Aim1: To develop the HemeChip+ platform for integrated quantitative hemoglobin testing, anemia detection, and quantitative hemoglobin variant identification. Aim 1 milestone is to achieve, in a single test, accurate total hemoglobin quantification (g/dL), hemoglobin variant identification, and hemoglobin variant percent (%) quantification using a drop of blood, in less than 10 minutes. Aim 2: To perform clinical testing of the integrated HemeChip+ anemia and hemoglobin variant testing system. Aim 2 Milestone is to validate the HemeChip+ performance as an integrated assay for anemia and hemoglobin variant testing platform. Quantitative hemoglobin test performance target is andgt;90% correlation (Pearson correlation coefficient andgt;0.90, pandlt;0.01) with the results of clinical gold standard method, Complete Blood Count. Hemoglobin variant identification performance target is andgt;95% accuracy; and hemoglobin variant % quantification performance target is andgt;90% correlation (Pearson correlation coefficient andgt; 0.90, pandlt;0.01) compared with the results of the clinical gold standard method, High Performance Liquid Chromatography. The proposed HemeChip+ system is the first of its kind, single test solution, which offers an accurate, affordable, portable, and rugged platform for anemia and hemoglobin variant testing in low- and middle- income countries.PROJECT NARRATIVE Anemia is characterized by low blood hemoglobin levels and has high prevalence affecting over one-third of the worldandapos;s population or about 2.5 billion people. Anemia and hemoglobin variant diagnosis and monitoring are challenging in low and middle income countries due to lack of laboratory infrastructure and skilled personnel. In this STTR Phase I project, we propose to develop an integrated point-of-care test that is the first of its kind, which offers accurate, affordable, portable, and rugged solution for anemia and hemoglobin variant testing in low- and middle-income countries.