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

Description

PROJECT SUMMARY Sickle Cell DiseaseSCDaffectsAmericans and more thanmillion people globallyprimarily in economically disadvantaged populationsIt is estimated that nearlyof children born with SCD in these areas die before the age of fivealthoughcould be saved through simplecost effective treatments if diagnosed early according to World Health OrganizationEarly diagnosis of SCD remains a challenge in the developing world due to requirements for sophisticated lab equipment and skilled personnelthereforean affordableaccurate point ofcarePOCdiagnostic is neededOur deviceHemeChipprovides the performance of a laboratory test in a product that is portableaffordablerapidand easy to useHemeChipis a miniaturized version of the standard test used in SCD screeningknown as cellulose acetate hemoglobin electrophoresiswhich can identify SCD with high sensitivity and specificityas well as identify and quantify the most common hemoglobin typesa feature that enables a more accurate diagnosisThe objective of this SBIR Phase I II Fast Track project is to translate HemeChip technology into a POC platform for diagnosing hemoglobin disordersspecifically SCDIn Phase Iwe propose to demonstrate hemoglobin variant identification and quantification performance against quantitiative capillary electrophoresis and or high performance liquid chromatographywhich are considered to be the gold standard testsOur Phase II aims and milestones focus on activities required for commercializationsingle use cartridgefinger heelstickdevelopmentdesign validation and clinical testingwhich will position the technology for regulatory filingsOur goal is to ensure that HemeChip technology addresses the requirements for a low costeasy to usePOC screening platform for SCD in low income and under resourced environmentsOur proposed device will address a major gap in regions where universal sickle cell screening programs are missing or ineffective in reaching remote areasThe portable designaffordabilityrapid and accurate testing makes it practicalfor the first timeto effectively screen large numbers of people with sickle cell disease and other hemoglobin variants in Africa and India PROJECT NARRATIVE Up totoof children born with sickle cell diseaseSCDin economically disadvantaged countriesoverper yeardie before the age of fivealthoughcould be saved through simplecost effective treatments if diagnosed early according to World Health OrganizationEarly diagnosis of SCD remains a challenge in the developing world due to requirements for sophisticated lab equipment and skilled personnelthereforean affordableaccurate point ofcare diagnostic method is neededThe goal of this proposed work is to develop and commericalize technology that addresses the requirements for a low costeasy to usepoint ofcare screening platform for SCD in low income and under resourced environments