SCD or sickle-cell anemia (SCA) is a hereditary blood disorder characterized by loss of flexibility of red blood cells and resulting in mortality and other serious complications. The greatest burden of SCD is in sub-Saharan Africa, where 75% of the 300,000 annual global births of affected children occur. Estimates are that 50-80% of these affected children will die before reaching adulthood despite the availability of low cost, effective therapies. SCD can be diagnosed (and subsequently treated) through newborn screening programs HPLC or electrophoresis systems, but these tools are too expensive and generally unavailable in low resource environments. The World Health Organization (WHO) estimates that 70% of SCD deaths in sub-Saharan Africa are preventable and has declared SCD a Public Health Priority. Field studies need to be performed with a significant sample size for significant calculation. Sickle cell disorders are present in the US, but far more prevalent in Africa, India, and the Middle East. Additionally, the test is designed for use in low-resource environments, including rural clinics as well as US CLIA-waived sites. Field studies in clinical sites found in sub-Saharan Africa are an ideal setting to stress test the product in a low-resource environment targeting a population with the highest prevalence of disease. Our study centers will include African sites in Nigeria, Ghana, Angola, Tanzania, and Kenya but also include US sites in South Carolina. The international sites include the Aminu Kano Teaching Hospital, Hasiya Bayero Pediatric Hospital, Murtala Mohammed Specialist Hospital, and University of Abuja Teaching Hospital amongst others. US sites include the COBRA Human Services Agency, Orangeburg Area Sickle Cell Foundation, James R. Clark Memorial Sickle Cell Foundation, the Louvenia Barksdale Sickle Cell Anemia Foundation, and the Medical University of South Carolina. These sites will have facilities and staffing to conduct sampling and testing of the Sickle SCAN product. The sites will have access to established method testing, coordinated by the clinical consultant. Any compensation to foreign sites will not be drawn from SBIR funding.

Public Health Relevance

Diagnosis and early intervention of the 300,000 babies born with sickle cell disease each year can dramatically improve survival and mortality?allowing patients to live into adulthood. BioMedomics is developing a point-of- care, multiplexed lateral flow immunoassay to detect hemoglobins A, S, and C in adults, children, and newborns. The Sickle SCAN test is a simple, low-cost device for the rapid identification of sickle cell disease and trait in low-resource environments such as a rural clinic in Africa, a local pharmacy in India, or a community screening fair in the US.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZHL1)
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Klauzinska, Malgorzata
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Biomedomics, Inc.
Resaerch Triangle Park
United States
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