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    Impact

    • Universal screening is possible with HemoTypeSC™. 
    • Governments, hospitals, NGOs, and health organizations of all sizes can now efficiently and inexpensively screen large populations of all ages. 
    • Early and fast diagnosis means patients can have significantly improved survival rates and positive outcomes.

    HemoTypeSC in the News

    ASH Conference 2018

    "$2 Test Could Transform Sickle Cell Dx in Africa"

    December 13, 2018

    "An inexpensive, easy-to-use blood test could dramatically alter how sickle cell disease is diagnosed in Africa, where the often-undiagnosed disease is a leading cause of childhood mortality, according to a manufacturer-sponsored study presented here."

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    "New Sickle Cell Test Can Transform Screening"

    December 13, 2018

     
      
     "A new test that costs less than $2, requires only a small drop of blood, and can be performed in about 10 minutes could dramatically change the dynamics of sickle cell diagnosis in Africa, say researchers who developed the product."
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    HemoTypeSC Presented in Late-Breaking Abstract

    December 13, 2018

    "A trial in Uganda showed a new test called HemoTypeSCTM was more than 99 percent accurate in detecting sickle cell disease in young children. The test requires only a small drop of blood and returns results in about 10 minutes, making it suitable for routine screening of newborns."
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    Field Validation Trial Data Dissemination Event - Abuja, Nigeria

    Lack of Funds Hinders Govt’s Policy on SCD

    December 13, 2018

    Dr. Alayo Sopekan, National Desk Officer, Ministry of Health, said: “Nigeria has the highest burden of Sickle Cell Disease (SCD) in the world ahead of Democratic Republic of Congo and India.”  He called for early diagnosis and treatment of the disease.

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    Nigerian Health Ministry Introduces POC Testing

    January 30, 2018

    Video: Nigerian officials reveal how the country loses over 150,000 newborns to sickle cell disease every year. OakTV presents a report on the accuracy of HemoTypeSC™, a 10 minute investigational test kit. 

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    Experts Advocate Newborn Screening for Sickle Cell

    January 30, 2018

    Video: Professor Obiageli Nnodu, sickle cell disease expert from the University of Abuja, describes the current status of sickle cell disease in Nigeria and the results from early testing with HemoTypeSC™.

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    Peer-Reviewed Manuscripts

    Point-of-care screening for sickle cell disease in low-resource settings: A multi-center evaluation of HemoTypeSC, a novel rapid test.
    Point-of-care screening for sickle cell disease in low-resource settings: A multi-center evaluation of HemoTypeSC, a novel rapid test.

    Steele, et al. Am J Hematol. 2018 Oct 5.

    Here, we describe a global, multicenter evaluation of the diagnostic performance of HemoTypeSC for detecting sickle cell disease, HbC disease, and the related carrier states (HbS trait and HbC trait) using whole blood at the point-of-care in limited-resource environments.  The test had 100% sensitivity and specificity for sickle cell anemia. Sensitivity and specificity for detection of normal and trait states were >99%.

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    A rapid, inexpensive and disposable point-of-care blood test for sickle cell disease using novel, highly specific monoclonal antibodies.
    A rapid, inexpensive and disposable point-of-care blood test for sickle cell disease using novel, highly specific monoclonal antibodies.

    Quinn, et al. Br J Haematol. 2016 Nov;175(4):724-732.

    This manuscript details our initial laboratory development of HemoTypeSC™, based on novel monoclonal antibodies (MAbs) that differentiate normal adult haemoglobin (Hb A), sickle haemoglobin (Hb S) and haemoglobin C (Hb C).

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    Regulatory

    HemoTypeSC™ has a CE Mark

    The HemoTypeSC™ test has received the CE Mark, which is a certification that indicates conformity with health and safety standards set by the European Economic Area (EEA).  HemoTypeSC™ is thus commercially available as an IVD in the EEA, and the CE Mark will facilitate availability of the test to all African and Indian populations that need it most.