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Genetic Blood Transfusion Diagnostic Approved by FDA

Blood bag (NIH)

(National Institutes of Health)

23 May 2014. The U.S. Food and Drug Administration approved a molecular diagnostic test to help determine genetic compatibility for blood transfusions, a particular need for people requiring frequent transfusions. The PreciseType HEA Molecular BeadChip Test is made by BioArray Solutions, a subsidiary of Immucor, a developer of diagnostics for transplants and transfusions in Norcross, Georgia.

The BioArray Solutions test determines the genetic composition for major ABO blood types, and 36 antigens expressed on the surface of red blood cells found across 11 blood groups. This more comprehensive genetic matching helps prevent alloimmunization, a condition where the recipient’s immune system develops antibodies that attack the transfused blood cells. Alloimmunization is a particular concern for people needing frequent transfusions, including those with hereditary blood diseases such as thalassemia and sickle-cell anemia.

The American Red Cross says more than 41,000 blood transfusions are needed in the U.S. every day, with the average red blood cell transfusion equaling 3 pints. Sickle-cell disease affects some 70,000 people in the U.S., including 1,000 babies born each year with the condition. In addition, people diagnosed with cancer require frequent blood transfusions, sometimes daily, during their chemotherapy treatments.

Current methods for analyzing blood genetics require testing the blood with reagents specific to each antigen, which can be a lengthy process and require having all of the necessary reagents on hand. The PreciseType HEA, on the other hand, tests for all 36 antigens simultaneously, providing faster turnaround. The diagnostic also makes it possible for blood banks to identify donations with rare or unusual antigens that can be saved for special cases.

The PreciseType HEA test received a CE mark indicating approval for use in Europe in 2010. Since then, the American Red Cross has used the test for research purposes at one of its facilities.

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