FDA approves Immucor PreciseType HEA test for molecular typing of RBCs for transfusions

June 4, 2014

Immucor, Inc., has announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company's PreciseType HEA test. The test has been CE-marked in Europe for IVD use since 2010.

The PreciseType HEA test provides clinicians and blood banks with the detailed genetic matching information to reduce the risk of alloimmunization and serious hemolytic reactions, which is especially problematic for patients receiving frequent blood transfusions. These include people with genetic disorders such as sickle cell disease and thalassemia and patients with certain kinds of cancer.

Unlike traditional serology-based testing, the DNA-based PreciseType test can identify 35 red blood cell antigens from 11 blood groups simultaneously. This enables the complete blood typing of patients and donors to allow increased transfusion compatibility. Better-matched blood reduces the risk of alloimmunization, in which the blood recipient's immune system develops antibodies that can attack and reject the donor red blood cells. According to Immucor spokespersons, the PreciseType test also simplifies the process of identifying donors with rare or unusual antigens so blood banks can distinguish and save scarce units for special cases.

“The medical-research community has made great strides over the last two decades in understanding the genetics behind transfusion reactions and the importance of a precise molecular match,” says Immucor President and CEO William A. Hawkins. “Until now, expansive antigen typing of most donors and patients was impractical and cost-prohibitive for blood banks and hospital transfusion centers, given the time and complexity of the work up. We are proud to be at the forefront of a new era in which precise, molecular blood donor/patient matching can finally become the standard of care.” Learn more about the PreciseType HEA test.

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