FDA Approves Immucor's Molecular Assay To Determine Blood Compatibility

Immucor announced in a press release that the Food and Drug Administration (FDA) has approved its wholly owned subsidiary BioArray Solutions’ molecular assay. This is the first ever FDA-approved molecular assay for genetic matching in blood compatibility. The PreciseType HEA test will help blood banks obtain a detailed genetic report, enabling them to reduce the risk of hemolytic reactions and alloimmunization. The test will also provide a way to identify donor blood containing rare antigens. The in-vitro diagnostic (IVD) has been approved in Europe since 2010.

William A. Hawkins, Immucor President and CEO said, "Our PreciseType HEA test is the first in a line of Immucor's personalized-medicine diagnostics that uncover specific gene variants in patients and donors to provide the closest match possible in transfusion applications.”

PreciseType HEA Diagnostic

The PreciseType HEA diagnostic test predicts blood compatibility between donors and patients. Matching donors more effectively can help prevent adverse reactions, some life-threatening. The test examines the surface of red blood cells, detecting genes that express antigens. The test identifies 11 blood groups and 35 red blood cell antigens. Knowing in advance the patient’s and the donor’s antigen profile helps prevent alloimmunization, or the immune system’s rejection of the donor red blood cells. Additionally, when profiling blood, blood banks can identify rare blood and use it appropriately. 

The FDA said in its press release on the approval that antibody development to non-ABO antigens is preventable by finding blood matched to the patient‘s non-ABO antigens. If a transfusion recipient is known to have a red blood cell destruction antibody, blood banks can find red blood cells that are negative for the corresponding antigen. Due to scarce or unavailable antisera (reagent blood testing) used for traditional serological typing, the FDA says that the Immucor PreciseType HEA Molecular BeadChip Test is an “alternative to serological typing and may enhance patient care in certain situations.”

Blood Transfusion

The scientific community has been studying transfusion genetics for over two decades with the hope of making precise molecular matches. Antigen typing has been considered impractical due to the cost and time involved. Each year, almost five million Americans need blood, but many patients who need blood often, like sickle cell patients, are hesitant to receive blood due to the possible adverse reactions. About two to six percent of people receiving blood encounter alloimmunization, an immune response to the donor antigens. Sickle cell patients and other chronic blood users have alloimmunization rates as high as 36 percent.