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FDA Approves Immucor's Blood Compatibility MDx Test

NEW YORK (GenomeWeb) – The US Food and Drug Administration on Wednesday approved the Immucor Precise Type Human Erythrocyte Antigen Molecular BeadChip Test for determining blood compatibility.

In a statement the FDA said the test is the first molecular assay to be approved by the agency for use in transfusion medicine to help in determining blood compatibility. The assay can be used to determine donor and patient non-ABO/non-RhD red blood cell types.

The FDA said that red blood cell surfaces display minor blood group antigens, as well as the major ABO blood group antigens, and that some people develop antibodies to non-ABO antigens after pregnancy or after receiving a blood transfusion. The development of these antibodies can result in red blood cell destruction if the red blood cells and the corresponding antigens are later transfused.

By better selecting blood that is matched to the patient's non-ABO antigens, the development of antibodies to non-ABO antigens can be prevented. Also, if a potential transfusion recipient has a known antibody that causes red blood cell destruction, red blood cells that are negative for the corresponding antigen must be found, the FDA said.

The Immucor PreciseType Human Erythrocyte Antigen Molecular BeadChip Test represents a new method of determining non-ABO antigens on red blood cells from the traditional method of serological typing.

The test detects genes that govern the expression of 36 antigens that can appear on red blood cell surfaces. It uses thousands of coded beads that bind with the genes coding for non-ABO red blood cell antigens that are present in a blood sample, and generates a light from each bead that has captured a specific gene. Software decodes the light signals and reports antigens that are predicted to be present on the red cells based on the genes that are detected, the FDA said.

According to Immucor, the test predicts the phenotypes of the Rh (C,c,E,e), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Duffy, Kidd, MNS, Lutheran, Dombrock (Doa, Dob, Hy, Jo), Landsteiner-Wiener, Diego, Colton, and Scianna blood group systems. The test is also designed to detect a mutation in the beta globin gene.

The assay is CE marked and commercially available in Europe and other international markets. Immucor submitted its marketing application for the test to the FDA in June 2013. Based in Norcross, Ga., the company develops diagnostic tests for transfusion and transplantations.

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