FDA Approves Genetic Test to Assess Blood Compatibility

By Kelley Luedke • June 17, 2014

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The FDA recently approved the first gene-based molecular assay, Immucor PreciseType Human Erythrocyte Antigen (HEA) Molecular BeadChip Test, to be used in transfusion medicine for determining blood compatibility. Developed byBioArray Solutions Ltd., this test can be used to determine donor and patient non-ABO/non-RhD (non-ABO) red blood cell types in the United States.

According to a recent press release from the FDA, the identification of red blood cell antigens has traditionally been performed by serological typing, which involves testing blood with antisera that are specific for the antigens for which the blood is being tested. However, specific antisera may be rare or unavailable.

The PreciseType HEA Molecular BeadChip Test provides a novel method for determining non-ABO antigens on red blood cells by identifying genes that govern the expression of 36 antigens that can appear on the surface of red blood cells. The test 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. A light signal is generated from each bead that has captured a specific gene. Accompanying computer software decodes the light signals and reports which antigens are predicted to be present on the red cells based on the genes that are detected, according to the release.

Read the full article in HemOnc Today.

Kelley Luedke

Kelley Luedke is a Marketing Channel Manager at Mayo Clinic Laboratories. She is the principle editor and writer of Insights and leads social media and direct marketing strategy. Kelley has worked at Mayo Clinic since 2013. Outside of work, you can find Kelley running, traveling, playing with her kitty, and exploring new foods.