US-based Immucor has obtained in-vitro diagnostic approval from the US Food and Drug Administration (FDA) for its PreciseType HEA test for molecular typing of donor and recipient red blood cells for blood transfusions.
Manufactured by BioArray Solutions, a wholly-owned subsidiary of Immucor, the PreciseType HEA test rapidly and accurately predicts blood compatibility between donors and patients to help prevent mismatches that can cause serious, potentially life-threatening reactions.
The DNA-based PreciseType HEA test works by detecting genes that govern the expression of 35 antigens that can appear on the surface of red blood cells.
This test can identify 35 red blood cell antigens from 11 blood groups simultaneously, enabling the complete blood typing of patients and donors to allow increased transfusion compatibility.
Immucor claims that the PreciseType HEA test is the first FDA-approved molecular assay designed to provide clinicians and blood banks with the detailed genetic matching information they need to reduce the risk of alloimmunization and serious hemolytic reactions, which is especially problematic for patients receiving frequent blood transfusions.
Immucor president and CEO William Hawkins said that the company’s PreciseType HEA test is the first in a line of its personalized-medicine diagnostics that uncover specific gene variants in patients and donors to provide the closest match possible in transfusion applications.
The PreciseType HEA test received CE Mark approval for in-vitro diagnostic use in 2010.