NEW YORK (GenomeWeb) – Immucor announced Friday that the US Food and Drug Administration has approved the company's PreciseType HEA test to screen blood donors for sickle cell trait (SCT).
The molecular assay — which detects genes that control the expression of antigens that can appear on the surface of red blood cells — received FDA approval in mid-2014 for evaluating blood compatibility between donors and patients to help prevent transfusion mismatches. With the latest approval, the test can be used to screen for SCT, a condition in which an individual carries one of the two abnormal genes responsible for sickle cell disease.
"The use of PreciseType HEA to screen donor units for patients with sickle cell disease, neonates, or any individual that may require SCT-negative blood provides a great improvement over previously used methods and offers the first FDA-approved molecular method specifically for screening units," Michael Spigarelli, vice president of medical affairs at Immucor, said in a statement.