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People who need repeated transfusions, such as those with sickle cell disease, are more likely to develop certain antibodies. If blood with poorly-matched antibodies is transfused, the procedure is more likely to lead to red-blood-cell destruction and a transfusion reaction, the agency explained.
“We know that DNA testing holds great promise — to provide more informative, accurate and cost-effective methods that can enhance patient care,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Traditionally, identifying red blood cell antigens requires use of a blood serum called antisera. This method has limitations, and the serum may be difficult to obtain.