New DNA-Based Test Approved to Help Verify Blood Compatibility
FRIDAY, Oct. 12, 2018 -- The U.S. Food and Drug Administration has approved the ID CORE XT DNA-based test to help doctors verify blood compatibility before a transfusion.
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, the FDA said.
The new test is produced by Progenika Biopharma, which is based in Spain.
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Posted: October 2018