FDA Approves New DNA-Based Test to Verify Blood Compatibility
Assay can be used to determine blood donor and patient non-ABO red blood cell types
FRIDAY, Oct. 12, 2018 (HealthDay News) -- 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.
Patients 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," Peter Marks, M.D., director of the FDA Center for Biologics Evaluation and Research, said in a statement.
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.