CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
March 2019—The FDA has approved ID Core XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell types. ID Core XT is the second molecular assay approved for use in transfusion medicine and the first to report genotypes as final results.
“The approval of the ID Core XT Test can streamline blood compatibility testing and provides an additional alternative to testing blood with antisera,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a release from the FDA. “We know that DNA testing holds great promise—to provide more informative, accurate, and cost-effective methods that can enhance patient care.”