FDA Approves DNA-based Blood Compatibility Test

The US Food and Drug Administration (FDA) has approved ID CORE XT, a molecular-based test used to help determine blood compatibility in the area of blood transfusion medicine.

The ID CORE XT test can identify blood donor and patient non-ABO red blood cell types. It is the first molecular assay to report genotypes as final results and the just the second molecular assay approved for use in transfusion medicine.

“The approval of the ID CORE XT Test can streamline blood compatibility testing and provides an additional alternative to testing blood with antisera,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “We know that DNA testing holds great promise — to provide more informative, accurate and cost-effective methods that can enhance patient care.”

Blood type testing is important for matching blood types for transfusions, especially as people who receive repeated blood transfusions, such as patients with sickle cell disease, can develop antibodies to non-ABO antigens.

The FDA’s approval was based in part on data from a study comparing ID CORE XT test typing results to results from licensed serological reagents, the first FDA-approved molecular assay, and DNA sequencing tests.

The study included 1000 blood samples that were tested for 29 polymorphisms, resulting in 29,000 ID CORE XT calls. No samples showed an invalid analysis using the ID CORE XT test. Initially, 10 samples were apparently incorrectly identified, but all were resolved, and the system failure rate was 0%.

“The results of this study showed that the ID CORE XT assay performed as a reliable and accurate method for correctly predicting red blood cell phenotypes of clinically relevant blood group antigens,” wrote study authors Mónica López, Progenika Biopharma, a Grifols Company, Derio, Spain, et al.

The FDA approval was granted to Progenika Biopharma S.A., a Grifols company, which sponsored the study.