- FDA on Thursday approved a molecular-based assay to help determine blood compatibility ahead of transfusions.
- The test, called ID CORE XT, is the second molecular assay approved for use in transfusion medicine and the first approved to report genotypes as final results, the agency said.
- The assay, made by Grifols unit Progenika Biopharma S.A., can be used to determine blood donor and patient non-ABO red blood cell types.
Human blood can be classified into different groups based on the antigens on the surface of red blood cells.The traditional method of identifying red blood cell antigens involves the use of antisera, a blood serum that contains antibodies for testing. But certain antisera may be scarce or unavailable, and the testing method has limitations, FDA said.
"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, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. "We know that DNA testing holds great promise – to provide more informative, accurate and cost-effective methods that can enhance patient care."
The presence or absence of specific blood group antigens is important when matching blood for transfusions because patients may have developed antibodies to non-ABO antigens. Patients who often need blood transfusions, such as those with sickle cell disease, are more likely to develop these antibodies. If red blood cells with poorly matched non-ABO antigens are transfused, a reaction involving red blood cell destruction can occur in a patient.
In addition to Grifols, major players in the blood group typing market are Bio-Rad Laboratories, Immucor, Merck Millipore, Ortho Clinical Diagnostics, Bag Health Care, Danaher, Quotient and Agena Bioscience.
FDA approved the first molecular assay used to help determine blood compatibility for transfusions, made by Immucor, in 2014. The agency said a study was conducted to compare the typing results of the ID CORE XT Test with licensed serological reagents, the first FDA-approved molecular assay, and DNA sequencing tests. The results demonstrated comparable performance between the methods.