The FDA granted approval to ID CORE XT, a molecular-based assay that can be used to determine blood donor and patient compatibility. ID CORE XT is the second molecular assay approved for use in transfusion medicine, and the first to report genotypes as final results.
Human blood is classified based on the antigens on the surface of red blood cells, including the ABO blood group antigens and ABO antigens, which are more likely to develop in patients who receive multiple blood transfusions. When these patients, such as those with sickle cell disease, receive blood transfusions with poorly matched ABO antigens, cell destruction and a transfusion reaction are likely to occur.
ABO antigens have traditionally been identified by testing antisera, a blood serum containing antibodies. However, when antisera is scarce or unavailable, performing this type of testing is difficult, creating the need for alternative testing methods like DNA analysis.
The agency’s decision was based on results of a study showing that the test performed comparably to antisera-based tests.
“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.”
Source: FDA news release, October 11, 2018.