FDA OKs New Molecular Assay for Blood Compatibility Testing

Megan Brooks

Disclosures

October 12, 2018

The US Food and Drug Administration (FDA) has approved a new molecular assay, ID CORE XT (Progenika Biopharma), for use in transfusion medicine to help determine blood compatibility between donor and patient for 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 FDA said in a news release.

The Immucor PreciseType Human Erythrocyte Antigen Molecular BeadChip Test (BioArray Solutions) was the first molecular assay for blood compatibility testing approved by the FDA in 2014, as reported by Medscape Medical News.

In approving the ID CORE XT, the FDA reviewed results of a study that compared typing results of the ID CORE XT test with licensed serological reagents, the Immucor assay and DNA sequencing tests. "The results demonstrated comparable performance between the methods," the FDA said.

The surfaces of human red blood cells contain minor blood group antigens as well as the major ABO blood group antigens. The presence or absence of minor non-ABO antigens can be important when matching blood for transfusions as some people develop antibodies to these non-ABO antigens, the FDA explains.

People who receive repeated blood transfusions, such as those with sickle cell disease, are particularly vulnerable to developing antibodies. If red blood cells with poorly matched non-ABO antigens are transfused, red blood cell destruction and a transfusion reaction can occur in the transfusion recipient.

Traditionally, red blood cell antigens have been identified using serological typing that involves the use of blood serum that contains antibodies for testing (antisera). But serologic testing has limitations and certain antisera may be scarce or unavailable, the 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. We know that DNA testing holds great promise — to provide more informative, accurate, and cost-effective methods that can enhance patient care," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in the news release.

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