FDA News

FDA approves DNA-based assay for blood transfusion compatibility

The FDA approved ID CORE XT, a molecular-based assay, to be used to determine blood compatibility prior to blood transfusions.

The assay (Progenika Biopharma) can be used to determine the non-ABO red blood types of the blood donor and patient.

The FDA based this approval on comparisons of results from the ID CORE XT test with data from licensed serological reagents, another FDA-approved molecular assay and DNA sequencing tests.

Result showed comparable performance between the tests.

“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 press release. “We know that DNA testing holds great promise — to provide more informative, accurate and cost-effective methods that can enhance patient care.”

The FDA approved ID CORE XT, a molecular-based assay, to be used to determine blood compatibility prior to blood transfusions.

The assay (Progenika Biopharma) can be used to determine the non-ABO red blood types of the blood donor and patient.

The FDA based this approval on comparisons of results from the ID CORE XT test with data from licensed serological reagents, another FDA-approved molecular assay and DNA sequencing tests.

Result showed comparable performance between the tests.

“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 press release. “We know that DNA testing holds great promise — to provide more informative, accurate and cost-effective methods that can enhance patient care.”