Posted by Michael Wonder on 11 Oct 2018
FDA approves new DNA-based test to determine blood compatibility
11 October 2018 - Test is first approved to report genotypes as final results.
The U.S. FDA today approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient 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.
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.
