Progenika Biopharma SA, a Grifols SA company, received the U.S. Food and Drug Administration's approval for its ID CORE XT test to determine blood compatibility for transfusions.
ID CORE XT gained the approval as a molecular-based assay used in blood transfusion medicine to help determine blood donor and patient non-ABO red blood cell types.
Human blood can be categorized into different groups based on antigens on the surfaces of red blood cells. In addition to the ABO blood group antigens, the presence or absence of other specific blood group antigens can be important when matching blood for transfusions since some people develop antibodies to non-ABO antigens, which affect less common human blood groups.
If red blood cells with poorly matched non-ABO antigens are transfused, red blood cell destruction and a transfusion reaction can occur in a transfusion recipient.
The U.S. regulator's approval is based on a study that compared the typing results of ID CORE XT with licensed serological reagents, the first FDA-approved molecular assay and DNA sequencing tests. The results showed comparable performance between the two testing methods.
Progenika Biopharma focuses on the research, development and production of molecular biology tests for the studies of transfusion compatibility, diagnosis of genetically complex diseases and production of immunological tests for monitoring biological drugs.