FDA approves red blood cell DNA genotype test for matching transfusions

The FDA approved its first diagnostic test that reports genotypes as a final result when evaluating blood compatibility for transfusions: a molecular assay that can be used to match donors with patient DNA.

Grifols’ Progenika Biopharma unit, based in Spain, developed the ID Core XT test to determine red blood cell types beyond the common types of A, B and O based on the antigens presented on the surfaces of the cells.

The presence of other specific antigens can be important when matching blood for transfusions, because some people can develop antibodies to non-ABO type antigens, the FDA said. Patients that receive repeated blood transfusions, such as those with sickle cell disease, can be more likely to develop these antibodies, leading to immune system reactions and the destruction of the cells.

“We know that DNA testing holds great promise—to provide more informative, accurate and cost-effective methods that can enhance patient care,” Marks added. Traditionally, red blood cell antigens have been identified through limited serologic testing methods, using certain antisera that may be scarce or unavailable, the agency said.

ID Core XT is the agency’s second molecular assay approved for transfusion medicine, after 2014’s PreciseType diagnostic test from Immucor. The cost-effective method could improve patient care options in certain situations, the FDA said at the time.

For ID Core XT’s approval, the FDA evaluated a study comparing the test’s results to licensed serological reagents, as well as Immucor’s PreciseType and DNA sequencing tests, demonstrating comparable performance.