FDA Approves Progenika MDx Assay for Blood Compatibility

NEW YORK (360Dx) – The US Food and Drug Administration announced after the close of the market on Thursday that it has approved a molecular assay to determine blood compatibility for blood transfusions.

Progenika Biopharma's ID Core XT test can be used to determine blood donor and patient non-ABO red blood cell types, the FDA said, adding it is the second molecular assay approved for use in transfusion medicine and the first to report genotypes as final results. The test has been CE-IVD marked in Europe since 2014, said Progenika's parent firm Grifols, a Spanish biotech and diagnostic firm, separately. 

The first molecular assay to get FDA approval for use in transfusion medicine to help in determining blood compatibility was Immucor's PreciseType HEA test in 2014.

Blood can be grouped based on the antigens on the surfaces of red blood cells, and the presence or absence of blood group antigens other than the ABO blood group antigens can be important in matching blood for transfusions. Red blood cell antigens have typically been identified with serological methods involving the use of antisera, a blood serum that contains antibodies for testing. However, serologic testing has limitations and certain antisera may be scarce or unavailable, the FDA said.

In a study comparing typing results from ID Core XT with licensed serological reagents, the Precise Type HEA test, and DNA sequencing tests, Progenika's test demonstrated comparable performance with the other methods, the agency said.

Grifols added that patients who require ongoing transfusions, including those with hemoglobinopathies, such as sickle cell disease and thalassemia, will benefit from the ID Core XT test. Additionally, the test will be used with cancer patients who require more thorough blood typing. 

Grifols will make the test available soon for use in the laboratory and as a send-out testing service from the Grifols Immunohematology Center in San Marcos, Texas, it said.