Immucor, a global provider of automated instrument-reagent systems to the blood transfusion industry, has received CE (Conformite Europeenne) mark approval for its Human Erythrocyte Antigen (HEA) BeadChip product for molecular immunohematology in vitro diagnostic purposes.
Immucor’s HEA BeadChip product, through its multiplex DNA analysis, performs extended typing of 32 red blood cell antigens simultaneously. The CE mark covers all antigens tested by the assay.
Immucor claimed that its HEA BeadChip product allows blood banks to improve patient safety over current serology testing through the enhanced matching of patient and donor blood.
Immucor has already received CE mark approval for its Human Platelet Antigen (HPA) assay for use in platelet genotyping and its instrument, the Array Imaging System and BASIS database, which facilitates the reading and interpretation of molecular test results.
The HEA BeadChip product is Immucor’s core assay for extended typing of red blood cell antigens from a DNA sample. The product predicts the phenotypes of the Rh (C,c,E,e), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Duffy, Kidd, MNS, Lutheran, Dombrock (Doa, Dob, Hy, Jo), Landsteiner-Wiener, Diego, Colton, and Scianna blood group systems.
Gioacchino De Chirico, president and CEO of Immucor, said: “European regulatory clearance is a significant commercial milestone and validates the experience we’ve gained through more than 200,000 HEA tests.
“We view Europe as a key market to drive continued adoption of molecular methods in the blood bank. We believe the DNA testing of blood prior to transfusion will improve patient safety and transform transfusion medicine.”