Immucor last week said it has received a CE-IVD Mark for its Human Erythrocyte Antigen BeadChip for molecular immunohematology in vitro diagnostic purposes.
The multiplex test performs extended typing of 32 red blood cell antigens, predicting the phenotypes of the Rh, Kell, Duffy, Kidd, MNS, Lutheran, Dombrock, Landsteiner-Wiener, Diego, Colton, and Scianna blood group systems.
While the assay has been available for research use in Europe, the company believes its certification as an in vitro diagnostic will allow more users in blood banks, clinical laboratories, and blood donor centers to adopt the technology.
Gioacchino De Chirico, president and CEO of the Norcross, Ga.-based firm, said that European regulatory clearance is a "significant commercial milestone" for Immucor, which has run 200,000 HEA tests on the system to date. "We view Europe as a key market to drive continued adoption of molecular methods in the blood bank," De Chirico said in a statement.
Immucor has already received CE Mark approval for its Human Platelet Antigen assay for use in platelet genotyping, as well as its instrument, the Array Imaging System.
The molecular immunohematology test provider gained its array-based technology platform in 2008 via its $117 million acquisition of Warren, NJ-based platform developer BioArray Solutions (BAN 3/18/2008). Immucor is currently preparing a fully automated, next-generation system for a research market debut next year (BAN 4/10/2010).