Immucor (BLUD) has received CE Mark approval for its Human Erythrocyte Antigen BeadChip product for molecular immunohematology in vitro diagnostic purposes. The approval is significant for the company as there is strong potential in the European market for molecular methods in the blood bank industry. Moreover, this product will enable blood banks to improve patient safety over procedures currently available.
With the acquisition of BioArray Solutions in 2008, Immucor is focusing on molecular immunohematology, which is believed to be the future of blood bank industry. In many countries, blood testing pre-transfusion is limited to the prevention of transfusion reactions and not for the prevention of alloimmunization, which occurs when antigens foreign to the patient are unintentionally introduced into the patient’s blood system, thus complicating future transfusions.
Immucor is working on a technology which is expected to introduce a test that will target the prevention of alloimmunization, facilitating better patient care.
During the third quarter of fiscal 2010 Immucor generated $1,632 million from molecular immunohematology, representing 2% of total revenues. The segment is likely to increase its contribution as more products are developed.
In April 2010, Immucor received US Food and Drug Administration (FDA) approval for its fourth generation automated instrument, Neo. The instrument has already been launched in the European markets and is expected to replace the existing Galileo in due course. We believe Immucor’s portfolio of a large test menu along with various instruments can cater to different testing volume demands of blood banks, hospitals and clinical laboratories. However, we remain concerned about the quality process improvement project, which has yet to be validated by the FDA.
We are Neutral on the stock.
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