Profile: Immucor, Inc. (BLUD.O)

Immucor, Inc. (Immucor) develops, manufactures and sells a line of reagents and automated systems that detect and identify certain properties of the cell and serum components of human blood for the purpose of blood transfusion. The Company has manufacturing facilities in the United States and Canada and sells its products through its direct sales network in the United States, Canada, Western Europe and Japan, as well as through third-party distributors in other markets. As of May 31, 2009, the Company had received orders for a total of 603 Echo instruments worldwide, including 121 orders in Europe including distributors, 470 orders in the United States and Canada, and 12 orders in Japan. On August 4, 2008, Immucor acquired BioArray Solutions Ltd.

Traditional Reagents

Most of Immucor’s reagent products are used in tests to identify the blood group (A, B, AB, O) and type Rhesus factor (Rh) positive or negative); to detect and identify red cell antibodies or red cell antigens; to detect and identify platelet antibodies and, to determine blood compatibility (crossmatch). Under traditional agglutination blood testing techniques (manual method), the technologist manually mixes serum with red blood cells in a test tube, performs several additional procedures, and then examines the mixture to determine whether there has been an agglutination reaction. A positive reaction occurs if the cells are drawn together in clumps by the presence of corresponding antibodies and antigens.

Proprietary Technology Platform

The Company’s instruments use both its solid phase technology, marketed under the name Capture, as well as certain manual reagents to perform tests. In its proprietary solid phase blood test system, red cell or platelet antigens are bound to a solid support like a microtitration plate (the solid phase), and the bound reactant captures other reactants in a fluid state and binds those fluid reactants to the solid phase. In this testing system, patient or donor serum or plasma is placed in the well of a plastic microtitration plate, on which antigen reactants have been bound. Special proprietary indicator cells manufactured by Immucor are then added. In a positive reaction, antibodies in the test sample are captured by the indicator cells and adhere to the bottom of the test well as a thin layer. In a negative reaction, there is no antibody attached to the indicator cells and they settle to the bottom of the test well as a small cell button. It has obtained the United States Food and Drug Administration (FDA) clearance for the sale of five test systems using its solid phase technology: a platelet antibody detection system, Capture-P; a red cell antibody detection system, Capture-R and Capture-R Select, used for antibody screening, identification, phenotyping, cross matching and in the weak D test, and two infectious disease tests, Capture-CMV and Capture-S.

The Company’s molecular immunohematology technology is marketed under the name the BeadChip system. BioArray developed a technology platform that allows for a variety of multiplex deoxyribonucleic acid (DNA)-based testing, combining DNA amplification (PCR) with Beach Chip detection and data analysis software. The platform combines semiconductor technology, microparticle chemistry and molecular biology to bring a high degree of flexibility and performance to qualitative and quantitative DNA and protein analyses. Multiplex Human Erythrocyte Antigen (HEA), Human Platelet Antigen (HPA), and HLA-A/HLA-B Bead Chip kits are available to the market with Hemoglobinopathies/SCD, and Rh Bead Chip systems in development. The BeadChip system is available for research use only.

Instruments and Instrument Systems

Immucor offers customers a selection of automated analyzers, marketed as Scalable Solutions, which address the various needs of low, medium, and high-volume testing facilities. While the Company designs and owns the rights to its instruments, it contracts with third-party manufacturers for their production. The Galileo provides a fully-automated solution to perform all routine blood bank tests, including blood grouping, antibody screening, crossmatch, direct antiglobulin test (DAT), antibody identification, cytomegalovirus (CMV) and syphilis screening.

The Echo has many of the features of the Galileo, including a test menu. Echo has the capacity to load 20 samples at a time and can perform approximately 14 type-and-screen tests an hour. The Capture Workstation has semi-automated components for performing its Capture assays manually. It is marketed as a back-up system for its fully-automated Galileo and Echo, or as a standalone test system for small laboratories looking to standardize testing.

The Company competes with Johnson & Johnson, Bio-Rad Laboratories, Inc., Hemo Bioscience, Grifols Diagnostics, Biotest and Ortho-Clinical Diagnostics.