Invitrogen Receives Approval from Health Canada for System to Help Determine Organ Transplant Compatibility

Invitrogen, a division of Life Technologies Corporation, has announced that its DynaChip® HLA Antibody Analysis System has received approval from Health Canada’s Medical Device Bureau for the detection and identification of antibodies to human leukocyte antigen (HLA) markers, which is an essential step in determining the compatibility of organ donors.

HLA markers are proteins found on the surface of certain cells in the body. They are used by the body’s immune system to identify material that is foreign, such as viruses or bacteria. HLA antibody identification is important for organ transplant donor-recipient matching because, in the case of organ donation, a patient’s immune system may fight cells from the donor, causing organ failure or rejection.

The DynaChip HLA Antibody Analysis System, which received U.S. Food and Drug Administration clearance in 2008, is the only automated chip-based system for HLA antibody detection and identification. It consists of the following three parts:

· The DynaChip Processor, which automates assay processing, including dispensing, incubation and washing to image detection and results analysis;
· The DynaChip protein array, which allows users to test for multiple antibodies at the same time;
· The DynaChip interpretation software, which provides rapid, efficient and automated analysis.

“Health Canada has joined a growing list of medical agencies that have approved the DynaChip HLA Antibody Analysis System to help make clinical transplant decisions,” said Jim Janicki, Head of Clinical Diagnostics for Life Technologies. “This system is an important tool that can help doctors make transplant decisions more quickly and accurately.”