Healthcare Industry News:  organ transplant 

Diagnostics FDA

 News Release - June 3, 2008

Invitrogen Receives FDA Clearance for Diagnostic System to Determine Transplant Compatibility

CARLSBAD, Calif.--(HSMN NewsFeed)--Invitrogen Corporation (NASDAQ:IVGN ), a provider of essential life science technologies for research, production and diagnostics, today announced it received U.S. Food and Drug Administration (FDA) clearance for its DynaChip™ Antibody Analysis System. The DynaChip™ system is the only automated chip-based system for human leukocyte antigen (HLA) antibody detection and identification. This is the first Class II IVD (Instrument, Interpretation Software, Assay) Medical Device System for which Invitrogen has received FDA 510k clearance.

“We’re very pleased to have received this FDA approval, which validates the accuracy of DynaChip data and demonstrates Invitrogen’s commitment to providing clinicians with accurate and more efficient solutions,” said Kip Miller, Senior Vice President of BioDiscovery.

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

The DynaChip™ Antibody Analysis System provides fully integrated instrumentation, reagents and software for automated detection and identification of HLA antibodies. The DynaChip™ Antibody Analysis System is composed of three parts:
  • The DynaChip™ Processor automates assay processing – from dispensing, incubation and washing to image detection and results analysis;
  • The DynaChip™ protein array allows users to test for multiple antibodies at the same time;
  • The DynaChip™ interpretation software provides rapid, efficient and automated analysis.
“The high capacity of the DynaChip allows us to add a larger number of proteins than competitive products, reducing the amount of testing and overall turn-around time,” added Jim Janicki, Vice President and General Manager of Invitrogen’s Applied Markets business unit. “With organ donations, time is of the essence and this analysis system will help physicians make fast, reliable clinical decisions.”

For more information, please visit www.invitrogen.com/dynachip.

About Invitrogen

Invitrogen Corporation (NASDAQ:IVGN ) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen’s own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, stem cells, cell therapy and cell biology -- placing Invitrogen’s products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company employs approximately 4,700 scientists and other professionals and had revenues of approximately $1.3 billion in 2007. For more information, visit www.invitrogen.com.


Source: Invitrogen

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