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Invitrogen Gets FDA Clearance for Transplant Dx System

NEW YORK (GenomeWeb News) – Invitrogen said after the close of the market on Tuesday that it has received US Food and Drug Administration clearance to sell its new transplant diagnostics system.
The Carlsbad, Calif.-based firm received 510(k) clearance for its DynaChip Antibody Analysis System, an automated chip-based system for human leukocyte antibody detection and identification. The tests are run on protein arrays developed by the company.
“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,” Jim Janicki, VP and GM of Invitrogen’s Applied Markets business unit, said in a statement.
The DynaChip system is the first Class II IVD product for which Invitrogen has received FDA 510(k) clearance. Invitrogen CEO said during the firm’s first-quarter conference call in April that the firm expected clearance for the system during spring.
However, the transplant diagnostic system is not Invitrogen’s first entry into the diagnostics field. In addition to supplying in vitro diagnostic partners with reagents that are used in commercialized kits, the firm currently sells an HER2 chromogenic in situ hybridization diagnostic kit outside of the US and is currently awaiting FDA clearance for the kit in the US.
As reported last week by GenomeWeb Daily News, Invitrogen expects to use the new diagnostics system as the base for developing additional diagnostic applications and assays.

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