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Life Technologies Starts Trials of Sequence-based Typing System

By a GenomeWeb Staff Reporter

NEW YORK (GenomeWeb News) – Life Technologies today said that it has begun clinical trials on a sequencing-based platform for human leukocyte antigen typing.

The firm said that it has contracted with a clinical research organization to oversee the studies at accredited HLA typing labs in the US. Researchers at those sites will evaluate six gene regions of the HLA system using the Applied Biosystems 3500 Dx Genetic Analyzer, SeCore kits, and uType Dx software.

Todd Laird, VP and GM of Life Technologies' Fragment and Sequence Genomics Division, said in a statement that the 3500 Dx analyzer combined with the SeCore kits can identify more than 5,500 gene variants at the nucleotide level, which he said makes it the most accurate assay.

"Our intention is to complete clinical trials and pursue 510(k) clearance of the 3500 Dx system and SeCore kits to demonstrate the utility of capillary electrophoresis and sequence-based assays as powerful tools in the molecular diagnostic laboratory," said Laird.

Life Tech expects to complete the clinical trials this summer and then submit an application with the US Food and Drug Administration for clearance of the system.

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