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Life Tech Begins Clinical Trials of CE Sequencer for HLA Typing; Plans 510(k) Clearance


Life Technologies has begun clinical trials to prove the safety and effectiveness of sequence-based typing on its 3500 Dx Genetic Analyzer for analyzing the Human Leukocyte Antigen region and plans to apply for 510(k) clearance of the SBT platform, the company said this week.

An undisclosed clinical research organization will oversee the clinical trials at several independent, accredited HLA typing laboratories in the US. These labs will use the 3500 Dx Genetic Analyzer, SeCore kits, and uType Dx software to analyze six gene regions of the HLA system.

"Our intention is to complete clinical trials and pursue 501(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 Todd Laird, vice president and general manager of Life Technologies' Fragment and Sequence Genomics division.

The company expects the clinical trials to be completed this summer, and to seek 510(k) clearance with the US Food and Drug Administration after that.

Life Tech launched the 3500 Genetic Analyzer two years ago, with a Dx version initially offered only in the European Union and, later, other countries (IS 7/13/2010). The instrument comes with either eight or 24 capillaries.

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