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

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.

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