Life Technologies Announces SFDA Clearance for its 3500xL Dx Genetic Analyzer in China, Launch of 10 Assays from its Joint Venture with Daan Gene


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Life Technologies Corporation(NASDAQ: LIFE) today announced that its Applied Biosystems 3500xL Dx GeneticAnalyzer has been approved by China's State Food and Drug Administration(SFDA) for clinical diagnostic use in China and the launch of 10 Assays fromits joint venture with Daan Gene.  The development marks a major extension ofLife Technologies' capabilities to serve the clinical end market in China withSanger-based solutions. The 3500xL Dx is an automated 24 capillary-based Sanger Sequencer designed fora wide range of sequencing applications. It delivers high quality performance,higher throughput and increased productivity for clinical laboratories aroundthe world. Together with Life Technologies' genetic analyzer 3500 Dx that was approved bySFDA for IVD use in 2011 in China, the 3500 series genetic analyzers areintended for use in a wide range of applications in the process of clinicalresearch, including de novo sequencing and mutational profiling as well as HLAtyping. The newly expanded offering of both the 3500 Dx and the 3500xL Dxprovides hospitals of all sizes the flexibility they need to meet their uniquethroughput demands.Based on the 3500 Dx series platform, ten assays have been developed orlicensed by Guangzhou Life Technologies DaAn Diagnostics Co. Ltd, a jointventure that established in 2012 between Life Technologies and Daan Gene Co.Ltd. of Sun Yat Sen University.  These assays will be used for genotypic anddrug resistance testing, cancer mutation identification and the prenatalchromosome disorder detection.  Currently, nine out of the ten assays areResearch Use Only kits and the other one that can be used in Trisomy 21prenatal screening for Down syndrome is SFDA registered.   The company iscurrently conducting clinical trials and is actively seeking the SFDA approvalfor the remaining nine kits.

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