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Life Tech's 3500xL Dx Sanger Sequencer Approved by Chinese Regulators

NEW YORK (GenomeWeb News) – Life Technologies announced today regulatory approval in China for its Applied Biosystems 3500xL Dx Genetic Analyzer for clinical diagnostic use.

The company also said that 10 assays from its joint venture with Daan Gene have been launched.

China's State Food and Drug Administration gave approval to the 3500xL Dx, an automated 24 capillary-based Sanger sequencer, which can be used for a wide range of sequencing applications, Life Tech said. The 3500xL Dx and the company's genetic analyzer 3500 Dx, approved by SFDA in 2011 for in vitro diagnostic purposes, are intended for use in clinical research, including de novo sequencing, mutational profiling, and HLA typing.

With the availability of the 3500 Dx and 3500xL Dx, hospitals of any size now have "the flexibility they need to meet their unique throughput demands," Life Tech said.

In a statement, Ronnie Andrews, president of Medical Sciences at the Carlsbad, Calif.-based company, said that approval of the 3500xL Dx by SFDA "emphasizes Life Technologies' success in pursuing regulatory pathways for our diagnostics laboratory instruments as well as our vision to becoming a global leader in the molecular diagnostics industry."

Life Tech also announced that 10 assays, based on the 3500 Dx series platform, have been developed or licensed by Guangzhou Life Technologies DaAn Diagnostics, a joint venture between Life Tech and Daan Gene of Sun Yat Sen University created last year.

The assays are intended for genotypic and drug resistance testing, cancer mutation identification, and prenatal chromosome disorder detection. Nine of the assays are for research-use only, while the other is registered with SFDA and can be used for trisomy 21 prenatal screening. Life Tech added that it is conducting clinical trials and actively seeking regulatory approval in China for the other nine kits.