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