March 27, 2013
Life Technologies Corporation
(NASDAQ: LIFE) today announced that its Applied Biosystems 3500xL Dx Genetic Analyzer has been approved by
's State Food and Drug Administration (SFDA) for clinical diagnostic use in
and the launch of 10 Assays from its joint venture with
. The development marks a major extension of Life Technologies' capabilities to serve the clinical end market in
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
, 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.