Based on the huge potential in China, Life Technologies (LIFE) continues to strengthen its business in that region. Recently, the China State Food and Drug Administration ("SFDA") approval for its Applied Biosystems, 3500xL Dx Genetic Analyzer, was a major impetus for the company. As per the approval, this 3500xL Dx will be used for clinical diagnostics in China.
In addition, the joint venture of Life Technologies and Daan Gene Co. Ltd. (namely Guangzhou Life TechnologiesDaAn Diagnostics Co. Ltd) launched 10 assays based on this 3500 Dx series platform. Life Technologies remains highly optimistic about these developments and considers them to be major steps in serving the clinical end market in China with Sanger-based solutions. Moreover, the company believes these developments will help it clear the regulatory requirements for diagnostics laboratory instruments.
According to Life Technologies, these assays will be used for the detection of genotypic and drug resistance testing, cancer mutation identification and the prenatal chromosome disorder. At present, only one of these assays is SFDA registered for the use in Trisomy 21 prenatal screening for Downs syndrome and the rest of them are Research Use Only kits. Life Technologies is currently conducting clinical trials to get the SFDA approval for these 9 kits.
The company believes that these set of assays in the 3500 Dx platform will successfully g
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