CARLSBAD, Calif., Oct. 25, 2011 /PRNewswire/ -- Life Technologies Corporation today announced that its Applied Biosystems 3500 Dx Genetic Analyzer has been approved by China's State Food and Drug Administration(SFDA) for diagnostic use in China. The 3500 Dx is a capillary-based Sanger Sequencer intended for use in the analysis of human DNA or RNA for the detection of genetic changes that may lead to disease presence or susceptibility.
"Approval by SFDA means that hospital laboratories and patients across China will benefit from the accuracy and reliability of the 3500 Series platforms," said Siddhartha Kadia, President of Life Technologies, Greater China . "A number of diagnostic applications could be developed for the 3500, such as infectious disease and virus detection, genetic disease and cancer mutation identification for targeted drug therapies, as well as prenatal chromosome disorder detection."
Applied Biosystems Sanger Sequencers supplied the technology that powered the Human Genome Project, and Sanger instruments remain the sequencing "gold-standard" for accuracy, reliability and ease of use. The 3500 Dx instruments were designed with clinicians in mind, featuring a novel consumables design that incorporates the ability to track information with radio frequency identification (RFID) tags, new optical and thermal sub-systems, as well as redesigned data collection and analysis software, creating a cost-effective method for sample analyses. Depending on the degree of multiplexing, the 3500 Dx Series can run up to 1,100 sequencing or 1,200 genotyping samples per day.
The 3500 Dx instruments are CE-marked for in vitro diagnostic use in Europe and are also available in Japan, Australia, India, New Zealand, Singapore, and Taiwan. In August 2011, the 3500 Dx was submitted to the U.S. Food and Drug
Administration, along with the company's Invitrogen SeCore® HLA Sequencing System for HLA typing, an essential component of determining organ and bone marrow transplant compatibility between donors and patients. In May 2011, Life Technologies announced a partnership with Gen-Probe, Inc. for development of diagnostic assays for the platform, and continues to seek additional partners to develop the assay menu.
The 3500 Dx Series Genetic Analyzers are part of a broader portfolio of advanced genomic technologies that are built upon Applied Biosystems legacy of providing platforms that are recognized for proven technology, reliability and performance. They provide an integrated solution that combines the instrument with Applied Biosystems reagents, consumables, software, and world class service and support.
About Life Technologies
Life Technologies Corporation is a global biotechnology company dedicated to improving the human condition. Our systems, consumables and services enable researchers to accelerate scientific and medical advancements that make life even better. Life Technologies customers do their work across the biological spectrum, working to advance the fields of discovery and translational research, molecular medicine, stem cell-based therapies, food safety and animal health, and 21st century forensics. The company manufactures both molecular diagnostic and research use only products. Life Technologies' industry-leading brands are found in nearly every life sciences lab in the world and include innovative instrument systems under the Applied Biosystems and Ion Torrent names, as well as,
the broadest range of reagents with its Invitrogen, Gibco, Ambion, Molecular Probes and Taqman products. Life Technologies had sales of $3.6 billion in 2010, has a workforce of approximately 11,000 people, has a presence in approximately 160 countries, and possesses one of the largest intellectual property estates in the life sciences industry, with approximately 3,900 patents and exclusive licenses. For more information on how we are making a difference, please visit our website: http://www.lifetechnologies.com. Follow Life Technologies on Twitter @lifetech and on Facebook.
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