Life Technologies Launches 7500 Fast Dx Real-Time PCR Instrument and 3500 Dx Series Genetic Analyzer
Life Technologies Corporation (NASDAQ: LIFE), announced that its 7500 Fast Dx Real-Time PCR Instrument and 3500 Dx Series Genetic Analyzer are now available platforms suitable for in vitro diagnostics (IVD) use in Japan. Both the 7500 Dx and 3500 Dx were filed as diagnostic application instruments to the Tokyo Metropolitan Government in March.
- (1888PressRelease) May 11, 2011 - The approval of these real time PCR and sequencing systems as bona fide diagnostics platforms is a demonstration of Life Technologies' recent approval by the Tokyo Government to operate as a medical company or Market Authorization Holder (MAH) within Japan.
With the 7500 Fast Dx system, clinical laboratories and institutions in Japan that develop in vitro molecular diagnostic assays in oncology, genetic disease and infectious disease, will now be able to leverage the instrument's regulatory clearance to develop tests for clinical applications. Similarly, the 3500 Dx Series Genetic Analyzer is the first CE IVD- marked capillary electrophoresis system for nucleic acid analysis. It is 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.
The 7500 enables labs to complete real-time PCR amplification and accurately and precisely quantify nucleic acids in less than 40 minutes. The instrument's software suite includes customizable security settings, and versatile security, auditing, and e-signature applications that allow users to record all instrument operations, supporting requirements of clinical laboratories to work in a secure environment.
The 3500 Dx Series enables scientists to run up to 1,100 sequencing or 1,200 genotyping samples per day. It features a novel consumables design that incorporates the ability to track key information with radio frequency identification (RFID) tags, new optical and thermal sub-systems, and redesigned data collection and analysis software, creating a more cost-effective method for high-quality data analyses.
"Life Technologies Japan is pleased to introduce these diagnostics platforms combining best-in-class technologies with easy-to-use, clinically-compliant interfaces," said Joydeep Goswami, Head of Life Technologies Japan. "These devices will enable physicians and laboratories to rapidly develop new clinical and diagnostic assays using a platform they are familiar with. We will work closely with the developers of these assays to assist them in bringing their assays to patients quickly and safely."
"Having these market-leading platforms available for IVD assay development significantly broadens the options for molecular diagnostic companies in Japan," adds Michael Paumen, Director at Life Technologies Japan. "Our flexible partnership programs will appeal to a wide variety of needs."
The 7500 Dx and 3500 Dx platforms are already widely available in many countries in Asia, North America and Europe.
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.
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patty.zamora ( @ ) lifetech dot com