Life Technologies and Gen-Probe to Collaborate on Sequencing-Based Assays
by Suzanne Clancy - 05/17/11
CARLSBAD, Calif. – May 17, 2011 – Life Technologies Corporation today announced that the company has signed a collaborative agreement with San Diego-based Gen-Probe Incorporated to assist Gen-Probe in obtaining FDA regulatory clearance for transplant diagnostic and other assays to be run on Life’s 3500 Dx Genetic Analyzer.
Under terms of the agreement, Gen-Probe will commercialize future sequencing-based diagnostic assays and fragment analysis-based human diagnostic genetic tests to be used on the Life Technologies 3500 Dx Series Genetic Analyzers. The 3500 Dx analyzers are capillary electrophoresis sequencing instruments, designed for analyzing human DNA or RNA to detect genetic changes that potentially may be associated with disease presence or susceptibility.
In March 2011, Life Technologies announced plans to pursue 510(k) clearance of the 3500 Dx system for use in combination with its SeCore ® kits for HLA typing, following completion of clinical trials currently underway. The 3500 Dx instrument is CE-marked for in vitro diagnostic use in Europe and is also available in Australia, India, New Zealand, Singapore, and Taiwan. Several of Gen-Probe’s ELUCIGENE genetic testing products are currently CE-marked for use with the system in Europe.
“This agreement leverages the strengths of both companies – LIFE’s gold standard CE sequencing technology and Gen-Probe’s experience in the diagnostics market,” said Todd Laird, Vice President and General Manager of Life Technologies Fragment and Sequence Genomics Division.
It is expected that 510(k) clearance will allow the 3500 Dx instrument to be marketed for sequencing purposes. The instrument features a novel consumables design that incorporates the ability to track information with radio frequency identification (RFID) tags, new optical and thermal sub-systems, and redesigned data collection and analysis software, creating a cost-effective method for sample analyses.
The agreement also provides rights to Gen-Probe for several of Life Technologies’ proprietary technologies, and calls for the companies to collaborate on FDA 510(k) submissions for assays developed under the agreement.
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 @LIFECorporation and on Facebook.
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