Life Technologies Corp has signed a collaborative agreement with San Diego-based Gen-Probe Inc 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, VP 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.
