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Life Tech, Gen-Probe to Collaborate on FDA Clearance for Dx Assays on CE Sequencer

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Life Technologies will help Gen-Probe obtain FDA clearance for transplant diagnostic and other assays that will run on its 3500 Dx Genetic Analyzer capillary electrophoresis sequencer, the company said last week.

Under the agreement, Gen-Probe will commercialize future diagnostic tests — based on DNA sequencing or DNA fragment analysis — that will run on Life Tech's 3500 Dx Genetic Analyzer.

In addition, Gen-Probe has the right to commercialize its Elucigene genetic disease tests for use with the 3500 Dx Genetic Analyzer in the US. Several Elucigene genetic tests are already CE-marked for use with the instrument 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 fragment and sequence genomics at Life Tech, in a statement.

Life Tech said in March that it is conducting clinical trials to prove the safety and effectiveness of sequence-based typing on the 3500 Dx Genetic Analyzer and plans to obtain 510(k) clearance for the system for use with its SeCore kits for HLA typing (CSN 3/22/2011).

The 3500 Dx is CE-marked for in vitro diagnostic use in Europe, and is also available in Australia, India, New Zealand, Singapore, and Taiwan.

Gen-Probe is also collaborating with Pacific Biosciences on developing sequencing-based diagnostics. Last year, the company invested $50 million in PacBio, and the firms said they plan to co-develop a system for use in diagnostics that is based on PacBio's single-molecule real-time sequencing technology (IS 6/22/2010).

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