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Life Tech Inks CDx Deal with GlaxoSmithKline; Gets China OK for 3500 Dx Genetic Analyzers

NEW YORK (GenomeWeb News) – Life Technologies has forged a partnership with GlaxoSmithKline Biologicals to develop a companion diagnostic test for GSK's candidate cancer immunotherapy, and gained regulatory approval in China for its Applied Biosystems 3500 Dx Genetic Analyzer, it announced separately after the close of the market on Tuesday.

Its deal with GSK calls for the development of a qPCR-based molecular diagnostic assay for identifying patients who would likely benefit from GSK's MAGE-A3 cancer immunotherapy candidate. The multi-gene expression in vitro diagnostic assay will be developed using Life Tech's Taqman Array Card technology.

Under the terms of the deal, Life Tech and GSK — upon the validation of the current Phase III trial on the drug candidate — will develop and commercialize the test for the identification of patients most likely to benefit from MAGE-A3 antigen-specific cancer immunotherapeutics. The companies intend to submit an application to the US Food and Drug Administration seeking premarket approval of the test, Life Tech said.

The MAGE-A3 candidate immunotherapy is undergoing two clinical trials. A Phase III MAGRIT trial, which Life Tech said is the largest lung cancer treatment study ever conducted, is assessing the efficacy and safety of the therapy as an adjuvant treatment in resected non-small cell lung cancer. A Phase III DERMA trial is evaluating the efficacy and safety of the therapy as an adjuvant treatment for patients whose melanoma has invaded lymph nodes.

Financial and other terms of the deal were not disclosed.

Separately, Life Tech announced that the Chinese State Food and Drug Administration approved its 3500 Dx Genetic Analyzer.

The capillary-based Sanger sequencing instruments are for the analysis of human DNA or RNA for detecting genetic changes that may result in disease presence or susceptibility.

The instruments are CE-marked for in vitro diagnostic use in Europe and also are available in Japan, Australia, India, New Zealand, Singapore, and Taiwan. In August, an application was submitted to the FDA for the 3500 Dx, along with Life Tech's Invitrogen SeCore HLA Sequencing System for HLA typing.

In May Life Tech and Gen-Probe announced they would co-develop diagnostic assays for the 3500 Dx platform. Life Tech continues to seek other partners to expand the assay menu, the Carlsbad, Calif.-based firm said.

"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," Siddhartha Kadia, president of Life Tech Greater China, said in a statement.

The 3500 instruments were created specifically with clinicians in mind, the company said, and feature a consumables design with the ability to track information with radio frequency identification tags, new optical and thermal sub-systems, and redesigned data collection and analysis software.

The 3500 Dx Series can run up to 1,100 sequencing or 1,200 genotyping samples per day, depending on the degree of multiplexing, Life Tech said.

The company also reported after the close of the market Tuesday that its third-quarter revenues rose 7 percent year over year.

During a conference call following the release of the earnings, Life Tech Chairman and CEO Greg Lucier called the approval of the 3500 Dx Genetic Analyzer in China "a very important milestone."

He added, "We're putting in place some important partnerships that we'll be announcing that will make that, I think, a real stalwart and an important part of virtually every diagnostic lab in that country."