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Life Tech Sees Clinical Promise for NGS Panels, Exomes; Says Multiple Platforms to Drive Dx Strategy

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Life Technologies is fleshing out a strategy to build out its medical sciences business across multiple technology platforms, including next-gen sequencing, qPCR, CE sequencing, and fluorescent in situ hybridization, leveraging its installed base of around 7,500 genetic analysis instruments.

The company plans to develop assays in five key areas — oncology, inherited disease, neurological disorders, transplant diagnostics, and infectious diseases, Ronnie Andrews, president of Life Tech's medical sciences division, said during a conference call discussing the company's second-quarter earnings.

Andrews provided a bit more detail on the company's molecular diagnostics strategy, which it broadly outlined in its 2012 first-quarter earnings call (CSN 4/25/2012). The strategy will include next-gen sequencing, in the near term on the Ion Torrent PGM and eventually on the Proton. The PGM in particular is a "technology that's ready for clinical development," Andrews said.

Life Tech's CEO Greg Lucier added that when it comes to NGS, the company's focus on gene panels and exomes, rather than whole human genomes, puts it in a better position to capture the clinical market than some of its competitors.

When doing whole genome sequencing for clinical purposes, the bioinformatics is a "huge stumbling block," said Lucier. "What you're seeing in the clinic — and we have designed our instrument with a bull's eye on this — is panels and to some extent exomes," he said.

Lucier also reiterated Life Tech's plans to file for 510(k) clearance with the US Food and Drug Administration for the Ion Torrent PGM.

Andrews cited two recent examples of how Life Tech's medical sciences division will grow: a planned collaboration with two children's hospitals to develop protocols on the Ion Proton (CSN 7/27/2012), and the "tuck-in” acquisitions of Navigenics and Pinpoint Genomics that it closed within the past month.

Regarding the collaborations with the Hospital for Sick Children in Toronto and Boston Children's Hospital, Life Tech will "gain rights to share tools, methods, and protocols [with] other customers to accelerate adoption, and add value to the Ion platform," he said.

Meantime, the acquisition of Navigenics, which closed in mid-July, gives Life Tech access to the company's CLIA-certified laboratory and physician portal. Andrews said that the acquisition was a "means to an end" that will allow it to take products it has developed in a research setting and validate them for a clinical setting, as well as take proprietary products developed by academic groups elsewhere and market them through a clinical laboratory.

He said that over the next year or so Life Tech will embark on a number of collaborations and will seek to license additional assays or products to further this goal.

Andrews did not give specifics about future tests, but said that oncology was an especially promising area. He has previously said that qPCR will be its primary testing platform at first, but that it will eventually move some of these to the Ion Torrent platform (CSN 7/18/2012).

The Navigenics acquisition will also enable collaborations with pharmaceutical companies to develop companion diagnostic tests, he added.

Additionally, he said that the physician portal and Navigenics' curated database will be extremely useful in enabling Ion Torrent sequence data to be combined with phenotypic data to come up with outcomes that are relevant to decision making.

"The bioinformatics challenge in the genomics world is great, but I think we're on top of it," he said.

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