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Building out Medical Sciences Business, Life Tech 'Locks Down' Clinical Workflow on PGM

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As it builds out its medical sciences business with multiple tuck-in acquisitions and partnerships, Life Technologies is continuing to make inroads in the clinical sequencing market with its Ion Torrent PGM platform, company officials said on a conference call this week to discuss 2012 third quarter earnings.

Around 20 percent to 30 percent of PGM users are clinical customers, chief operating officer Mark Stevenson said during the call. Similarly, around 20 percent to 30 percent of orders for the company's recently launched Ion Proton system are from clinical customers.

The company has previously said that it would submit the PGM to the US Food and Drug Administration for 510(k) clearance this year. On the call, Stevenson said that the company is continuing to develop the protocol and reagents for the submission.

Stevenson said that the company has been focusing on improvements to read lengths and sample prep to ensure the system it submits has the optimal read length and accuracy. The company is "about to lock that down soon," after which, it will submit its 510(k) application, he added. He did not provide further details about which chip or read lengths will ultimately be submitted to the FDA.

Additionally, company officials highlighted Life Tech's efforts to expand its medical sciences business with acquisitions and partnerships.

In October, Life acquired cancer bioinformatics firm Compendia, which has a cloud-based tool called Oncomine to integrate high-throughput cancer data, including data from next-generation sequencing, to correlate mutational profiles with drug response and clinical outcomes.

On the call, Life's CEO Greg Lucier said that the Compendia workflow can be integrated with the Ion Reporter software to give Ion Torrent customers "robust bioinformatics solutions for early-phase clinical research."

The company also formed two partnerships this quarter that will be aimed at developing diagnostic content. One was a partnership with Bristol Myers Squibb to develop companion diagnostics in the field of oncology. As the company said previously, its medical sciences business will span multiple technology platforms, including next-gen sequencing, qPCR, CE sequencing, and fluorescence in situ hybridization (CSN 8/1/2012). As such, the agreement with Bristol Myers will include a "broad range" of the company's platforms.

"The pharmaceutical industry is increasingly turning its focus to discovering and delivering targeted, personalized medicines," said Lucier. And, as these drugs hit the market, "there will be a growing need for diagnostics."

The second agreement the company inked this quarter was a supply and licensing deal with diagnostics firm VelaDx to develop oncology and virology diagnostics on the Ion Torrent PGM platform (CSN 10/10/2012).

VelaDx currently markets clinical diagnostic PCR-based tests based on an automated workflow system dubbed Sentosa. The companies will combine VelaDx's Sentosa workflow with the PGM, Lucier said. Additionally, VelaDx will pursue FDA clearance for these sequencing-based tests.

Lucier said Life is continuing to look for additional partners with which to develop diagnostic tests on the PGM platform.

"The success of the clinical PGM platform, as is the case for most diagnostic platforms, will rely in part of the existence of a menu of tests that have high value in the market," he said.

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