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Life's Products Gain FDA Approval

Global biotechnology tools company – Life Technologies Corporation (LIFE) recently received 510(k) clearance from the US Food and Drug Administration ("FDA") for its 3500 Dx Genetic Analyzers and SeCore HLA typing kits. This approval complements its ongoing strategy to expand in the growing diagnostics market with innovative clinical assays and molecular testing products.

According to the company, the Applied Biosystems 3500 Dx/3500xL Dx CS2 Genetic Analyzers, Invitrogen SeCore HLA Sequencing Kits and uTYPE Dx HLA Sequence Analysis Software constitute the first 510(k)-cleared, sequence-based system for HLA typing in the U.S. Moreover, the 3500 Dx is the only 510(k)-cleared Sanger sequencer commercially available for the diagnostics market. Banking on the clearance, Life Technologies expects further development of assays using the 3500 Dx.

In addition, the company has plans to submit its next-generation sequencing instrument, the Ion Torrent Personal Genome Machine (PGM), for 510(k) clearance.

Recently, Life Technologies undertook various measures to strengthen its diagnostics franchise. The company recently entered into a Master Development Agreement with Bristol-Myers Squibb for companion diagnostic projects. The collaboration with Bristol-Myers is in line with the company’s strategy of building partnerships with pharmaceutical majors for companion diagnostic development including the participation in early-phase clinical trials.

We are also impressed with the company entering into a license and supply agreement with Singapore-based VelaDx in Oct 2012. VelaDx will develop next generation sequencing-based, in vitro diagnostic tests that will run on Life Technologies’ Ion Personal Genome Machine platform. Earlier, the company formed a companion diagnostic partnership with GlaxoSmithKline's (GSK) MAGE-A3 cancer immunotherapy and has an assay development partnership with Gen-Probe, which was recently acquired by Hologic (HOLX).

The company has also strengthened its diagnostics franchise with three recent tuck-in acquisitions – Compendia Bioscience (Oct 8, 2012), Navigenics (Jul 16, 2012) and Pinpoint Genomics (Jul 25, 2012).The company expects a compounded annual growth rate ("CAGR") of 15% for its molecular diagnostic franchise through 2016.

The company now carries a Zacks Rank #3 (Hold). A medical device stock worth a look is ResMed Inc. (RMD). The stock carries a Zacks Rank #1 (Strong Buy).

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