Global biotechnology tools company -
Life Technologies Corporation
) 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
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
) MAGE-A3 cancer immunotherapy and has an assay development
partnership with Gen-Probe, which was recently acquired by
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
The company now carries a Zacks Rank #3 (Hold). A medical
device stock worth a look is
). The stock carries a Zacks Rank #1 (Strong Buy).
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