Global biotechnology tools company -
Life Technologies Corporation
) along with
) recently received a 510(k) clearance from the US Food and Drug
Administration ("FDA") to market a new Clostridium (C.) difficile
test of Quidel with Life Technologies' Real-Time PCR Instruments.
These products will be used together to fight hospital-acquired
infections, commonly known as C. difficile bacterial infection
(CDI). This approval complements Life Technologies' ongoing
strategy to expand in the growing diagnostics market with
innovative clinical assays and molecular testing products.
The life-threatening CDIs are commonly observed among the
growing number of elderly population, especially those who are on
a prolonged antibiotic regimen and are on extended hospital
stays. The recent data by the Centers for Disease Control and
Prevention is quite shocking, as it shows that there are as many
as 14,000 deaths annually attributed to CDI in the U.S., costing
around a billion in excess treatment to the national healthcare
system. Thereby, both the companies strongly believe in the need
for a speedy and efficient diagnosis and as a result, are
optimistic about the prospects of their new venture in this field
Recently, Life Technologies undertook various measures to
strengthen its diagnostics franchise. Last September, the company
launched Pervenio Lung RS, a lab-developed test distinguishing
high-risk from low-risk early stage lung cancer patients. Last
month, the company received 510(k) clearance for its 3500 Dx
Genetic Analyzers and SeCore HLA typing kits.
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. Relying 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 entered 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.
Earlier, the company formed a companion diagnostic partnership
) MAGE-A3 cancer immunotherapy and has an assay development
partnership with Gen-Probe.
The company 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). Life Technologies expects a compounded annual growth rate
("CAGR") of 15% for its molecular diagnostic franchise through
The company now carries a Zacks Rank #3 (Hold). Another
medical device stock worth a look is
), which carries a Zacks Rank #2 (Buy).
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