FDA Approves Qiagen's IVD Products - Analyst Blog
April 19 2012 - 8:00AM
Zacks
Molecular diagnostics solutions
provider, Qiagen (QGEN) recently received 510(k)
clearances from the US Food and Drug Administration (FDA) for two
of its products for in vitro diagnostic use (IVD) in the US. Of the
two products, Rotor-Gene Q MDx provides a real-time polymerase
chain reaction (PCR) testing in molecular IVD applications
while the artus Infl A/B RG RT-PCR Kit is a compatible test on
Rotor-Gene platform to detect Influenza A/B.
Qiagen is currently witnessing
higher demand for its wide-ranging Rotor-Gene Q models, the
integral part of lab automation platform QIAsymphony RGQ, which is
widely accepted in clinical laboratories worldwide along with other
molecular detection platforms. Although clinical laboratories
outside the US already had access to the company’s molecular
diagnostic tests portfolio for use on these platforms, US customers
did not have any such offer. The Influenza A/B assay is the first
test kit of Qiagen to receive FDA nod and is expected to open the
door forfurther expansion in diagnostic test kits.
As per the recent data published by
the US Centers for Disease Control and Prevention, 50,000 influenza
tests are performed in the US laboratories annually. Thus, the
latest FDA approvals of these IVD products are expected to work in
favor of Qiagen and provide it with solid near-term revenues.
Moreover, these products should fit
well in the company’s product portfolio as the company itself has
been pursuing the development of molecular detection platforms
across the world. This is to note that the earlier versions of the
artus Infl A/B RG RT-PCR kit were widely used across the world
during the 2005/2006 and 2009/2010 influenza epidemics.
Qiagen is facing mounting
competition in the molecular diagnostic space especially from
players like Quest Diagnostics (DGX),
Laboratory Corporation of America Holdings (LH)
and Myriad Genetics (MYGN).
However, we remain encouraged by
Qiagen’s focus on strategic initiatives to drive growth and
profitability in the companion diagnostics market. Its innovative
tests in the genomic/esoteric arena with a focus on the high-margin
esoteric testing business are expected to accelerate sales growth
in the next several quarters. Qiagen’s long-term strategy involves
technological advancement and new product introduction that can
hugely enhance its competitive advantage.
Currently, Qiagen retains a Zacks
#3 Rank (short-term Hold). Over the long term, we are Neutral on
the stock, at par with LabCorp and Myriad.
QUEST DIAGNOSTC (DGX): Free Stock Analysis Report
LABORATORY CP (LH): Free Stock Analysis Report
MYRIAD GENETICS (MYGN): Free Stock Analysis Report
QIAGEN NV (QGEN): Free Stock Analysis Report
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