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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