QIAGEN Receives FDA Clearances for Rotor-Gene Q MDx Instrument and Compatible Influenza A/B Assay
HILDEN, Germany, and GERMANTOWN, Maryland, April 17, 2012 /PRNewswire/ –
- Both products receive 510(k) clearance for in vitro diagnostic use in the U.S.
- Rotor-Gene Q MDx platform offers automated real-time PCR testing in molecular in vitro diagnostic applications
- Influenza A/B assay the first QIAGEN test to receive 510(k)clearance for IVD use on Rotor-Gene Q MDx platform in the U.S., paving the way for further test menu expansion
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that the
U.S. Food and Drug Administration (FDA) has granted two 510(k) clearances for its
real-time PCR (polymerase chain reaction) instrument Rotor-Gene Q MDx and a compatible
test for the detection of Influenza A/B, the artus Infl A/B RG RT-PCR Kit, for in vitro
diagnostic use (IVD).
“The FDA clearances for the Rotor-Gene Q MDx along with the first assay for use on
this system represent an important milestone for QIAGEN,” said Peer M. Schatz, Chief
Executive Officer of QIAGEN N.V.” The various Rotor-Gene Q models marketed by QIAGEN are
not only an integral part of our revolutionary lab automation platform QIAsymphony RGQ,
but are also among the most widely used stand-alone molecular detection platforms
worldwide. Outside the U.S., our customers already have access to a broad portfolio of
molecular diagnostic tests for use on these platforms. The FDA clearances now pave the way
to make this market-leading assay portfolio available to clinical laboratories in the U.S.
The Rotor-Gene Q MDx instrument is an automated molecular detection platform based on
real-time PCR technology. The system is intended for in vitro diagnostic use with FDA
cleared or approved nucleic acid tests in clinical laboratories. The platform uses a
unique centrifugal rotary design to amplify and quantify DNA molecules, enabling a
near-perfect well-to-well thermal and optical uniformity and a fast data acquisition rate.
These qualities make the Rotor-Gene Q MDxa preferred choice for IVD molecular diagnostic
The artus Infl A/B RG RT-PCR Kit is a multiplex real-time PCR IVD test intended to aid
in differential diagnosis through qualitative detection and identification of Influenza A
and B viral infections in nasopharyngeal swab samples using the Rotor-Gene Q MDx
instrument. Influenza is one of the most frequent respiratory diseases. Since many
flu-like symptoms may be caused by other pathogens, testing for influenza viruses helps to
reduce the inappropriate use of antibiotics and to determine whether antiviral therapy
would be appropriate. According to the Centers for Disease Control and Prevention, about
250,000 influenza tests are performed in U.S. laboratories during the annual flu season.
Former versions of the artus Infl A/B RG RT-PCR kit were among the most widely used assays
in the influenza epidemics 2005/2006 and 2009/2010 worldwide.
The artus Infl A/B RG RT-PCR Kit is the first in a series of IVD molecular diagnostics
that QIAGEN plans to launch on the Rotor-Gene Q MDx platform in the U.S. Several other
PCR-based assays are either under regulatory review or are being prepared for submission
to the FDA – for instance, proposed companion diagnostics based on mutations in the KRAS
gene to guide colorectal cancer treatments and on mutations in the EGFR gene to guide lung
cancer treatments, as well as an assay for detection of cytomegalovirus (CMV).
Outside the U.S., the various models of Rotor-Gene Q high-performance real-time PCR
cyclers already gained registrations as medical device in many key markets including the
European Union, China, Japan, Korea, Brazil, Australia and Russia. Subject to regulatory
approvals in different regions and countries of the world, QIAGEN markets various
Rotor-Gene Q models as a standalone IVD instrument or as part of the modular IVD platform
QIAsymphony RGQ, which automates entire laboratory workflows from initial sample
processing to the final result.
QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample &
Assay Technologies that are used to transform biological materials into valuable molecular
information. Sample technologies are used to isolate and process DNA, RNA and proteins
from biological samples such as blood or tissue. Assay technologies are then used to make
these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than
500 products around the world, selling both consumable kits and automation systems to
customers through four customer classes: Molecular Diagnostics (human healthcare), Applied
Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and
biotechnology companies) and Academia (life sciences research). As of December 31, 2011,
QIAGEN employed approximately 3,900 people in over 35 locations worldwide. Further
information can be found at http://www.qiagen.com.
Certain of the statements contained in this news release may be considered
forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of
1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended.
To the extent that any of the statements contained herein relating to QIAGEN’s products,
markets, strategy or operating results, including without limitation its expected
operating results, are forward-looking, such statements are based on current expectations
and assumptions that involve a number of uncertainties and risks. Such uncertainties and
risks include, but are not limited to, risks associated with management of growth and
international operations (including the effects of currency fluctuations, regulatory
processes and dependence on logistics), variability of operating results and allocations
between customer classes, the commercial development of markets for our products in
applied testing, personalized healthcare, clinical research, proteomics, women’s
health/HPV testing and nucleic acid-based molecular diagnostics; changing relationships
with customers, suppliers and strategic partners; competition; rapid or unexpected changes
in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due
to general economic conditions, the level and timing of customers’ funding, budgets and
other factors); our ability to obtain regulatory approval of our products; difficulties in
successfully adapting QIAGEN’s products to integrated solutions and producing such
products; the ability of QIAGEN to identify and develop new products and to differentiate
and protect our products from competitors’ products; market acceptance of QIAGEN’s new
products, the consummation of acquisitions, and the integration of acquired technologies
and businesses. For further information, please refer to the discussions in reports that
QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).
Contacts: Public Relations: Dr. Thomas Theuringer Director Public Relations +49-2103-29-11826 +1-240-686-7425 Email: email@example.com http://www.twitter.com/qiagen http://www.qiagen.com/about/press Investor Relations: John Gilardi VP Corporate Communications +49-2103-29-11711 +1-301-240-686-2222 Albert F. Fleury Investor Relations North America +1-301-944-7028 Email: firstname.lastname@example.org http://www.qiagen.com/about/investorrelation
SOURCE QIAGEN N.V.