|
ROCHE DIAGNOSTICS AND QIAGEN PARTNER TO DEVELOP AND COMMERCIALIZE
AN INTEGRATED DIAGNOSTIC SYSTEM FOR HEPATITIS AND HIV PCR TESTING
Pleasanton, California; Indianapolis, Indiana and Venlo, the Netherlands
- May 7, 2002: Roche Molecular Systems, Inc. (RMS), a business area
of Roche Diagnostics and Roche Diagnostics Corporation (RDC), the
US sales and marketing arm of Roche Diagnostics, and QIAGEN GmbH,
a wholly owned subsidiary of QIAGEN N.V. (Nasadaq: QGENF, Frankfurt:
QIA) today announced that they have entered into a development,
manufacturing and supply agreement. This partnership has the goal
of developing and distributing a customized integrated diagnostic
system for use in the nucleic acid sample preparation, detection
and quantification of the Hepatitis B, Hepatitis C and Human Immunodeficiency
(HIV-1) viruses based on Roche's patented polymerase chain reaction
(PCR) technology.
The customized system will incorporate modified versions of automated
sample preparation modules from QIAGEN , based on the soon to be
launched QIAGEN MDx BioRobot, into a system branded as the TaqPrep.
The TaqPrep will be integrated with a modified version of Roche's
COBAS TaqManÔ Analyzer, designed to target amplification using
real time PCR and nucleic acid extraction methods for the detection
of infectious agents that cause various diseases. Roche Diagnostics
Corporation will distribute these integrated systems in the United
States to large reference laboratories processing greater than 200
PCR Hepatitis B and C and HIV test requests per day.
The parties expect that utilizing QIAGEN's proprietary silica membrane
technologies, extraction of both DNA and RNA can be performed on
a fully automated, walk-away basis, processing up to 96 samples
in only a few hours. Following nucleic acid sample extraction, processed
samples will be transferred onto Roche's COBAS TaqMan platform for
amplification and detection. With Roche's patented technology, amplification
and detection of nucleic acid occurs simultaneously in a single
reaction tube and can be monitored in "real time," allowing
for more rapid and reliable detection of viral pathogens. Specially
designed hardware and software will also be utilized for positive
sample tracking, integrating the entire testing process for laboratories,
with a result turn-around time of less than six hours.
A fully integrated and customized system combining sample preparation
and analysis is critical for high throughput laboratories. Large
reference laboratories have demanding sample throughput, workflow
and turnaround time requirements in order to process such high volume
PCR testing.
"We have been steadfastly working with our large reference
laboratory customers here in the U.S. to fully understand their
PCR testing needs and requirements," states Martin Madaus,
President and CEO of Roche Diagnostics Corporation. "We believe
we have truly differentiated ourselves within the industry by seeking
to provide them with the first integrated real time PCR in vitro
diagnostics solution to meet these unique needs," he continues.
Roche's PCR technology has already revolutionized the monitoring
and treatment of HIV/AIDS and Hepatitis patients with its AMPLICORÒ
in vitro diagnostic kits for these critical diseases. To date, Roche
remains the only company able to offer PCR products approved by
the U.S. Food and Drug Administration in both of these testing arenas.
"We are very proud that Roche has selected our nucleic acid
purification platform as a front end to their new high throughput,
real-time amplification and detection TaqMan analyzer," said
Dr. Helge Bastian, Vice President, Global Strategic Marketing at
QIAGEN. "Efficient extraction and purification of target nucleic
acids is key to the sensitivity and reliability of nucleic acid
testing using methods such as PCR and poses significant and technological
challenges in clinical settings. QIAGEN's technology and market
leadership in nucleic acid purification in molecular diagnostics
is adding substantial value to the development of standardized and
highly efficient solutions in this emerging and rapidly growing
market."
About QIAGEN N.V.
QIAGEN N.V., a Netherlands holding company with subsidiaries in
Germany, the United States, Japan, the United Kingdom, Switzerland,
France, Italy, Australia and Canada, believes it is the world's
leading provider of innovative enabling technologies and products
for the separation, purification and handling of nucleic acids.
The Company has developed a comprehensive portfolio of more than
320 proprietary, consumable products for nucleic acid separation,
purification and handling, nucleic acid amplification, as well as
automated instrumentation, synthetic nucleic acid products and related
services. QIAGEN's products are sold in more than 42 countries throughout
the world to academic research markets and to leading pharmaceutical
and biotechnology companies. In addition, the Company is positioning
its products for sale into developing commercial markets, including
DNA sequencing and genomics, nucleic acid-based molecular diagnostics,
and genetic vaccination and gene therapy. QIAGEN employs over 1,600
people worldwide. Further information on QIAGEN can be found at
http://www.QIAGEN.com.
About Roche and Roche Diagnostics
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-oriented healthcare groups in the fields of pharmaceuticals,
diagnostics and vitamins. Roche's products and services address
prevention, diagnosis and treatment of diseases, thus enhancing
well-being and quality of life. Roche's Diagnostics Division, the
world leader in in vitro diagnostics with a uniquely broad product
portfolio, supplies a wide array of innovative testing products
and services to researchers, physicians, patients, hospitals and
laboratories worldwide. Roche Molecular Systems, Inc., a business
area of Roche Diagnostics, has made the polymerase chain reaction
(PCR) the leading nucleic acid amplification technology (NAT) in
the world. PCR technology allows minute amounts of genetic material
to be amplified into billions of copies in just a few hours, thereby
facilitating detection of the DNA or RNA of pathogenic organisms
even before antibodies to these organisms are formed. Roche Diagnostics
Corporation is the North American headquarters for the diagnostics
business of the company. Roche Diagnostics' website is located at
http://www.roche-diagnostics.com.
For more information please contact:
RMS
Paula Evangelista
Director Public Relations
Phone: 925.730.8374
Paula.evangelista@roche.com
QIAGEN
Peer M. Schatz
Chief Financial Officer
Phone: +49.2103.2911.702
p.schatz@de.QIAGEN.com
QIAGEN
Dr. Solveigh Mahler
Manager Investor Relations
Phone: +49.2103.2911.710
s.maehler@de.QIAGEN.com
|