QIAGEN Introduces CE-marked Molecular Assay for...
Pyrosequencing-based molecular test detects and profiles genetic
mutations to predict responses to EGFR inhibitor therapies in
colorectal cancer patients
Venlo, The Netherlands - November 10, 2008 - QIAGEN N.V. (NASDAQ:
QGEN; Frankfurt Prime Standard: QIA) today announced the launch of a
new test to determine mutations of the K-ras gene. The K-ras gene is
mutated in between 35 percent and 45 percent of metastatic colorectal
cancer (CRC) patients. Studies have shown that K-ras testing can
better define which CRC patients will benefit from treatment with
epidermal growth factor receptor (EGFR) inhibiting monoclonal
antibodies, such as Amgen's Vectibix® (panitumumab) and
Imclone/Bristol-Myers Squibb's Erbitux® (cetuximab).
QIAGEN's new "PyroMark Q24 K-ras Assay-Kit" is CE-marked for use in
second-line treatment of metastatic CRC together with Erbitux or
Vectibix and will be available near the beginning of 2009. QIAGEN
intends to launch this assay for in vitro diagnostic use in the
United States as well. QIAGEN's new "PyroMark Q24 K-ras Assay-Kit" is
able to detect all major and minor known mutations in the K-ras
codons 12, 13 and 61, and, in addition, allows the discovery of new
mutations as well. This assay is the first molecular assay QIAGEN is
launching based on Pyrosequencing, a fundamental technology for
short-length, high resolution sequence analysis and quantification.
QIAGEN acquired the technology and the associated business in October
2008 from Biotage.
"The design and performance of this assay demonstrates the great
potential which Pyrosequencing has for molecular testing in research
and molecular diagnostics and underscores the value of this
technology as an integral part of our assay and detection portfolio",
says Peer Schatz, CEO of QIAGEN. "Unlike other technologies routinely
used in molecular diagnostics (such as PCR), Pyrosequencing reads the
actual target sequence. While PCR can only detect known sequences,
Pyrosequencing can detect all known and unknown genetic variations in
all DNA target regions in which mutations occur - and this all at
very attractive prices, with built in quality control, in multiplex
formats and even from the most challenging starting materials such as
fixed tissue."
The market for K-ras testing has seen strong momentum over the last
months. A number of recently published studies, including a large
multinational prospective study conducted by the Belgian University
in Leuven, suggested that the K-ras mutation status is a prognostic
biomarker predicting the outcome of EGFR therapies. In this study,
approximately 40% of all CRC-patients had mutated K-ras genes. The
trial data indicated that such patients will not benefit from, and in
some cases even experience negative reactions to EGFR antibodies,
while patients without specific mutations are likely to benefit from
this drug treatment.
In response to these studies, European regulators adopted the
indication for Vectibix (panitumumab) to include only patients whose
tumours carry the unmutated K-ras gene. Earlier this month, the U.S.
National Comprehensive Cancer Network (NCCN) issued new guidelines
for treatment of CRC which recommended that only patients with
tumours characterized by the unmutated K-ras gene shall be treated
with EGFR drugs. This organization of 21 cancer centres furthermore
recommended that oncologists should generally determine the K-ras
gene status of all patients diagnosed with CRC prior to any
treatment.
For the future, experts also expect the inclusion of molecular
diagnostic tests for K-ras testing as companion tests for EGFR
treatment of other cancers, such as lung adenocarcinomas or thyroid
cancer. "Routine K-ras testing can help to define the most effective
treatment for cancer patients", Mr. Schatz added. "Personalized
medicine will without doubt further shape the future of healthcare.
It enables physicians to customize therapies for effectiveness and
efficiency, it greatly reduces healthcare costs and, most
importantly, it can contribute to the avoidance of unnecessary or
even harmful treatments for patients suffering from serious
diseases". QIAGEN already offers a large portfolio of pharmacogenetic
sample and assay technologies which includes, subject to regulatory
approval in various countries, molecular tests related to
transplantation and therapies related to cancer and infectious
diseases.
About K-ras:
K-ras is an oncogene which plays a crucial role for the development
of tumours. Mutations in the ras family of proto-oncogenes
(comprising H-ras, N-ras and K-ras) are very common, being found in
up to 30% of all human tumors. Due to a mutation of the K-ras gene,
cancer cells continue to grow and divide. Mutant K-ras is present in
approximately 35-45 percent of colorectal cancers, in 15-50 percent
of lung cancers and in 72-90 percent of pancreatic cancers. The
mutations have been localized in various DNA sections, in codons 12,
13, 59 and 61. Several recently published studies have shown that the
mutation status can be a prognostic marker for treatment with EGFR
antibodies such as Erbitux® and Vectibix®. By knowing a patient's
K-ras mutation status, oncologists are able to identify whether a
patient can benefit from treatment with these antibodies and can
individualize cancer therapy for these patients.
About QIAGEN:
QIAGEN N.V., a Netherlands holding company, is the
leading global provider of sample and assay technologies. Sample
technologies are used to isolate and process DNA, RNA and proteins
from biological samples such as blood or tissue. Assay technologies
are used to make such isolated biomolecules visible. QIAGEN has
developed and markets more than 500 consumable products as well as
automated solutions for such consumables. The company provides its
products to molecular diagnostics laboratories, academic researchers,
pharmaceutical and biotechnology companies, and applied
testing customers for purposes such as forensics, animal or food
testing and pharmaceutical process control. QIAGEN's assay
technologies include one of the broadest panels of molecular
diagnostic tests available worldwide. This panel includes the only
FDA-approved test for human papillomavirus (HPV), the primary cause
of cervical cancer. QIAGEN employs more than 2,900 people in over 30
locations worldwide. Further information about QIAGEN can be found at
www.qiagen.com.
SAFE HARBOR STATEMENT
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 are
forward-looking, such statements are based on current expectations
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 and risks of dependency on
logistics), variability of operating results, the commercial
development of the applied testing markets, clinical research markets
and proteomics markets, nucleic acid-based molecular diagnostics
market, and genetic vaccination and gene therapy markets,
competition, rapid or unexpected changes in technologies,
fluctuations in demand for QIAGEN's, products (including fluctuations
due to the level and timing of customers' funding, budgets, and other
factors), our ability to obtain regulatory approval of our infectious
disease panels, 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 its products from competitors' products, market
acceptance of QIAGEN's new products and the integration of acquired
technologies and businesses. For further information, refer to the
discussions in reports that QIAGEN has filed with, or furnished to,
the U.S. Securities and Exchange Commission (SEC).
Contacts:
Dr. Solveigh Mähler Dr. Thomas Theuringer
Director Investor Relations Associate Director Public
QIAGEN N.V. Relations
+49 2103 29 11710 QIAGEN GmbH
e-mail: +49-2103-29-11826
solveigh.maehler@qiagen.com email:
thomas.theuringer@qiagen.com
Albert F. Fleury
Director Corporate Finance and
Investor Relations North America
QIAGEN Gaithersburg, Inc.
+1 301 944 7028
e-mail: albert.fleury@qiagen.com
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.