QIAGEN Achieves Personalized Healthcare Milestone with U.S. Approval of Companion Diagnostic for Colorectal Cancer
HILDEN, Germany, and GERMANTOWN, Maryland, July 6, 2012/PRNewswire-FirstCall/ --
- U.S. launch of therascreen(R)KRAS RGQ PCR Kit offers enhanced
approach to
guide treatments for approximately 110,000 patients annually in
U.S. with colorectal
cancer
- First FDA approval of a QIAGEN companion diagnostic marks a
milestone in its
global expansion of rapidly growing Personalized Healthcare
business
- Important cancer assay adds valuable content for an expanding
QIAGEN
automation platform
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today
announced it has received U.S. Food and Drug Administration (FDA)
approval to market the therascreen(R) KRAS RGQ PCR
[http://www.qiagen.com/about/pressreleases/pressreleaseview.aspx?PressReleaseID=355&lang=EN
] Kit (therascreen KRAS test) to provide guidance on the use of
Erbitux(R) (cetuximab) as a treatment in patients with metastatic
colorectal cancer.
The U.S. FDA approval of the KRAS test kit marks a milestone in
QIAGEN's global expansion of its Personalized Healthcare franchise
which includes an industry-leading portfolio of molecular companion
diagnostics to aid treatment decisions in oncology. QIAGEN already
markets a broad range of companion diagnostic tests covering 30
biomarkers in Europe, Asia/Pacific and Japan.
"We are very pleased to receive FDA approval to launch our
therascreen KRAS test in the United States and to play a role in
transforming the care of colorectal cancer patients. This approval
marks an important step for QIAGEN, but also an important step in
Personalized Healthcare, as we are now launching a major molecular
companion diagnostic product in the U.S.," said Peer M. Schatz,
Chief Executive Officer of QIAGEN N.V. "With a growing portfolio of
innovative tests and efficient automation platforms, we are proud
to be helping to make healthcare more effective, providing ways for
payers to more efficiently use healthcare resources and, most
important, making a positive impact on the care of patients."
Pioneering role in Personalized Healthcare
QIAGEN is at the forefront of developing and validating a range of
tests that provide physicians with an individual patient's
molecular information to select the most appropriate medicines.
The entry into the U.S. market with the approval of the first
therascreen test builds on our success in the European market,
where QIAGEN offers 10 CE-marked assays, based either on real-time
PCR technology or on Pyrosequencing. QIAGEN currently markets
therascreen assays in Europe for biomarkers including KRAS, EGFR,
NRAS, BRAF, PI3K, JAK2, MGMT and UGT1A1. In Japan, the therascreen
KRAS and EGFR kits were approved in 2011, solidifying QIAGEN's
leadership position for companion diagnostics in the second biggest
market for Personalized Healthcare. A range of assays and related
Sample & Assay Technologies are also marketed to customers use
during the research and development of new medicines.
QIAGEN is actively expanding its pipeline of Personalized
Healthcare technologies and intends to submit several companion
diagnostics in the coming years for U.S. regulatory approval.
QIAGEN has more than 15 projects under way to co-develop and market
companion diagnostics with leading pharmaceutical and biotech
companies such as Amgen, AstraZeneca, Boehringer Ingelheim,
Bristol-Myers Squibb, Eli Lilly and Company, and Pfizer.
Benefiting patients and providers
Introduction of the therascreen KRAS test provides an FDA-approved
diagnostic available for making treatment decisions for colorectal
cancer patients. Approximately 110,000 colorectal cancer patients
each year in the U.S. could benefit from KRAS testing, according to
QIAGEN estimates.
Studies show the U.S. healthcare system could save more than $600
million annually by avoiding unnecessary use of medicines in
colorectal cancer patients through determinations of their KRAS
status. In metastatic colorectal cancer patients for whom
standalone surgery and chemotherapy are insufficient, treatment
with an epidermal growth factor receptor (EGFR) inhibitor has been
shown to improve overall survival. However, the presence or absence
of KRAS mutations in tumors affects outcomes: Approximately 60% of
patients with mutation-negative (wild-type) KRAS genes may benefit
from anti-EGFR therapy, while 40% whose tumors have KRAS mutations
may not benefit.
The first FDA approval of the therascreen KRAS test pairs this
companion diagnostic with Erbitux(R), a leading EGFR inhibitor
marketed in the U.S. by Bristol-Myers Squibb in partnership with
Eli Lilly and its ImClone Systems unit. According to the U.S.
product information for Erbitux(R), KRAS status evaluation using an
FDA-approved diagnostic test is used to determine treatment, and
the therascreen KRAS kit is currently the only test with this
status. Based on the FDA approval for use in metastatic colorectal
cancer patients, the current annual U.S. market potential for sales
of the therascreen KRAS kit in this indication only is
approximately $20 million.
In contrast to laboratory-developed tests (LDTs), the FDA-approved
therascreen KRAS test gives healthcare providers a fast, consistent
and reliable process to determine optimal treatment for colorectal
cancer patients who are candidates for EGFR-inhibitor therapy. The
therascreen KRAS kit has been shown to have higher sensitivity
(i.e. a lower limit of detection, LOD) for KRAS mutations between
0.8% and 6.4% depending on the assay which is critical to ensuring
reliable and consistent data for treatment decisions.
Following FDA approval, a number of laboratories will begin
offering KRAS status evaluation with the therascreen KRAS test
- Applied Diagnostics, Inc.
- Boyce & Bynum Pathology Laboratories
- Cellnetix Pathology & Laboratories
- Clinical Molecular Oncology Laboratory, The University of Kansas
Medical
Center
- Colorado Molecular Correlates Laboratory (CMOCO), University of
Colorado
- Companion Dx Reference Lab, LLC
- Dahl-Chase Diagnostic Services
- Lab21 Inc.
- Mayo Clinic
For more details and actual status visit
http://www.qiagen.com/therascreen.
Adding value to QIAGEN's automation platforms
In line with QIAGEN's strategy of driving platform success, the
therascreen KRAS test offers laboratories an efficient workflow
based on the Rotor-Gene Q MDx, an automated molecular detection
instrument that uses real-time PCR technology. All other companion
diagnostics in development, as well as a range of other molecular
diagnostic tests, are being developed for U.S. regulatory approval
on the Rotor-Gene Q MDx.
The therascreen KRAS kit is the second assay cleared/approved by
the FDA for use on the Rotor-Gene Q MDx. Earlier in 2012, QIAGEN's
artus Infl A/B RG RT-PCR for the detection of Influenza A/B was
cleared for use on Rotor-Gene Q MDx, with the instrument also
receiving FDA 510(k) clearance at the same time.
About QIAGEN
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 March 31, 2012, 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: pr@qiagen.com
http://www.twitter.com/qiagen
http://www.qiagen.com/about/press
Investor Relations:
John Gilardi
VP Corporate Communications
+49-2103-29-11711
+1-240-686-2222
Albert F. Fleury
Investor Relations North America
+1-301-944-7028
Email: ir@qiagen.com
http://www.qiagen.com/about/investorrelation
Source: QIAGEN N.V.
Posted: July 2012
