QIAGEN Adds to Pipeline of Personalized Healthcare Diagnostics Through Agreements for Promising New Biomarkers
HILDEN, Germany and GERMANTOWN, Maryland, January 7, 2013 /PRNewswire/ –
- QIAGEN invests in new companion diagnostic being developed by Drug Response Dx that aims to predict efficacy of TNF-alpha inhibitors in rheumatoid arthritis patients - Rights to RET, ROS1 and DEPDC1 biomarkers gained from Insight Genetics offer promise as companion diagnostics in lung cancer - New tests from Inserm for mutations of HSP110 gene target diagnostic data on specific types of colorectal cancer, complementing other companion diagnostics
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced three
separate agreements that add multiple biomarkers to QIAGEN’s deep development pipeline of
diagnostics for Personalized Healthcare applications to guide treatments with various
medicines based on a patient’s genomic information.
QIAGEN intends to develop new diagnostics to guide treatment decisions (including
companion diagnostics paired with medicines) based on these biomarkers for use in
therapeutic areas such as rheumatoid arthritis, lung cancer and colorectal cancer. Most of
these assays will be designed to run on the QIAsymphony RGQ modular laboratory workflow
automation system as well as QIAGEN’s next-generation sequencing workflows currently in
development. By guiding treatment decisions for specific therapies in individual patients,
the use of these biomarkers as companion diagnostics can help improve patient outcomes and
better utilize healthcare resources.
“These new agreements add further depth to our extensive development portfolio of
biomarkers with potential to provide valuable diagnostic information as well as
personalized guidance for treatment decisions. The opportunity to create a new, improved
paradigm in the important and vast field of rheumatoid arthritis is very exciting, and the
other agreements further deepen our pipeline in oncology,” said Peer M. Schatz, Chief
Executive Officer of QIAGEN. “QIAGEN’s global leadership in co-developing Personalized
Healthcare solutions in partnership with pharmaceutical and biotechnology companies has
become a key growth driver for our business. Our diagnostics are delivering molecular
information to transform medical care for a wide range of diseases.”
QIAGEN has made a strategic equity investment in Drug Response Dx GmbH with the option
to obtain worldwide rights to biomarkers for evaluation of rheumatoid arthritis (RA)
patients to guide treatment with TNF-alpha inhibitors, which are widely prescribed for
treatment of RA.
Rheumatoid arthritis is a chronic inflammatory disease that affects 70 million
patients worldwide. Therapy with TNF-alpha inhibitors is successful in approximately
60-70% of RA patients, but treatment failure does not become apparent for about six
months. A companion diagnostic to predict which RA patients are likely to respond to
TNF-alpha inhibitors would improve quality of life for patients through tailored and
earlier use of the most effective drugs, while also decreasing costs due to failed
treatments. This test would be highly complementary in the RA marketplace with
QuantiFERON-TB Gold, QIAGEN’s gold standard test for detection of latent tuberculosis
(TB), since the prescribing information for many TNF-alpha inhibitors and other biological
medicines requires testing for latent TB before use of the medicines.
Drug Response Dx, based in Hennigsdorf, Germany, is being financed at this stage by
QIAGEN and High-Tech Gruenderfonds GmbH, a German investor in early-stage companies and a
co-founder of Drug Response Dx, which has developed proprietary RA biomarkers based on
technology licensed from Max-Planck-Innovation.
QIAGEN has agreed to license exclusive worldwide rights from Insight Genetics Inc., a
company in Nashville, Tennessee, for the RET, ROS1 and DEPDC1 biomarkers for use in
non-small cell lung cancer (NSCLC), the most common form of lung cancer.
The agreement with Insight addresses a significant unmet need in the diagnosis and
treatment of NSCLC. Collectively, RET, ROS1 and DEPDC1 mutations are estimated to be
present in up to about one in ten of all NSCLC cases, but so far there are no
regulatory-approved commercial tests to reliably and efficiently identify these
biomarkers. Therapies targeting RET and ROS1 have shown good efficacy in clinical trials,
so companion diagnostics have the potential to help identify patients who carry these
mutations and could benefit from new targeted cancer therapies.
Previously, QIAGEN and Insight entered a licensing and co-development partnership for
companion diagnostics focusing on the ALK gene, which several pharmaceutical companies are
targeting for new anticancer treatments. The development of the EM4-ALK assay for use on
the QIAsymphony automation system is progressing well. Mutations of ALK are implicated in
NSCLC and other malignancies, and several compounds known as ALK inhibitors are in
clinical trials; one ALK inhibitor already is on the market.
QIAGEN Marseille (QIAGEN’s subsidiary previously known as Ipsogen) has licensed
exclusive worldwide rights to a biomarker for mutations of the HSP110 gene, which allows
for identification of specific types of colorectal cancer, from InsermTransfert, the
technology transfer arm of the French National Institute of Health and Medical Research
(Inserm) in Paris. QIAGEN intends to develop the biomarkers into a diagnostic test for
routine use in the diagnostic work-up of colorectal cancer patients.
Diagnosing HSP110 mutations holds promise for enabling doctors to identify so-called
microsatellite instability (MSI), which occurs in about 15% of all colorectal cancers.
Patients with MSI have a more favorable outcome. On the other hand, about one-third of
these patients with MSI have Lynch syndrome, an inherited form of colorectal cancer that
is linked to a higher risk of developing a second cancer. The detection of this mutation
is expected to help in assessing the MSI phenotype of colorectal cancer. The HSP110
biomarker will complement QIAGEN’s therascreen tests that identify genetic mutations of
the KRAS and BRAF genes in colorectal cancer patients.
Excellence in Personalized Healthcare
QIAGEN is a leading partner globally in developing and validating companion
diagnostics to guide the selection of medicines in treating cancer and other diseases. In
July 2012, QIAGEN received FDA approval for the therascreen(R) KRAS RGQ PCR
Kit as a companion diagnostic in patients with metastatic colorectal cancer. The U.S.
rollout of therascreen KRAS builds on a strong global leadership position including
successes in Japan, where regulators approved the therascreen KRAS and EGFR
kits in 2011, and in Europe, where QIAGEN offers 10 CE-marked assays for personalized
healthcare applications. QIAGEN has more than 15 projects under way to co-develop and
market companion diagnostics with leading pharmaceutical and biotechnology companies.
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
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 September 30, 2012,
QIAGEN employed approximately 4,000 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
, 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).
Public Relations: Dr. Thomas Theuringer Director Public Relations +49-2103-29-11826 +1-240-686-7425 Email: firstname.lastname@example.org
Investor Relations: John Gilardi VP Corporate Communications +49-2103-29-11711 +1-240-686-2222
Peter Vozzo Director, Global Investor Relations +1-240-751-7400 Email: email@example.com
SOURCE Qiagen N.V.