QIAGEN Adds to Pipeline of Personalized Healthcare Diagnostics Through Agreements for Promising New Biomarkers

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Jan 07, 2013, 04:00 ET

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."

Rheumatoid arthritis

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 Gründerfonds 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.

Lung cancer

QIAGEN has agreed to license exclusive worldwide rights from Insight Genetics Inc., a molecular diagnostics 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.

Colorectal cancer

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^® 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.

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 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 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).