QIAGEN and Pathway Diagnostics Sign Agreement to Address Biomarker Development Needs in Pharma
Unique Offering Will Enhance Clinical Development and Validation of Biomarkers in Global R&D Programs and Clinical Trials
Venlo, The Netherlands, January 8, 2007 - QIAGEN N.V. (Nasdaq: QGEN, Frankfurt, Prime Standard: QIA), a leading provider of molecular diagnostics products and the world's premier supplier of solutions for preanalytical sample preparation, and Pathway Diagnostics Corporation (Malibu, CA), a pioneer in biomarker development and testing services for the pharmaceutical industry, today announced a co-marketing partnership. The new partnership allows customers in the biotechnology and pharmaceutical industries to leverage QIAGEN's sample and assay technology platforms in combination with Pathway Diagnostics' clinical development and testing service capabilities. Under the partnership, QIAGEN‘s global pharmaceutical sales channel and resource network will develop project opportunities which can be addressed together with the service capabilities of Pathway Diagnostics.
The pharmaceutical industry is currently accelerating its focus on the co-development and co-validation of biomarker assays with therapeutics. These biomarker assays are intended to improve drug development efficiency by improving patient selection and clinical trial outcomes, accelerating time-to-market cycles for new drugs, and reducing clinical trial costs. In some cases, biomarker development may lead to companion diagnostic products that will be utilized as a prerequisite for therapeutic intervention.
QIAGEN currently offers a broad portfolio of sample and assay technologies that are considered standards in biomarker development and routinely used in the pharmaceutical industry. Pathway Diagnostics is a leading service provider for biomarker development. QIAGEN and Pathway Diagnostics expect to have a significant impact on critical needs emerging in pharma to establish the clinical utility of new biomarkers through comprehensive assay development, sample-to-result qualification and clinical validation of genetic, pharmacogenomic, metabolomic, and toxicogenomic biomarkers in cancer, infectious disease, central nervous system disorders, cardiovascular disease, and other drug development programs in the pharmaceutical industry.
"We are very pleased to enter into this partnership with Pathway Diagnostics and believe that this offers a novel and unique value proposition for our customers in the pharmaceutical and biotechnology industries," said Peer Schatz, QIAGEN's Chief Executive Officer. " Pathway and QIAGEN share the vision that biomarker development and testing is at the forefront of accelerating drug development and providing clinical diagnostic value leading to improved patient care and associated therapeutic intervention. Pathway's biomarker expertise and QIAGEN's global reach will allow our shared vision to be realized. "
"Pathway is pleased to be teaming with QIAGEN, a worldwide leader of sample and assay technologies for the pharmaceutical industry, "said Walter Narajowski, President and CEO of Pathway Diagnostics. "QIAGEN's global reach in pharma, and its ability to provide technology and industry leading solutions along the complete continuum from research through drug development into clinical diagnostics, combined with Pathway Diagnostics' broad experience and infrastructure for performance of clinical assay services is a winning combination to accelerate translational and personalized medicine initiatives for the pharmaceutical industry. "
Biomarkers are today widely adopted in pharmaceutical drug development. Biomarkers are unique molecular, nucleic acid or protein, signatures associated with specific cellular processes, biochemical pathways, or cell surface receptors. Biomarkers can provide specific indication of patient profiles, disease or disease processes, and are a basis for the rapidly emerging fields of pharmacogenomics, metabolomics, and toxicogenomics in modern drug development. The promise of these fields lies in the potential to help identify sources of inter-individual variability in drug response; this information can make it possible to create so- called "learning clinical trials" and selective, population-based therapies. These drug development strategies have the intent of maximizing effectiveness, minimizing risk and thereby increasing scientific and financial outcomes. The strategic application of biomarkers may have significant influence on a successful drug development program.
QIAGEN N.V., a Netherlands holding company, is a leading provider of innovative technologies and products for pre-analytical sample preparation and molecular diagnostics solutions. QIAGEN has developed a comprehensive portfolio of more than 500 proprietary, consumable products and automated solutions for sample collection, and nucleic acid and protein handling, separation, and purification. QIAGEN also supplies diagnostic kits, tests, and assays for human and veterinary molecular diagnostics. The company's products are sold to academic research markets, and to leading pharmaceutical and biotechnology companies; as well as to diagnostics laboratories. QIAGEN also provides purification and testing solutions to applied testing markets: such as forensics, animal or food testing, and pharmaceutical process control.
QIAGEN employs more than 1,800 people worldwide. QIAGEN products are sold through a dedicated sales force and a global network of distributors in more than 40 countries.
Further information about QIAGEN can be found at http://www.qiagen.com/.
About Pathway Diagnostics Corporation:
Pathway Diagnostics is a biomarker development company focused on the novel application of patent-protected biomarkers to address unmet medical needs and improve patient management. The company combines unique expertise in biomarker development and application across multiple disease disciplines, with a broad range of advanced technology platforms, a full-service and licensed laboratory for clinical trials, and extensive industry relationships for early access to intellectual property. Pathway has assembled a multi-disciplinary team with the expertise to identify, optimize and validate biomarker assays for all phases of drug development and clinical diagnostic applications. These assets make Pathway a valuable partner for pharmaceutical and biotechnology companies as well as clinical diagnostic test providers.
Further information about Pathway Diagnostics can be found at http://www.pathwaydx.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 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 acquisitions of 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).
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