QIAGEN gains rights to genomic biomarkers for lung, brain and other cancers to expand its pipeline of companion diagnostics
- Licenses diagnostic rights for ALK (anaplastic lymphoma kinase) gene, a promising target for novel class of lung cancer drugs, from Insight Genetics, Inc.
- Acquires rights for diagnosis of IDH1/IDH2 mutations in brain gliomas, acute myelogenous leukemia and other cancers from Personal Genome Diagnostics Inc.
- Diagnostic tests for these biomarkers are expected to be developed and commercialized for use as prognostic tools or as companion diagnostics for new anticancer drugs
QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced two agreements with U.S. biotech companies to acquire worldwide exclusive rights to biomarkers that are expected to play an important role in personalized treatment of various cancers.
QIAGEN has entered into a strategic co-development partnership and licensing agreement with Insight Genetics, Inc. of Nashville, Tennessee, for a genetic test covering the ALK (anaplastic lymphoma kinase) biomarker, a promising target for a novel class of lung cancer drugs.
Through a separate agreement between its 89% subsidiary Ipsogen and Personal Genome Diagnostics Inc., of Baltimore, Maryland, QIAGEN has also acquired worldwide exclusive rights to testing for mutations of the IDH1 and IDH2 genes - which are believed to play a role in brain cancers, acute myelogenous leukemia (AML) and certain other malignancies.
"These two new agreements add to our significant activities in further expanding our broad portfolio of novel and relevant biomarkers that can drive personalized healthcare. QIAGEN is a global leader in the emerging market for companion diagnostics, which are increasingly guiding the treatment decisions in various cancers and other diseases," said Peer Schatz, Chief Executive Officer of QIAGEN. "The two agreements announced today add to our portfolio the ALK biomarker, which is being targeted by several pharmaceutical companies for new anti-cancer treatments, as well as the IDH1/IDH2 biomarker, which is currently playing a critical role in intense R&D activity for candidate medicines targeting brain gliomas and other cancers. In addition to providing these assays to researchers, we intend to develop companion diagnostics to make these biomarkers available in combination with new medicines."
The strategic co-development partnership and licensing agreement with Insight Genetics, a molecular diagnostics company focused on enhancing personalized cancer care, gives QIAGEN worldwide exclusive rights to Insight Genetics' diagnostic IP to the ALK gene. The companies will collaborate in the development of a corresponding test that can be clinically validated and marketed by QIAGEN as a companion diagnostic. Mutations of ALK are implicated in non-small cell lung cancer (NSCLC) and other cancers, and several anticancer compounds known as ALK inhibitors, are in clinical trials. One ALK inhibitor has been approved by the FDA, but it is currently paired with a diagnostic method that can be technically challenging and costly.
Through its 89% subsidiary Ipsogen S.A., QIAGEN gained exclusive rights to diagnostics for IDH1/IDH2 mutations from Personal Genome Diagnostics Inc., a biotechnology company founded by experts in cancer genetics. In 2008, those scientists reported the discovery of mutations in IDH1/IDH2 in connection with brain cancers, including early-stage and late-stage gliomas. Subsequent studies have implicated IDH1/IDH2 mutations in AML and other cancers. Assays that detect and measure the biomarker could prove valuable for research into these diseases, differential diagnosis, and development of companion diagnostics.
QIAGEN is the world's leading independent provider of molecular technologies for personalized healthcare, currently offering more than 30 commercial assays including tests for the biomarkers KRAS, EGFR, BRAF and PI3K. QIAGEN is expanding its presence in the personalized healthcare field through regulatory submissions in the U.S., Japan and other markets as well as through targeted acquisitions. QIAGEN has already accumulated a deep portfolio of proprietary markers that have the potential to play a significant role in a broad range of personalized healthcare applications. QIAGEN is considered a leading company in terms of research and development partnerships for companion diagnostics with pharmaceutical companies.
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, and to expected growth of QIAGEN's business in Taiwan and Asia in particular, 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).
About QIAGEN N.V.
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 bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay 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 digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. As of September 30, 2011, QIAGEN employed nearly 3,800 people in over 35 locations worldwide. Further information about QIAGEN can be found at www.qiagen.com.