QIAGEN Expands Partnership with Genome Diagnostics for Development of New Tests for Applications in Prevention and Personalized Healthcare
Extended HLA testing portfolio includes products to assess tolerance for Lumiracoxib and for the early detection of inflammatory diseases
Germantown, MD and Hilden, Germany, June 17, 2010 --- QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced that it has entered into an agreement with the Dutch molecular diagnostic component supplier Genome Diagnostics which covers the development and commercialization of 6 new tests until 2011. QIAGEN believes that this collaboration will further expand the Company's testing portfolio for the early detection of diseases and individualized treatment of patients - thereby strengthening QIAGEN's molecular diagnostics offering for applications in prevention and personalized healthcare. Financial details have not been disclosed.
The molecular tests to be developed by Genome Diagnostics target the detection of genetic variations in the so called Human Leukocyte Antigen (HLA) complex. These assays represent the next generation of such tests and are based on QIAGEN's proprietary "Pyrosequencing" and other sequencing technologies. In contrast to other detection methods, Pyrosequencing enables fast, cost effective and accurate analysis of HLA sequences, thereby allowing for direct detection of previously unknown polymorphisms.
Main application areas for the new tests will include prevention and personalized healthcare. These are areas where HLA testing is considered to be increasingly important. Among others, the new product portfolio will include tests for the biomarker HLA DQA1 gene, which is associated with a higher risk for adverse reactions to lumiracoxib, a painkiller marketed by Novartis under the trade name Prexige for treatment of musculoskeletal disorders. Lumiracoxib was withdrawn from Canadian, European and Asian markets after the occurrence of adverse reactions linked to its potential toxic effect on the liver. In early 2010, Novartis announced a possible re-submission of the drug for regulatory approval in combination with an unidentified companion diagnostic which would allow the identification of patients not at risk to develop such adverse reactions, as indicated by their genetic profile. This would make lumiracoxib the first drug which was withdrawn from the market but then re-approved by regulatory authorities in combination with a companion diagnostic test.
Other biomarkers targeted by the new tests include the identification of alleles (DNA sequences of a particular gene) within the groups HLA-B*27 and HLA-B*57. The analysis of these genetic variations in the HLA complex allows for the early identification of patients who are at risk of developing disorders such as Morbus Bechterew and other inflammatory diseases, and is thus considered to be an important part in preventing these disorders. It has also been shown that certain alleles within the groups of HLA-B*27 and HLA-B*57 can give information on the development and progress of infectious diseases such as AIDS.
QIAGEN's portfolio already includes several molecular tests for the DNA-based HLA typing in personalized healthcare, among others a method for the detection of the HLA B*5701 biomarker. This genetic variation is associated with a higher risk for adverse reactions to the AIDS drug Abacavir.
In June 2009, QIAGEN announced that it sold parts of its HLA test portfolio for use in transplantation testing to the Swedish investment company LinkMed and retained rights to market those products in areas such as personalized healthcare. QIAGEN and Genome Diagnostics have been working together since August 2006 on the development and commercialization of new product lines in HLA testing. This collaboration is now being expanded through the development of additional tests.
"Sequence based HLA typing is a fast growing market with significant potential", commented Bob Barrett, Vice President Global Marketing, Molecular Diagnostics at QIAGEN. "Since HLA genes are increasingly associated with a growing number of diseases and the patients' response to drugs, HLA testing allows for the assessment of disease risks and for the development of tailored treatments. That's why the tests we develop as a result of this collaboration make a perfect addition to our molecular diagnostics portfolio for applications in prevention and personalized healthcare."
„We are excited to further strengthen our collaboration with QIAGEN", said Wietse Mulder, Managing Director of Genome Diagnostics. "This allows us to expand our unique expertise in sequencing based HLA typing into the field of companion diagnostics, leading to new innovative IVD assays for the field of preventive and personalized healthcare."
Experts believe that the market for HLA typing in personalized healthcare significantly exceeds the volume of the US$ 170 million large transplantation medicine market, where HLA typing was initially used. QIAGEN has not yet announced timelines for submissions to the FDA and for CE-marking in connection with the tests to be developed under the collaboration.
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. QIAGEN employs more than 3,500 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.
About Genome Diagnostics
Genome Diagnostics B.V. (GenDx) is a Dutch molecular diagnostics company focused on the development, production and sales of innovative assays & analyses software for high resolution tissue typing for transplantation medicine and companion diagnostics. In addition, GenDx offers custom laboratory services for basic and clinical research and stem cell donor registry organisations. GenDx organises world-wide dedicated SBT training courses on a regular basis for personnel of tissue typing laboratories, blood banks and donor registries. GenDx is a spin-off of the University Medical Centre, Utrecht, The Netherlands, and was founded in 2005 by Dr. Erik Rozemuller, Dr. Wietse Mulder and University Medical Centre Utrecht participaties BV.
Since 2006, QIAGEN is an exclusive world-wide distributor of the GenDx SBT reagent line SBTexcellerator®. The software SBTengine® is sold co-exclusively. SBTexcellerator® and SBTengine® are registered trade marks of GenDx. Further information on GenDx can be found at http://www.gendx.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 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).