QIAGEN Introduces CE-marked Molecular Assay for the Cancer Biomarker K-ras

Pyrosequencing-based molecular test detects and profiles genetic mutations to predict responses to EGFR inhibitor therapies in colorectal cancer patients

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QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of a new test to determine mutations of the K-ras gene. The K-ras gene is mutated in between 35 percent and 45 percent of metastatic colorectal cancer (CRC) patients. Studies have shown that K-ras testing can better define which CRC patients will benefit from treatment with epidermal growth factor receptor (EGFR) inhibiting monoclonal antibodies, such as Amgen's Vectibix® (panitumumab) and Imclone/Bristol-Myers Squibb's Erbitux® (cetuximab).

QIAGEN's new "PyroMark Q24 K-ras Assay-Kit" is CE-marked for use in second-line treatment of metastatic CRC together with Erbitux or Vectibix and will be available near the beginning of 2009. QIAGEN intends to launch this assay for in vitro diagnostic use in the United States as well. QIAGEN's new "PyroMark Q24 K-ras Assay-Kit" is able to detect all major and minor known mutations in the K-ras codons 12, 13 and 61, and, in addition, allows the discovery of new mutations as well. This assay is the first molecular assay QIAGEN is launching based on Pyrosequencing, a fundamental technology for short-length, high resolution sequence analysis and quantification. QIAGEN acquired the technology and the associated business in October 2008 from Biotage.

"The design and performance of this assay demonstrates the great potential which Pyrosequencing has for molecular testing in research and molecular diagnostics and underscores the value of this technology as an integral part of our assay and detection portfolio", says Peer Schatz, CEO of QIAGEN. "Unlike other technologies routinely used in molecular diagnostics (such as PCR), Pyrosequencing reads the actual target sequence. While PCR can only detect known sequences, Pyrosequencing can detect all known and unknown genetic variations in all DNA target regions in which mutations occur - and this all at very attractive prices, with built in quality control, in multiplex formats and even from the most challenging starting materials such as fixed tissue."

The market for K-ras testing has seen strong momentum over the last months. A number of recently published studies, including a large multinational prospective study conducted by the Belgian University in Leuven, suggested that the K-ras mutation status is a prognostic biomarker predicting the outcome of EGFR therapies. In this study, approximately 40% of all CRC-patients had mutated K-ras genes. The trial data indicated that such patients will not benefit from, and in some cases even experience negative reactions to EGFR antibodies, while patients without specific mutations are likely to benefit from this drug treatment.

In response to these studies, European regulators adopted the indication for Vectibix (panitumumab) to include only patients whose tumours carry the unmutated K-ras gene. Earlier this month, the U.S. National Comprehensive Cancer Network (NCCN) issued new guidelines for treatment of CRC which recommended that only patients with tumours characterized by the unmutated K-ras gene shall be treated with EGFR drugs. This organization of 21 cancer centres furthermore recommended that oncologists should generally determine the K-ras gene status of all patients diagnosed with CRC prior to any treatment.

For the future, experts also expect the inclusion of molecular diagnostic tests for K-ras testing as companion tests for EGFR treatment of other cancers, such as lung adenocarcinomas or thyroid cancer. "Routine K-ras testing can help to define the most effective treatment for cancer patients", Mr. Schatz added. "Personalized medicine will without doubt further shape the future of healthcare. It enables physicians to customize therapies for effectiveness and efficiency, it greatly reduces healthcare costs and, most importantly, it can contribute to the avoidance of unnecessary or even harmful treatments for patients suffering from serious diseases". QIAGEN already offers a large portfolio of pharmacogenetic sample and assay technologies which includes, subject to regulatory approval in various countries, molecular tests related to transplantation and therapies related to cancer and infectious diseases.

About K-ras:

K-ras is an oncogene which plays a crucial role for the development of tumours. Mutations in the ras family of proto-oncogenes (comprising H-ras, N-ras and K-ras) are very common, being found in up to 30% of all human tumors. Due to a mutation of the K-ras gene, cancer cells continue to grow and divide. Mutant K-ras is present in approximately 35-45 percent of colorectal cancers, in 15-50 percent of lung cancers and in 72-90 percent of pancreatic cancers. The mutations have been localized in various DNA sections, in codons 12, 13, 59 and 61. Several recently published studies have shown that the mutation status can be a prognostic marker for treatment with EGFR antibodies such as Erbitux® and Vectibix®. By knowing a patient's K-ras mutation status, oncologists are able to identify whether a patient can benefit from treatment with these antibodies and can individualize cancer therapy for these patients.

Safe harbor statement

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).
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