Press Release

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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Posted 10 November 2008 @ 06:34 pm ET

VENLO, THE NETHERLANDS -- (Marketwire) -- 11/10/08 -- QIAGEN N.V. (NASDAQ: QGEN)(FRANKFURT: QIA) today announced the launch of anew test to determine mutations of the K-ras gene. The K-ras gene ismutated in between 35 percent and 45 percent of metastatic colorectalcancer (CRC) patients. Studies have shown that K-ras testing canbetter define which CRC patients will benefit from treatment withepidermal growth factor receptor (EGFR) inhibiting monoclonalantibodies, such as Amgen's Vectibix® (panitumumab) andImclone/Bristol-Myers Squibb's Erbitux® (cetuximab).

QIAGEN's new "PyroMark Q24 K-ras Assay-Kit" is CE-marked for use insecond-line treatment of metastatic CRC together with Erbitux orVectibix and will be available near the beginning of 2009. QIAGENintends to launch this assay for in vitro diagnostic use in theUnited States as well. QIAGEN's new "PyroMark Q24 K-ras Assay-Kit" isable to detect all major and minor known mutations in the K-rascodons 12, 13 and 61, and, in addition, allows the discovery of newmutations as well. This assay is the first molecular assay QIAGEN islaunching based on Pyrosequencing, a fundamental technology forshort-length, high resolution sequence analysis and quantification.QIAGEN acquired the technology and the associated business in October2008 from Biotage.

"The design and performance of this assay demonstrates the greatpotential which Pyrosequencing has for molecular testing in researchand molecular diagnostics and underscores the value of thistechnology as an integral part of our assay and detection portfolio",says Peer Schatz, CEO of QIAGEN. "Unlike other technologies routinelyused in molecular diagnostics (such as PCR), Pyrosequencing reads theactual target sequence. While PCR can only detect known sequences,Pyrosequencing can detect all known and unknown genetic variations inall DNA target regions in which mutations occur - and this all atvery attractive prices, with built in quality control, in multiplexformats and even from the most challenging starting materials such asfixed tissue."

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

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

For the future, experts also expect the inclusion of moleculardiagnostic tests for K-ras testing as companion tests for EGFRtreatment of other cancers, such as lung adenocarcinomas or thyroidcancer. "Routine K-ras testing can help to define the most effectivetreatment for cancer patients", Mr. Schatz added. "Personalizedmedicine will without doubt further shape the future of healthcare.It enables physicians to customize therapies for effectiveness andefficiency, it greatly reduces healthcare costs and, mostimportantly, it can contribute to the avoidance of unnecessary oreven harmful treatments for patients suffering from seriousdiseases". QIAGEN already offers a large portfolio of pharmacogeneticsample and assay technologies which includes, subject to regulatoryapproval in various countries, molecular tests related totransplantation and therapies related to cancer and infectiousdiseases.

About K-ras:

K-ras is an oncogene which plays a crucial role for the developmentof tumours. Mutations in the ras family of proto-oncogenes(comprising H-ras, N-ras and K-ras) are very common, being found inup 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 inapproximately 35-45 percent of colorectal cancers, in 15-50 percentof lung cancers and in 72-90 percent of pancreatic cancers. Themutations have been localized in various DNA sections, in codons 12,13, 59 and 61. Several recently published studies have shown that themutation status can be a prognostic marker for treatment with EGFRantibodies such as Erbitux® and Vectibix®. By knowing a patient'sK-ras mutation status, oncologists are able to identify whether apatient can benefit from treatment with these antibodies and canindividualize cancer therapy for these patients.

About QIAGEN:

QIAGEN N.V., a Netherlands holding company, is theleading global provider of sample and assay technologies. Sampletechnologies are used to isolate and process DNA, RNA and proteinsfrom biological samples such as blood or tissue. Assay technologiesare used to make such isolated biomolecules visible. QIAGEN hasdeveloped and markets more than 500 consumable products as well asautomated solutions for such consumables. The company provides itsproducts to molecular diagnostics laboratories, academic researchers,pharmaceutical and biotechnology companies, and appliedtesting customers for purposes such as forensics, animal or foodtesting and pharmaceutical process control. QIAGEN's assaytechnologies include one of the broadest panels of moleculardiagnostic tests available worldwide. This panel includes the onlyFDA-approved test for human papillomavirus (HPV), the primary causeof cervical cancer. QIAGEN employs more than 2,900 people in over 30locations worldwide. Further information about QIAGEN can be found atwww.qiagen.com.

SAFE HARBOR STATEMENT

Certain of the statements contained in this news release may beconsidered forward-looking statements within the meaning of Section27A of the U.S. Securities Act of 1933, as amended, and Section 21Eof the U.S. Securities Exchange Act of 1934, as amended. To theextent that any of the statements contained herein relating toQIAGEN's products, markets, strategy or operating results areforward-looking, such statements are based on current expectationsthat involve a number of uncertainties and risks. Such uncertaintiesand risks include, but are not limited to, risks associated withmanagement of growth and international operations (including theeffects of currency fluctuations and risks of dependency onlogistics), variability of operating results, the commercialdevelopment of the applied testing markets, clinical research marketsand proteomics markets, nucleic acid-based molecular diagnosticsmarket, and genetic vaccination and gene therapy markets,competition, rapid or unexpected changes in technologies,fluctuations in demand for QIAGEN's, products (including fluctuationsdue to the level and timing of customers' funding, budgets, and otherfactors), our ability to obtain regulatory approval of our infectiousdisease panels, difficulties in successfully adapting QIAGEN'sproducts to integrated solutions and producing such products, theability of QIAGEN to identify and develop new products and todifferentiate its products from competitors' products, marketacceptance of QIAGEN's new products and the integration of acquiredtechnologies and businesses. For further information, refer to thediscussions in reports that QIAGEN has filed with, or furnished to,the U.S. Securities and Exchange Commission (SEC).

This announcement was originally distributed by Hugin. The issuer issolely responsible for the content of this announcement.

Copyright © Hugin AS 2008. All rights reserved.

Contacts:Dr. Solveigh MählerDirector Investor RelationsQIAGEN N.V.+49 2103 29 11710e-mail:Email ContactAlbert F. FleuryDirector Corporate Finance andInvestor Relations North AmericaQIAGEN Gaithersburg, Inc.+1 301 944 7028e-mail: Email ContactDr. Thomas TheuringerAssociate Director Public RelationsQIAGEN GmbH+49-2103-29-11826email: Email Contact


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