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QIAGEN Unveils Diagnostic Assay in the EU to Detect Genetic Variation Causing Adverse Reactions in AIDS Patients

HLA-B*5701 biomarker indicates risk for severe adverse reactions to Abacavir / Experts expect more tests for similar markers in the future

Venlo, The Netherlands – August 19, 2008 – QIAGEN (Nasdaq: QGEN; Frankfurt Prime Standard: QIA) today announced that it has introduced a new molecular diagnostic test to type the HLA-B*5701 allele, a genetic variation in the Human Leucocyte Antigen (HLA) system.

HIV patients carrying the HLA-B*5701 marker have a 60% higher risk to develop hypersensitivity reaction (HSR) to Abacavir, which is a component of several widely marketed drugs inhibiting the reverse transcriptase of the HI virus. HSR is a serious and sometimes even fatal multi-organ syndrome that manifests i.e. in fever, respiratory or constitutional symptoms.

On July 24, the U.S. Food and Drug Administration (FDA) has advised healthcare professionals that all HIV patients should be screened for HLA-B*5701 before initiating treatment with drugs containing Abacavir. Institutions in other countries such as Germany issued similar warnings. The regulatory bodies therewith responded to results from a new study published in the New England Journal of Medicine earlier this year. The PREDICT1-1-Study carried out at the Royal Perth Hospital and Murdoch University, Perth, Australia among 1956 patients from 19 countries found that HLA-B*5701 is a major biomarker for the HSR.

“The screening for HLA-B*5701 prior to Abacavir treatment allows the identification of patients likely to develop HSR. Using HLA-B*5701 tests as a companion diagnostic with the drug Abacavir therefore helps to better protect HIV-infected patients in treatment from severe additional suffering”, says Magnus Ingelman-Sundberg, Professor and Head of the Section of Pharmacogenetics at the Karolinska Institute in Stockholm and responsible for the commentary on the PREDICT1-study in the New England Journal of Medicine. “The combination of diagnostics and therapeutics is a key approach to eliminating risks of side effects and therefore increasing the efficacy of drugs”. Dr Ingelman-Sundberg expects more tests for pharmacogenetic markers to be introduced in the near future, including tests for HLA alleles, which are believed to play an important role in patients’ responses to a number of drugs. “CarbamazepineÓ, for instance, which is prescribed for treatment of epilepsy, is more likely to cause dangerous or even fatal skin reaction in Asian patients carrying the HLA-B*1502 allele,” Dr Ingelman-Sundberg adds.

“Our new test is another great example for the advent of molecular diagnostic tests, which can be used to assess the efficacy of drugs. This trend holds great promises for the future. Enabling doctors to customize therapies based on molecular tests which create molecular profiles of patients or diseases ultimately leads to more medical innovation, cost efficiency and – most importantly – to better and safer treatment of patients”, says Peer Schatz, CEO of QIAGEN. “So far, we have only seen the tip of the pharmacogenomic and companion diagnostic icebergs. At QIAGEN we are proud of the roles that our sample and assay technologies and molecular diagnostics franchise contribute to bringing the vision of personalized medicine to reality.”

Albert Fleury

Associate Director Investor Relations North America

phone: +1 301 944 7028

email: [email protected]

URL: http://www.QIAGEN.com

Sample & Assay Technologies

www.qiagen.com

QIAGEN GmbH, Hilden

Commercial Register Düsseldorf (HRB 45822)

Managing Directors: Peer M. Schatz, Roland Sackers,

Bernd Uder, Dr. Joachim Schorr