QIAGEN Unveils Diagnostic Assay in the EU to De...
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."
Today, QIAGEN offers the broadest panel of molecular diagnostic
assays in the world. The portfolio spans, subject to regulatory
approval in various countries, over 120 molecular tests for various
targets, including high resolution, molecular profiling solutions for
HLA-alleles - an area in which QIAGEN has a leading position. The
newly launched test complements a larger personalized medicine
portfolio which includes, subject to regulatory approval in various
countries, molecular tests related to transplantation, cancer and
other therapies.
The new Olerup SSPÓ PCR assay was developed and manufactured by
Olerup SSP AB. It is CE marked in Europe for in vitro diagnostic use
and available for research use in other countries.
About pharmacogenetics and personalized medicine
The field of pharmacogenetics deals with effects of individual gene
variants in response to a given drug and is the fundament for the
concept of "Personalized Medicine". Since patients frequently react
differently to drugs, an effective treatment for one person may have
no impact on someone else, or may even cause adverse reactions. The
main cause of this varying effect is the diversity of humans' genetic
make-up. Understanding the individual differences in the human genome
thus helps physicians select and tailor treatments for their
patients. Leading experts such as the Boston Consulting Group (BCG)
estimate the market potential for personalized medicine for the year
2020 to be 22 billion US$. With a current volume of about 500 million
US$ this would represent an average annual growth (CAGR) of about
37%. According to BCG, the concept of personalized medicine will lead
to significant savings through optimized medication as well as the
detection of previously unknown diseases. This in turn will lead to
considerable progress in prevention, diagnosis and treatment of many
diseases.
About QIAGEN
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 biomolecules visible. QIAGEN has
developed and markets more than 500 consumable 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 only
FDA-approved test for human papillomavirus (HPV), the primary cause
of cervical cancer. QIAGEN employs more than 2,800 people in over 30
locations worldwide. Further information about QIAGEN can be found at
www.qiagen.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
acquisitions of 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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