EU Launches Project to Improve In-Vitro Diagnos...
QIAGEN led-consortium to develop standards for patient sample
processing in order to facilitate the discovery and prediction of
diseases
Venlo, The Netherlands, January 12, 2009 - The European Union
launched a new research project targeting to expand the potentials
and utility of in-vitro diagnostics through the creation of new
standards for the collection, handling and processing of blood,
tissue, tumor and other sample materials. Under the 7th Framework
Programme, the European Commission approved the initiative's funding
and scope to develop corresponding standards, tools and quality
assurance schemes. The SPIDIA project ("Standardisation and
improvement of generic Pre-analytical tools and procedures for
In-vitro DIAgnostics") is scheduled to run for four years and has a
total budget of over 13 million Euros. The consortium, consisting of
a total of 16 companies and research institutions from 11 countries,
will be led by QIAGEN (Nasdaq: QGEN; Frankfurt, Prime Standard: QIA),
Europe's largest biotechnology company and a global leader in
molecular sample and assay technologies.
The project has been set up to standardize the pre-analytical
handling of patient samples used for in-vitro (in glass) diagnosis of
human diseases. Such diagnostic procedures are performed in
laboratories, hospitals and doctors' practices. In in-vitro
diagnostics, the collection, handling and processing of sample
materials are regarded as particularly critical procedures, as the
reliability of the subsequent analysis and therefore the
meaningfulness of the diagnosis are vitally dependent upon the
integrity of the sample. For example, the molecular profiles of
target molecules may change or disappear without proper treatment or
stabilisation during collection, transportation or storage of the
sample - thus making improperly handled samples useless for
subsequent analysis.
"Far too many differing sample processing methods, which then lead to
different results, are still being used", said Arnd Hoeveler, Head of
Unit "Health biotechnology" in the Directorate "Health" of the
Commission's Directorate-General for Research. "This variance hampers
the comparability and reproducibility of results and reduces the
meaningfulness of the analyses. More standardized guidelines and
quality assurance schemes will help to introduce new and better
diagnostic methods, which will benefit all European patients."
It is believed that molecular diagnostics, in which DNA and RNA are
the molecules of interest, will play a particularly vital role in
future healthcare in Europe. These so-called molecular diagnostic
methods allow earlier and more reliable information about the status
of a disease than conventional methods. Molecular diagnostics can
also facilitate predictions concerning the future courses of diseases
and lead to individualised therapeutic measures. They are therefore
viewed as fundamental to the emergence of the new era of personalised
medicine.
"QIAGEN welcomes this initiative and considers it extremely important
in paving the way for a significant expansion of the potential of
in-vitro diagnostics", said Peer M. Schatz, CEO of QIAGEN. "The
ongoing standardization of the collection, handling and processing of
relevant samples will speed up the dissemination of new in-vitro
diagnostic methods. With its support of this project, the Commission
is providing strong leadership in emphasizing the importance of these
processes in general and molecular diagnostics and their role as
cornerstones of future healthcare in Europe in particular."
SPIDIA is designed as an integrative project and further along the
road, the intention of the project is also to develop standards for
the other in-vitro diagnostics steps, i.e. the actual analysis. At
the end of the four years a proposal for quality controls and uniform
guidelines for the execution of the entire in-vitro diagnostic
process should be in place. The network anticipates to share first
results after two years.
About SPIDIA
The SPIDIA project (Standardisation and improvement of generic
Pre-analytical tools and procedures for In-vitro DIAgnostics) is an
amalgamation of 16 members from 11 countries, including companies
such as TATAA BIOCENTER AB, PreAnalytiX GmbH (a QIAGEN/BD Company),
DIAGENIC ASA, Aros Applied Biotechnology A/S, Dako Denmark A/S,
ACIES, ImmunID Technologies, academic partners such as universities
and research institutes in Munich, Florence, Graz, Prague and
Rotterdam. The International Agency for Research and Cancer and the
European Standardisation Committee are also members of the project,
which is being led by QIAGEN GmbH in Hilden. This is also the
location of the contact office. The project is being sponsored as
part of the European Union's 7th framework programme. More
information is available at www.spidia.eu.
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 3,000 people in over 30
locations worldwide. Further information about QIAGEN can be found at
www.qiagen.com.
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Contact:
Dr. Solveigh Mähler Dr. Thomas Theuringer
Director Investor Relations Associate Director Public
QIAGEN N.V. Relations
+49 2103 29 11710 QIAGEN GmbH
e-mail: +49 2103 29 11826
solveigh.maehler@qiagen.com email:
thomas.theuringer@qiagen.com
Albert F. Fleury
Investor Relations North America
QIAGEN N.V.
+1 301 944 7028
e-mail: albert.fleury@qiagen.com
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