QIAGEN Reaches Milestone With 75 Million Deliveries of HPV Tests, Announces Strategy Update for QIAensemble ProgramBy Qiagen N.v., PRNE
Saturday, May 7, 2011
Growing U.S. market penetration and other regions' adoption of HPV testing in cervical cancer screening programs drive global deliveries of digene HC2 HPV Test
HILDEN, Germany and GERMANTOWN, Maryland, May 8, 2011 - QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA)
today announced a milestone with the delivery of more than 75 million digene
HPV tests worldwide - the gold standard in screening women for human
papillomavirus, which is the primary cause of cervical cancer - since the
first U.S. regulatory approval of this important molecular diagnostics test
The announcement was made at the start of two international
medical society meetings, EUROGIN in Portugal and Clinical Virology Symposium
(CVS) in Florida, where QIAGEN highlighted its role as a major driver in the
adoption of molecular screening solutions for disease prevention based on the
success of its digene HC2 HPV Test. It was the first molecular diagnostics
test to receive FDA approval to determine the need for colposcopy/biopsy
referral for women with borderline abnormal cytology results and for
co-testing with cytology to screen women age 30 and over to assess risk of
cervical cancer caused by persistent unresolved HPV infection.
The value of HPV testing is increasingly recognized in
treatment guidelines around the world, particularly in the U.S. where nearly
45% of women who receive the traditional Pap test also undergo HPV screening.
Many countries have established or are evaluating co-testing, primary
screening or reflex HPV screening as a cornerstone of cervical cancer
prevention programs. With about 500,000 new cases and 300,000 related deaths
annually around the world, cervical cancer is the second most frequent cancer
in women. Early detection has been proven to reduce the burden of this
disease, as cervical cancer can be effectively treated if found in its early
QIAGEN also announced a comprehensive update for the
QIAensemble suite of next-generation automation platforms, which was
originally targeted for use in disease prevention:
- Reaffirming QIAensemble Evolution, a program that is being
launched in 2011 to add modules to the current Rapid Capture System in order
to create best-in-class automation of test processing.
- Making significant changes to the QIAensemble Revolution
program for development of next-generation automation systems, creating a new
dimension of screening utility by offering multiple detection technologies on
one platform and access to broader testing menus.
"The delivery of 75 million digene HPV tests is a great
success and marks a milestone in the struggle to eliminate cervical cancer,"
said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. "We continue to
offer the 'gold standard' in HPV screening, proven by overwhelming clinical
data from more than 300 studies involving one million women. This level of
validation is unmatched by any rivals. The updates to our QIAensemble
programs will help us further expand our leadership in molecular testing and
provide effective automation solutions to our customers."
The QIAensemble programs were placed under review in mid-2010
in light of changes in customer demands for certain specifications in their
automation profile and test menus, technical and commercial aspects of this
program and the overall needs of customers involved in molecular diagnostics.
Data from recent clinical studies involving competitor products also
reaffirmed that no test to date has matched or exceeded the performance and
reliability of the digene HC2 HPV Test.
QIAensemble Evolution for near-term, best-in-class automation
For QIAensemble Evolution, QIAGEN is finalizing the
implementation of the original plan, which is expected to for the first time
in this industry create a fully automated workflow from liquid cytology
sample vials to final test results. This workflow will significantly reduce
manual steps and hands-on time required to prepare HPV test samples for
analysis, with the aim of providing best-in-class workflow automation.
Elements of the QIAensemble Evolution program include:
- Sample Technology automation
- QIAGEN is on track to launch the QIAensemble Decapper Unit
in 2011, an enhancement that will automatically unseal liquid cytology sample
vials to extract liquids for sample preparation, one of the most burdensome
steps in the workflow. No other company currently offers an automated
solution for this step.
- QIAGEN also plans to offer sample preparation solutions
based on the proven and reliable QIAsymphony platform to further automate the
process between the decapping of liquid cytology vials and sample analysis.
The QIAsymphony system received a CE-IVD mark in Europe in January 2011 for
processing of liquid-based cytology media. A clinical trial to support a U.S.
FDA PMA Supplement submission for the automated processing of liquid cytology
samples with the QIAsymphony system is set to begin in 2011, and a regulatory
submission could occur later this year.
- Assay Technology automation
- The well-established Rapid Capture System, which has a
throughput capacity of up to 350 samples in an eight-hour shift, will remain
an integral component of the QIAensemble program and will be harmonized
within this suite of instruments.
QIAensemble Revolution to provide next-generation platforms
For QIAensemble Revolution, a comprehensive update of the
development plan is being implemented that addresses the review's outcomes
with the goal of providing high-throughput capacity and advanced automation.
Elements of the QIAensemble Revolution program include:
- Sample Technology automation
- The QIAensemble Decapper Unit will be a component of the
- Proven technologies from the successful QIAsymphony instrumentation
family will be integrated into the new QIAensemble ST ("sample technology")
system. These technologies will be formatted into a high-throughput platform
capable of processing more than 1,000 samples in an eight-hour shift and
supporting multiple detection technologies, particularly Hybrid Capture and
real-time PCR. Overall, three automated sample processing configurations are
planned to address different customer requirements: QIAsymphony will be
offered for low-to-medium-throughput (up to 300 samples per shift);
QIAensemble ST will be offered for significantly higher volumes; and tailored
solutions of QIAensemble system modules are planned to be offered to
customers requiring throughput capacity of far more than 1,000 samples per
- Assay Technology automation
- QIAGEN is very advanced in the development of QIAensemble
AT, an assay processing system that builds on earlier QIAensemble designs.
The digene HC2 HPV Test will be migrated to the first version of this system.
Recent large-scale clinical studies have reaffirmed the critical role of the
digene HC2 HPV Test in cervical disease prevention. The digene HC2 HPV Test
already competes with many rival tests in Europe, including products set to
enter the U.S. market in 2011. A next-generation HPV assay remains in
development with a focus on disease progression and other markers that could
be included in a future clinical trial of such a new testing panel.
QIAensemble AT is expected to receive a CE-IVD mark in Europe in 2012, while
a submission for U.S. regulatory approval is planned for 2013.
- QIAensemble AT is expected to more than double the capacity
of the current Rapid Capture System and to exceed all current competitor
offerings. Among the benefits are integrated detection, fully automated
workflow, overnight processing and integration of the central control unit
that maintains all patient information in one system.
Benefits of the updated QIAensemble strategy
By building upon proven core components from the QIAsymphony
platform, QIAGEN will enhance compatibility of QIAensemble and QIAsymphony,
allowing the migration of tests within and between the platforms. This design
feature also will enable customers to consolidate workflows on a standardized
system supporting multiple detection technologies, including real-time PCR
and hybrid capture.
As part of the updated strategy, QIAGEN also decided to expand
ongoing menu development plans, which under the new platform strategy design
can be migrated and shared across the QIAensemble and QIAsymphony families.
The expanded menu plan includes a new assay development program for Chlamydia
and Gonorrhea (CT/NG) based on real-time PCR. This test will be initially
launched on the QIAsymphony, and then to be migrated to the QIAensemble
platform. This assay has been prioritized over the ongoing development
program involving isothermal amplification detection technology. QIAGEN
expects to submit the new assay in 2012 for regulatory approval in Europe and
shortly thereafter in the U.S.
"We believe the updated QIAensemble program offers many
benefits to our customers," Mr. Schatz said. "For the QIAensemble Evolution
program, development is moving along as initially planned, and it is clear
that its specifications are unrivaled. By adding novel and flexible sample
technology, we can quickly offer best-in-class workflow automation. For the
QIAensemble Revolution program, our comprehensive review showed that the
original strategy concentrated significant resource investments and risks
into narrow market segments, and we have made appropriate updates. Our new
QIAensemble strategy substantially derisks the QIAensemble Revolution program
and creates a much broader range of options for customer coverage. With this
updated QIAensemble Revolution program, we will offer our customers the
best-in-class assay on a best-in-class automation solution, adding value with
increased throughput and standardized workflows supporting multiple detection
options. The fact that no competitor test has matched the level of clinical
validation available for the digene HC2 HPV Test further underscores the
benefits of quickly migrating this assay onto highest-performance automation.
Very importantly, our decision to share instrument components will make
QIAsymphony and QIAensemble more compatible to share assays, which will
accelerate our menu creation and help position QIAGEN to achieve even
stronger leadership in molecular diagnostics."
QIAGEN N.V., a Netherlands holding company, is the leading
global provider of Sample & 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 these isolated
biomolecules visible. QIAGEN has developed and markets more than 500 sample
and assay products as well as automated solutions for such consumables.
QIAGEN 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 first FDA-approved test for human papillomavirus (HPV),
the primary cause of cervical cancer. QIAGEN employs nearly 3,600 people in
over 30 locations worldwide. Further information about QIAGEN can be found at
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, including without limitation its expected operating
results, are forward-looking, such statements are based on current
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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, regulatory processes and dependence on
logistics), variability of operating results and allocations between business
segments, the commercial development of markets for our products in applied
testing, personalized healthcare, clinical research, proteomics, women's
health/HPV testing and nucleic acid-based molecular diagnostics; changing
relationships with customers, suppliers and strategic partners; competition;
rapid or unexpected changes in technologies; fluctuations in demand for
QIAGEN's products (including fluctuations due to general economic conditions,
the level and timing of customers' funding, budgets and other factors); our
ability to obtain regulatory approval of our products; 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 and protect our products from competitors' products; market
acceptance of QIAGEN's new products and the integration of acquired
technologies and businesses. For further information, please refer to the
discussions in reports that QIAGEN has filed with, or furnished to, the U.S.
Securities and Exchange Commission (SEC).
Information contained in this release is current only as of
the date of the release. With the passage of time, these materials may become
incomplete, obsolete or outdated. QIAGEN has no obligation and assumes no
duty to update these materials.
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