QIAGEN reaches milestone with 75 million deliveries of HPV tests, announces strategy update for QIAensemble program
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
digene HC2 HPV Test remains the "gold standard" in screening women for risk of cervical cancer based on clinical data published in over 300 studies involving one million women
QIAensemble program to develop next-generation automation platforms updated after review of customer needs, competitor profiles, commercial and technical factors
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 in 1999.
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 stages.
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 Revolution program.
- 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 shift.
- 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 http://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, including without limitation its expected operating results, are forward-looking, such statements are based on current expectations and assumptions 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, 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).
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