Forward looking statements

Transcription

1 Update on QIAensemble strategy May 8, Sample & Assay Technologies Forward looking statements Safe Harbor Statement: Certain of the statements contained in this presentation may be considered forwardlooking 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). Regulatory submission strategies outlined in this document may be amended in the future based on the progress of R&D programs as well as the outcome of discussions with various regulatory authorities. Information contained in this presentation is current only as of the date of the presentation. 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 Sample & Assay Technologies

2 Update QIAensemble strategy QIAensemble is a suite of programs for next-generation prevention screening Evolution: Near-term upgrades for best-in-class assay and automated workflow Revolution: New dimension of automation utility and broader menu Program review initiated in mid-2010 Customer demands for automation and menu Competitor HPV test profiles Technical and commercial aspects Customer needs in molecular diagnostics Sample & Assay Technologies Findings of QIAensemble review digene HPV Test remains gold standard for HPV screening Level of validation unmatched by any rivals >75 million tests delivered since U.S. regulatory approval Urgency for next-generation assay reduced development and future trials can now add additional markers Opportunity to offer fully automated solutions with assay Substantial savings in time and cost compared to earlier plans Significant risk reduction Link and QIAensemble programs Share core technologies from Assays can be migrated seamlessly within and across platforms Reduce complexity of development and regulatory strategy Original program carried risks Significant investments into narrow market segments New program addresses same and more needs Sample & Assay Technologies

3 QIAensemble Evolution program Finalizing implementation of original plan Sample Technology automation: Decapper unit to be launched in 2011: Automates initial steps of sample processing, decapping and aliquotting platform for DNA purification and processing CE-IVD for Europe in January 2011 Clinical trial for PMA supplement to start in 2011, possible U.S. regulatory submission by year-end Assay Technology automation: Rapid Capture System: processes up to 350 samples per 8-hours shift Reaffirming commitment to RCS, harmonize instrument into QIAensemble program Sample & Assay Technologies QIAensemble Revolution program Sample Technology automation: Decapper unit to be component of Revolution Proven technologies used in QIAensemble ST Support multiple detection technologies (including Hybrid Capture, real time-pcr) Various solutions to meet customer needs Low to medium: ST High: QIAensemble ST Ultra-high: Tailored QIAensemble ST solutions Assay Technology automation: very advanced in development Builds on earlier QIAensemble designs Migrating gold standard digene HPV test CE-IVD for Europe anticipated in 2012 Submission for U.S. approval planned for 2013 Integrated versions with Hybrid Capture and real-time PCR QIAensemble ST + = QIAensemble Plus Sample & Assay Technologies

4 Platform program: Addressing all needs Hybrid Capture PCR Today Rapid Capture Rotor-Gene Q Future QIAensemble Evolution Rapid Capture Plus QIAensemble Revolution Low-mid High Ultra-high Hybrid Capture and PCR Plus QIAensemble Plus Tailored QIAensemble solutions - Decapper unit Sample Technology Assay Technology Sample & Assay Technologies Platform program: Overview EU launch Throughput QIAensemble Evolution program Assay technology 2011 Mid-high Rapid Capture System QIAensemble Revolution program 2012 Mid-high >2013 Low-mid Plus Real-time PCR >2013 High QIAensemble Plus >2013 Ultra-high Tailored QIAensemble solutions Real-time PCR Screening HPV Genotyping Other All assay technologies * Note: Submissions for U.S. regulatory approvals anticipated to be approximately 6-12 months later than EU launch Sample & Assay Technologies

5 Automation platforms addressing customer needs Mid to high- Unprecedented flexibility Broad menu Academia PoN ESE Prevention U.S. Prevention RoW QIAensemble High Convenience and standardization Narrow menu Pharma Applied Testing Personalized Healthcare Profiling ESE - Portable system PoN - Point of Need Sample & Assay Technologies