QIAGEN – Prevention Update on QIAensemble 2013-04-26آ  QIAGEN Analyst and Investor Day, February 11,

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  • Sample & Assay TechnologiesQIAGEN Analyst and Investor Day, February 11, 2010

    QIAGEN –

    Prevention Update on QIAensemble

    QIAGEN Analyst and Investor Day 2010

    Dr. Jim Godsey

    Chair, Women’s Health Portfolio Team

    Senior Vice President Research & Development North America

    New York, February 11th, 2010

  • Sample & Assay Technologies- 2 -QIAGEN Analyst and Investor Day, February 11, 2010

    What is the QIAensemble strategy for building menu?

    Set the stage for continued market leadership and growth

    Performance Drivers

    .

    Unprecedented levels of throughput

    .

    Leveraging the strengths of the Hybrid Capture Platform

    Leverage the strengths of Hybrid Capture®

    2 technology

    Deliver unprecedented levels of automation and throughput

    Objectives

    QIAGEN’s Next-Generation

    Screening Platform

    Built for the Future MDx Screening (Prevention) Workstation

    Lay foundation for building QIAGEN‘s portfolio of next generation prevention assays

  • Sample & Assay Technologies- 3 -QIAGEN Analyst and Investor Day, February 11, 2010

    High/ultra-high throughput Instrument

    1-2000 tests/shift

    floor model configuration

    High/Ultra-High and Low/Medium Systems

    Low/medium throughput Instrument

    1-

    600 tests/shift

    benchtop configuration

    LIS

    LBC Vials

    Urine

    Vials

    LBC Vials

    Urine Vials

    AnalyticalSample Prep

    Co-collected DCM™ - HPV Urethral Swabs –

    CT/GC

    QIAsymphony™

    SP / QIAensemble™

    3000+

    QIAensemble™

    SP / 2000

    Central Control UnitCentral Control Unit™™ (CCU)(CCU)

    SoftwareSoftware

  • Sample & Assay Technologies- 4 -QIAGEN Analyst and Investor Day, February 11, 2010

    QIAensemble Menu

    Phase 1a Menu (at Launch)

    screening: digene HPV eHC Test

    genotyping: digene HPV eHC 16 18/45 Test

    Phase 1b Menu (at Launch)

    CT/GC

    Group B Strep

    Trichomonas

    Vaginosis

    Phase 2 Menu

    Several high throughput screening assays Cancer prevention (screening) assays Infectious diseases Other , novel screening applications

    QIAensemble

    is

    QIAGEN‘s

    screening

    platform

  • Sample & Assay Technologies- 5 -QIAGEN Analyst and Investor Day, February 11, 2010

    QIAensemble™ Workcell Highest Efficiency in Use of People and Space

    HPV testing-operation footprint reduced by up to 90% Unmatched Throughput: 2000 samples/shift and to >5000 samples/2 shifts

    Repetitive Motions reduced to Zero

    QIAconductorQIAconductor™™ SoftwareSoftware

    LIS

    DCM™** pierceable-

    cap tubes

    (15 plate capacity plate stacker)

    192 DCM™

    capacity loading bay

    2000 results / 8 hrs

    2000 DCM™ / shift

    QIAensemble™ 2000 PreservCyt® & SurePath®*

    vials

    15 plates 8 hrs X 2

    QIAensemble™ SP

    **QIAGEN’s new Digene Co-collection Media

    (DCM™

    )*SurePath is currently under development, and not included in the initial clinical trial protocol

    Wa rni

    ng : Q

    IAe ns

    em ble

    Sy ste

    m in

    Us e.

    Re pe

    titi ve

    M oti

    on Fr

    ee Zo

    ne !

  • Sample & Assay Technologies- 6 -QIAGEN Analyst and Investor Day, February 11, 2010

    The Perfect Decentralized Platform for Hospitals Highest Efficiency in Use of Space

    QIAensemble™ 3000+ (HPV DNA testing and amplified assays)

    (screening)

    QIAsymphony® SP (Industry leader in

    sample prep automation)

    QIAsymphony® Plus (Broad menu of

    Real-time PCR assays for profiling and personalized healthcare )

  • Sample & Assay Technologies- 7 -QIAGEN Analyst and Investor Day, February 11, 2010

    digene® HPV eHC (ensemble Hybrid Capture) Test The Next Gold Standard for HPV Testing

    .

    NextGen Assay Update

    Same outstanding clinical performance of HC2, but now with magnetic beads!

  • Sample & Assay Technologies- 8 -QIAGEN Analyst and Investor Day, February 11, 2010

    Beyond HC2: Assay Improvements in QIAensemble

    Hybrid Capture 2 Current

    digene® HPV eHC Test * New

    digene® HPV eHC 16 18/45 Genotyping Test

    New

    Handling

    4-5 hour assay 2.5-hour assay

    4 ml PreservCyt®

    sample volume per assay 1.5 ml PreservCyt®

    or SurePath™

    sample volume per assay

    2-plate assay (capture plate is one of the reagents) 1-plate assay (inexpensive disposable)

    Performance

    13 high-risk types 15 high-risk types (+ types 66 and 82) 16 18/45 types (greater focus on Adenocarcinoma)

    Acceptable analytical sensitivity Improved analytical sensitivity Matched to digene®

    HPV eHC Test

    Known LR-analytical specificity Significantly improved analytical specificity (no LR x-reactivity) No x-reactivity with other HR or LR types

    Technology

    Complex Ab coating to plates Simple Ab linkage to beads

    Individual bottles Reagent packs (500-

    and 100-test packs) Reagent packs (100-test packs)

    8-hour reagent on-board stability 7-day reagent on-board stability

    digene® HPV eHC Test The New Gold Standard in HPV DNA Testing

  • Sample & Assay Technologies- 9 -QIAGEN Analyst and Investor Day, February 11, 2010

    QIAensemble Evolution Strategy Bringing Tomorrow’s Technology to Customers Today

    QIAensemble Evolution:

    Decapper: Class 1 medical device

    Fully automated sample preparation (PreservCyt® or SurePath™ )

    Genotyping 16/18/45 reagents

    QIAensemble Decapper

    Open Channel Pipettor Class 1Med. Device

    QIAsymphony sp AXpH

    QIAensemble SP hc2

    QIAensemble SP and 2000 QIAensemble Revolution:

    Broad menu high throughput screening system

    Fully automated sample and assay technologies

    HPV testing on novel chemistry, leveraging HC2 Unprecedented throughput and utility

    Broad menu of assays based on amplification

    Today

    Tomorrow

  • Sample & Assay Technologies- 10 -QIAGEN Analyst and Investor Day, February 11, 2010

    Set the stage for continued market leadership and growth

    Performance Drivers

    .

    Unprecedented levels of throughput

    .

    Leveraging the strengths of the Hybrid Capture Platform

    Leverage the strengths of leadership in molecular screening

    Deliver unprecedented levels of automation and throughput

    Objectives

    QIAGEN’s Next-Generation

    Screening Platform

    Building for the Future MDx Screening (Prevention) Workstation

    Lay foundation for building QIAGEN‘s portfolio of next generation prevention assays

  • Sample & Assay Technologies- 11 -QIAGEN Analyst and Investor Day, February 11, 2010

    QIAensemble Strategy - Building Menu in the Future

    The Challenge

    How do you create the Molecular Dx screening workstation of the future that delivers unparalleled clinical performance and throughput for

    Infectious disease Cancer Prevention/Screening Other Prevention/Screening markers

    The Solution

    Successfully integrate isothermal amplification technology into your existing Hybrid Capture®-based testing platform; i.e. the QIAensemble™

    system

    Why isothermal amplification?

    Throughput Analytical sensitivity

  • Sample & Assay Technologies- 12 -QIAGEN Analyst and Investor Day, February 11, 2010

    94°C

    54°C

    72°C

    65oC

    PCR

    QIAensemble Strategy - Building Menu in the Future Helicase-Dependent Amplification (tHDA)

    Isothermal Helicase Dependent Amplification (tHDA)

    Real Time PCR

  • Sample & Assay Technologies- 13 -QIAGEN Analyst and Investor Day, February 11, 2010

    .

    Derived from the QIAensemble™

    400 platform plus

    the following modifications: ■ Plate sealing ■ Modified pipetting volumes (i.e. 10 µl) ■

    Multimode reader (Fluorometer / Luminometer)

    QIAensemble™

    3000+ analyzer will be the only Molecular Dx analyzer to address both of the existing high-volume assays (HPV and CT/GC) and

    provide the capacity for running 10 additional isothermal amplification-based assays on the deck of the same instrument

    .

    CT/GC tHDA-based assay becomes the assay platform

    for rapidly expanding infectious disease menu to include: GBS, Trichomonas & vaginosis panel and beyond

    QIAensemble™

    400 → 3000+

    QIAensemble Strategy – Building Menu in the Future QIAensemble™ 3000+ Series of Instruments

    QIAensemble™

    3000+

  • Sample & Assay Technologies- 14 -QIAGEN Analyst and Investor Day, February 11, 2010

    Best

    Use of

    People

    Best Use of

    Space

    The QIAensemble™ Family of Products True Automation Means Real Value

    Value Creation: Best Use of Space

    Highest throughput per square foot

    90% reduction in footprint of HPV DNA Testing operation

    Up to 12 different assays