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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
