Sample & Assay Technologies QIAGEN 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
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QIAGEN – Prevention Update on QIAensemble · 2013-04-26 · QIAGEN Analyst and Investor Day, February 11, 2010 Sample & Assay Technologies QIAGEN – Prevention Update on QIAensemble.
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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
PerformanceDrivers
.
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’sNext-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
benchtopconfiguration
LIS
LBC Vials
Urine
Vials
LBC Vials
Urine Vials
AnalyticalSample Prep
Co-collected DCM™ - HPVUrethral 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 assaysCancer prevention (screening) assaysInfectious diseasesOther , 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 capacityplate stacker)
192 DCM™
capacityloading bay
2000 results / 8 hrs
2000 DCM™ / shift
QIAensemble™ 2000PreservCyt®& SurePath®*
vials
15 plates8 hrsX 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
Warning: QIAensemble System in
Use.
Repetitive M
otion Free Zone!
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 2Current
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-reactivitywith 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)