QIAGEN Development Programs Innovation in Sample and Assay Technologies Dr. Joachim Schorr

QIAGEN Development Programs
Innovation in Sample and Assay Technologies
Dr. Joachim Schorr
Senior Vice President Global R&D
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
Forward Looking Statements
Safe Harbor Statement: Certain of the statements contained in this presentation 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 and markets and operating results are forward-looking, such statements are based on
current expectations 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), variability of operating
results, the commercial development of the DNA sequencing, genomics and synthetic nucleic
acid-related markets, as well as the nucleic acid-based molecular diagnostics, applied testing
markets and genetic vaccination and gene therapy markets, competition, rapid or unexpected
changes in technologies, fluctuations in demand for QIAGEN's products (including fluctuations
for certain events including funding, budgets, and others), 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 its products from competitors, and the
integration of acquisitions of technologies and businesses. For further information, refer to the
discussion in reports that QIAGEN has filed with or furnished to the U.S. Securities and
Exchange Commission (SEC).
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
Agenda
Global R&D Organization
R&D Project Portfolio
QIAGEN Innovations
Technology Roadmap: Planning the Future
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
1
Global R&D
Competence Center in USA , Europe and Asia
North America
Asia
Assay & Systems
Development
Women's Health
(HPV, CT,NG)
Assay
Development
siRNA
Europe
Application Labs
Application Development
Application
Development
Assay Development
Applied Testing
Automated Systems
GEX; Proteomics; Corp. R&D
Systems Integration, Microfluidics
450 Scientists in Research & Development
Enabling Technologies for Sample Preparation in Life Science, Applied Testing, MDx
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
R&D Competence Center
Focus on Applications & Customer Segments
Applications
Application
DNA
Molecular
Diagnostics
Gene Function
Amplification &
modification
Protein
Customer Segments
DNA Handling, Purification
Genotyping, Storage, ...
Diagnostic Sample Technology,
Assay Technology (HC&PCR), Content
Life Science Research
Gene Silencing
Gene Expression
Pharma
PCR and other Amplification Technologies
Proteomics
Sample and Assay Technologies
Applied Testing
Automated
Systems
Basic Research
Sample and Assay Technology, automated
New Technology Development
Molecular Diagnostics
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
2
Portfolio Teams
Defining Product Applications within Customer Segment
Customer Segments
Products & Projects
„ artus
RPA
(Regulated
Products)
„
„
„
B. pertussis LC PCR Kit RUO
Enterovirus LC RT-PCR Kit RUO
WNV LC RT-PCR Kit RUO
Molecular Diagnostics
„ QIAplex Assays
„
„
„
„
Mvplex RUO
ResPlex III
HAI
Y.chromosome
„ MagAttract Virus+Blood IVD for EZ1
„ Cador
„
BVDV PCR Screening Kit RUO
„
BVDV PCR Subtyping Kit RUO
„
Taylorella, Rabies PCR Kits RUO
Applied Testing
hc (hybrid capture) 2.0 Add-ons
Women’s
Health
Molecular Diagnostics
Next Generation Hybrid Capture
Screening Assay and Platform
NexGen Hybrid Capture Genotyping Assay
(„Probe Set“)
NexGen Plus Isothermal Amplification Assays
Fast HPV („dcHPV = developing countries“)
Diagnostic PCR Genotyping Assays
(Luminex-detection)
Custom PCR Genotyping Assays for Pharma
(Luminex-detection)
QIAGEN Analyst and Investor Day, February 14, 2008
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Pharma
Sample & Assay Technologies
Portfolio Teams
Defining Product Applications within Customer Segment
Products & Projects
Application
DNA
Customer Segments
„ REPLI-g FFPE DNA Kit
„ REPLI-g Fragmented DNA
„ SBTexcellerator HLA
„ QIAcube Applications
Life Science Research
Gene Silencing
„ Genome siRNA Sets
„ miRNA assays + reagents
Gene Function
Gene Expression
„ AllPrep DNA/RNA 96
„ RNeasy 96 Plus
„ QuantiTect Multiplex Virus
„ Quantifast
„ Fastlane 1-step qRT-PCR
„ WTA (Whole Transcriptome Amplification)
„ EpiTect controls
Applied Testing
Protein
„
„
„
„
„
Expression constructs on Gene Globe
Qxp crude lysate
NTA Univ. System
EasyXtal custom screens
Recombinant Membrane Protein Purification
„ QIAcube
Automated
Systems
„ EZ1 CE IVD
Pharma
„ QIAsymphony
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
3
R&D Budget Allocation
Women’s
Health
~30%
~15%
Automated
Systems
~15%
RPA
~5%
Gene Function
~3%
Gene
Expression
~3%
Protein
Application
DNA
~3%
~2%
Basic Research
Reg./ IP &
Other
QIAGEN Analyst and Investor Day, February 14, 2008
~20%
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Sample & Assay Technologies
Agenda
Global R&D Organization
R&D Project Portfolio
QIAGEN Innovations
Technology Roadmap: Planning the Future
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
4
R&D Development Process:
Gate review & focus
PT
Phase 0
PRC
PRC
PRC
Phase 2
Phase 1
PRC/GRM
PRC
Phase 3
Launch
Phase 4
168 Phase 0-2 Projects
58 Phase 3-5 Projects
Total Innovation Index
Project Portfolio
5
7,0
6,0
4
P roject A ttractiven ess
In n o v a tio n G ra d e
5,0
4,0
3,0
3
2
2,0
1
1,0
0
0,0
0,0
1,0
2,0
3,0
4,0
5,0
6,0
0
7,0
1
2
3
4
5
Project Performance
Market Attractivity
Sample & Assay Technologies
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QIAGEN Analyst and Investor Day, February 14, 2008
58 Phase 3-5 Projects
Selection by Project Attractiveness & Performance
Project Score
Project Portfolio
Project E
5
P ro je c t A ttra c tiv e n e s s
4
Project A
1
Project A
6,7
2
Project B
6,7
3
Project C
6,6
4
Project D
6,4
5
Project E
6,3
6
Project F
6,3
7
Project G
6,2
8
Project H
6,1
9
Project I
5,9
10
Project J
5,8
11
Projekt K
5,8
12
Project L
5,8
13
Project M
5,8
14
Project N
5,8
15
Project O
5,7
3
2
Project G
Project M
1
0
0
1
2
3
4
5
Project Performance
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
5
Agenda
Global R&D Organization
R&D Project Portfolio
QIAGEN Innovations
Technology Roadmap: Planning the Future
Sample & Assay Technologies
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QIAGEN Analyst and Investor Day, February 14, 2008
Define the Field of Innovation
Identical Workflows In All Areas Of Life Sciences
Collection
Stabilization &
Storage
Life Science Research
Disruption
Enrichment
Pharma
Purification
Amplification /
Modification
Applied Testing
Content
Detection
Molecular Diagnostics
QIAGEN Analyst and Investor Day, February 14, 2008
Bio-informatics
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Sample & Assay Technologies
6
Portfolio Team Output: 170 New Products
New Products Launched in 2005, 2006 and 2007
2005
REPLI-gKit
HotStar HiFidelity ; HotStarTaq Plus
REPLI-g Service
CompactPrep Plasmid
BIOROBOT Universal
EZ1 RNA Universal Tissue ; RNA Cell Mini
RNeasy Plus Mini Kit
QuantiTect Primer Assay
TurboCapture 8 / 96 / 384
AllPrep DNA/RNA Mini Kit
QuantiTect Multiplex RT-PCR
HiPerFect Transfection Reagent
Qproteome div.
PAXgene Blood RNA Kit CE, FDA & MDx
dNTP Mix
Appl. Pack
QuantiTect Rev.Transcription Kit (50)
FastLane Cell cDNA
HP Guaranteed siRNA ;
HP Flexible siRNA Design ;
HP GenomeWide siRNA ;
Customized siRNA Gene Sets
Customized siRNA Gene Sets ;
Genome Sets div.
Ni-NTA Fast Start ; BioSprint 15
EasyXpress div
LiquiChip Total Detection Kits div.
BioSprint 15 / 96 DNA Plant
2006
2007
HotStarTaq Plus Master Mix ; QIAGEN Fast Cycling ;
QIAGEN LongRange
QuickLyse Miniprep ; QIAGEN PlasmidAmp
MaXtract Low Density ; QIAGEN RNase Inhibitor ; IPTG ;
Nuclease-Free Water
EpiTect Bisulfite Kit, GelPilot
EZ1 DNA Investigator Kit
EZ1 Virus Mini Kit v2.0, TissueRuptor + TissueRuptor Probes
RNeasy Protect Saliva ; RNeasy FFPE ; RNeasy Protect Cell Mini
RNAprotect Cell Reagent, AllPrep RNA Protein Kit
FlexiPlate siRNA (tube + plate)
AllStars Neg. siRNA
miRNeasy Mini Kit ; miRNeasy 96 Kit
EasyXtal ; NeXtal, MassSpecSamplePrep
artus (new kits)
PAX Bone Marrow
Autopure Consumables, Puregene,
Autopure Instrument,
Generation
dNTP Set
REPLI-g UltraFast ; REPLI-g Screeing ; REPLI-g Mitochondrial
EZ1 DNA Investigator Card ; EZ1 VRS Card V2.0
App. Package, M48
QuantiTect Rev.Transcription Kit (200)
QuantiTect
Qproteome Plasma Membrane ; Qproteome Mitochondria ;
Qproteome FFPE Tissue
EasyXpress Insect Kit II ; EasyXpress Linear Template Kit Plus
EasyXpress pIX3.0 Vector Qproteome GlycoArray Kit
REPLI-g Fragmented DNA Kit
QuantiTect Multiplex Virus
REPLI-g (human-ID)
QIAcube
EZ1 CE IVD
QIAsymphonie
Quantifast
Fastlane 1-step qRT-PCR
WTA
Allprotect Reagent
Rat 1.0
miRNA assays + reagents
Genaco
MagAttract Virus+Blood IVD for EZ1 IVD
SBTexcellerator HLA
PAX xNA RNA Blood
QIAGEN Analyst and Investor Day, February 14, 2008
Sample & Assay Technologies
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QIAGEN Innovations
Examples of 2007 & 2008 Product Launches
Stabilization &
Storage
Allprotect Tissue Reagent
QIAcube & QIAsymphonySP
Purification
Amplification /
Modification
Content
Reverse Transcriptase HotStart
.
BVDV PCR Screening Kit
QIAxcel
Detection
QIAsymphony: Integrated Platform Technology
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
7
Allprotect Tissue Reagent
Stabilization &
Storage
Features
„ Proprietary stabilization technology
„ Simultaneous preservation of DNA, RNA and
native proteins in one tissue sample
„ Immediate stabilization of harvested tissues
„ Shipment / storage
„ 1 day at 37°C
„ up to 7days at 25°C
„ at least 12 months at 2-8°C
„ archiving at -20°C/-80°C
„ Compatible with “all” QIAGEN kits for target
purification
„ Wide range of downstream assays
„ Non-toxic
QIAGEN Analyst and Investor Day, February 14, 2008
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tion
a
v
o
Inn
Aw
2
ard
7
00
Sample & Assay Technologies
Bovine Viral Diarrhea Virus (BVDV)
Content
Mucosal Disease MD
„ BVD Virus
„ Pest virus in cattle (also sheep and goats)
„ Closely related to
„ Border Disease Virus in sheep
„ Classical Swine Fever Virus
„ Infertility, abortion, congenital defects in calves
„ Persistent infected (PI) calves
constant source of reinfection
„ Mucosal Disease (MD), severe deadly infection
„ Not infectious to man
„ BVDV costs US$20 – US$160 per year and animal
„ US$ 97M & EU 85M cattle
„ Eradication programs in several countries
high awareness
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
8
Complete Solution From Sample To Result
Content
Sample & Assay Technologies For BVD Testing
Sample Technologies
Assay Technologies
Automated sample prep
„ BioRobot Universal System
cador BVDV RT-PCR Kit
cador BVDV Type 1/2 RT-PCR Kit
Manual sample prep
„ QIAamp Viral RNA Mini Kit
„ RNeasy Mini Kit
Additional veterinary assays
„ artus M. paratuberculosis LC PCR Kit
„ artus Influenza/H5 LC RT-PCR Kit
„ Further assays under development
TissueLyser
QIAGEN Analyst and Investor Day, February 14, 2008
Sample & Assay Technologies
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T1 Product Launches 2008
Product
ADNA
Product
„ CompactPrep mega/giga
RNAi
„ QIASymphony system
„ EZ1 Advanced
AIS
„ QIAxcel System/cartridges
„
„
„
„
„
FlexiPlate Gene Family updates
Human WG/DG siRNA Set v 4.0
AllStars hs cell death control
miScript additions
New DNA transfection reagent
„ Next generation Lipofection &
Nanofection
„ HiPerFect for miRNA
„ Online transfection protocols
„ QIAcube: additional protocols
Gene
Function
„ TissueLyser II
RPA
Protein
„ FPLC Column extension NTA, StrepTactin 5ml cartridges
„
„
„
„
„
„
QIAcard FTA
QIAsafe
VET BVDV PCR Screening Kit
VET BVDV PCR Subtyping Kit
VET Taylorella PCR Kit RUO
QIAamp DSP Virus Kit Modif. CD&US
T1 = Term 1 (January – April)
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
9
Selected Regulatory Approval Projects
Europe
Year
Project
2008
2009
2010
2011
artus HIV RG
artus HCV RG
EZ1 upgrade virus
Candor BVDV TM RT Kit
QIAplex ResPlex II
NextGen
HPV Genotyping
Approval/Launch
Submission
Running / planned project
Sample & Assay Technologies
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QIAGEN Analyst and Investor Day, February 14, 2008
Selected Regulatory Approval Projects
USA
Year
Project
2008
2009
2010
2011
artus CMV LC
artus EBV LC
artus CMV + EBV Taqman
HLA I
HLA II
QIAplex ResPlex II
NextGen HPV Screening
HPV Genotyping
DML 3000
HAI
Running / planned project
510K Submission
QIAGEN Analyst and Investor Day, February 14, 2008
PMA Submission
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Approval/Launch (typically 12 months after submission)
Sample & Assay Technologies
10
Selected Regulatory Approval Projects
Asia
Year
Project
2008
2009
2010
2011
Blood Screening Project
PG Biotech HBV Kit
PG Biotech HCV Kit
PG Biotech HIV Kit
Fast HPV
Running / planned project
QIAGEN Analyst and Investor Day, February 14, 2008
Approval/Launch (typically 12 months after submission)
Submission
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Sample & Assay Technologies
Agenda
Global R&D Organization
R&D Project Portfolio
QIAGEN Innovations
Technology Roadmap: Planning the Future
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
11
Technology Roadmap: Sample and Assay Technologies
Structure base on identical Workflows in all segments
Stabilization &
Storage
Life Science Research
Automated Systems
Disruption
Purification
Amplification /
Modification
Assay Technologies
Pharma
Enrichment
Integrated Microsystems
Sample Technologies
Collection
Applied Testing
Molecular Diagnostics
Content
Detection
Bio-informatics
Sample & Assay Technologies
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QIAGEN Analyst and Investor Day, February 14, 2008
Technology Roadmap Results
From 3000 Technologies to 100 Projects
1
2
3
Technology Life Cycle
Norm Strategies
Technology Overview
Emerging
Technology
Program software
„ C++
„ ….
Key Technology
Ko
nze
ptio
nell
Technology
Plan
Technology
Implementation
Activities
QIAGEN’s Relative Technology Position
Year
Quarter
2005
Q1
Q2
Development
Growth
Maturity
high
In
ve
st
72
14
strong
51
Pilot Projects
“little resources”
1
ve
st
Alarm signal for
persent
Alarm signal for
survival
Maturity
Decrease
Monitoring
low
medium
Development
Growth
I
14. Xxx
2008
Q4
Q1
Q2
Q3
Q4
Launch on track
·
Next Step: Alternative to Venus
·
·
Big uncertainty for launch date
·
Next Step: Targets
·
Resource allocation critical!
·
·
Estimated launch date: Q2/06
17. Xxx
Millipore collaboration unclear
18. Xxx
Forensic, Vet, Biodefense
19. Xxx
V
Technological Competitive Position
Q3
··
·
·
11. Xxx
15. Xxx
Disinvest
Life Cycle Stage of Technology
high
Q2
·
9. Xxx
16. Xxx
Obsolete
Technologies
54
low
Q1
10. Xxx
13. Xxx
IV
Q4
Kits on track, controls delayed
71
72
2007
Q3
·
·
12. Xxx
54
Alarm signal for future
Q2
·
6. Xxx
7. Xxx
tenable
Q1
·
3. Xxx
4. Xxx
8. Xxx
Optimization
“short ROI”
52
4
73
Technological Life Cycle (Technological Development Status)
Q4
·
2. Xxx
5. Xxx
II
21
22
D
es
in
Invest
“long ROI”
III
Industry average
med
8
Decrease
Alarm signal for
waste of
ressources
1
62
25
55
Opportunities for
present
competitive
advantage
Opportunities for future advantage
Core
Technologies
2006
Q3
1. Xxx
high
New
Technologies
(for QIAGEN)
Usability
HMI
„ …..
5
Base
Technology
medium
Software
LIMS Standards
„ CMV
„ XML
Pacing Technology
Evaluation of Relevance
Consumables
„ Process cartridges and
reagents, tubes, tips
„ ……
Technology Attractiveness
Network / Data
Integration
Sensors
„ Standard sensors
† 1-D Barcode
† 2-D Barcode
† ……
Liquid Handling
„ Fluid systems
„ Air displacement
systems
„ ....
low
Drive Technologies
Drive control
„ DC, step motor
„…
T e ch n o lo g y P e r fo r m a n ce
Process Technologies
„ Magnetic bead
handling
„ …. Cont.
4
20. Xxx
·
·
· Major decision point
Delay >60 days
Dela y 30-60 days
On track
Resources
t
Overview on
>3000
Technologies
„
Approx. 1000
Technologies
analyzed
Approx.200
Technologies
identified as Relevant
For QIAGEN
Implementation and
Ranking of 100 new
projects
-
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
12
Exploring Translational Research:
Roadmap to new Diagnostic Content
Sample & Assay Technologies
QIAGEN Analyst and Investor Day, February 14, 2008
Key Elements for new Content Discovery:
Collaboration Goals
Validated
Samples
International network will provide excess to relevant diagnostics patient samples
Guarantee standardized sample management of patient samples
Sample
Management
Integrated Data
Analysis
„
Collection
„
Stabilization
„
Purification & Automation
Need for unique algorithm to perform integration of multiple data types
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
13
Van Andel Institute
Unique Institution
„ Independent Research Institution
Founded in 2000
„ 250 Scientists & Staff
„ Phase II 800
„ Scientific Advisory Board of
5 Nobel Laureates
„ Focused on Translational Research
from Bench Side to Bedside
„ Significant Endowment
„ International Expansion
„ Success through Collaboration
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
Traditional Work Process
Clinic
ResearchGrants
Data
Data Mgt
Publish
Data
Analysis
Public
Data
ClinicalPatients
Records
Clinical
Samples
Diagnostics
Treatments
TIME
Discovery
Application
Limited Integration –> In-Efficient Translation
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
14
Integrated Approach
Application
Clinic
Diagnostics
Treatments
Patients
Retrospective
Analysis
Clinical
Samples
Clinical
Records
Public Research Data
Analysis
Data
Molecular
Data Mgt
Data
Prospective
Application
Discovery
Discovery to Application Through Integration
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
Exploring Translational Research
Key Elements in Place
Through network collaborations (selection)
Excess to
Samples
„
Exprimage: 20.000 FFPE Cancer Samples
„
Van Andel Breast Cancer Study: 185 Patients full data set
„
PROCEED: Early diagnosis of prostate cancer : 33 cancer risk related gene
signatures
FFPE Samples represent the vast majority of all tumor tissue samples
Sample &
Analytes
„
Advantage is the fixation of morphology
„
Challenge has been the extraction of Analytes
„
QIAGEN Technology can extract DNA, RNA & Proteins from the same
FFPE sample
XenoBase BioIntegration Suite (van Andel Institute)
BioInformatics
„
Data Access & Management
„
Visualization Tools
„
Research & Analysis
„
Reporting
„
Prospective Diagnostics
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
15
Questions & Answers
QIAGEN Analyst and Investor Day, February 14, 2008
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Sample & Assay Technologies
16
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