QIAGEN – Prevention Update on QIAensemble · 2013-04-26 · QIAGEN Analyst and Investor Day,...

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


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


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


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!


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 )


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!


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)

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

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


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 PipettorClass 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 HC2Unprecedented throughput and utility

Broad menu of assays based on amplification

Today

Tomorrow



PerformanceDrivers

.


.


Leverage the strengths of leadership in molecular screening


Objectives


Screening Platform

Building for the Future MDx Screening (Prevention) Workstation

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


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 diseaseCancer Prevention/ScreeningOther 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?

ThroughputAnalytical sensitivity


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


.

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+


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 in a single run (random batch access)

Value Creation: Best Use of People

Requirement for lower skilled operators promotes greater degrees of cross-training amongst laboratory personnel

Senior level med techs freed up for new revenue generation

Reduced repetitive motion injuries

Maximum walk-away time e.g. continuous loading

Best Economics

Value Creation: Best Economicssignificantly reduces waste removal costs due to no HazMat waste and minimal plastic waste removal

The QIAsymphony® sp/QIAensemble™ 3000+ Benchtop Workcell offers the best platform consolidation opportunity for today’s hospital marketplace.



PerformanceDrivers

.


.


Leverage the strengths of position in molecular screening


Objectives


Screening Platform

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

MDx Screening (Prevention) WorkstationTrue Automation Means Real Value


QIAensemble Status/Timeline

Ensemble System Component Commercialization Date(s)

QIAensemble System -

Evolution

digene HPV PS 16, 18, 45 genotyping reagents Launched: Sept. 2009

QIAsymphony SP -

AXpH CSC*: Q2 2010; FDA: Q2 2011

QIAensemble Decapper Q3 2010

QIAensemble SP –

hc2 CSC: Q2 2011; FDA TBD

QIAensemble System -

Revolution

QIAensemble 3000+ System with CT/GC menu Prototype Q1 2010

QIAensemble 400 with screening/genotyping CE Mark: Q3 2010

QIAensemble SP/2000 with screening and genotyping

FDA approval: Q3 2012

QIAensemble 3000+ System with HPV and CT/GC menu

Instrument migration study submission to follow immediately after FDA approval of QIAensemble System

QIAGENcares

careHPV SFDA approval: Q2 2011 –

Q2 2012; CE Mark Q2 2010

*CSC –

clinical sample concentrator status, 510(k) exempt, GMP compliant for use in LDT and IVD applications


QIAensemble Clinical Trial Highlights

Trial Highlights

Completed (2) Pre-IDE Meetings with FDAPreservCyt® and Digene Co-collection Media (DCM) Samples

Approximately 100 sample collection sites; 3 sample testing sitesFirst collection and sample testing sites under contract and IRB

Approximately 40,000 patientsInitial phase of the trial 9-12 monthsIntended Use Claims:

ASCUS TriageCo-Testing women over 30 years old

Final stages of selecting CROFDA approval: Q3 2012


.

Thank you !

QIAGEN – Prevention Update on QIAensemble · 2013-04-26 · QIAGEN Analyst and Investor Day,...

Documents

Transcript of QIAGEN – Prevention Update on QIAensemble · 2013-04-26 · QIAGEN Analyst and Investor Day,...