cobas - Roche Diagnostics
cobas - Roche Diagnostics
cobas - Roche Diagnostics
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PCR Forum- November 2012<br />
Future Platform Solutions<br />
Impacts on molecular diagnostic labs<br />
December 4, 2012 page 1 ©2012 <strong>Roche</strong><br />
The <strong>cobas</strong> ® 6800/8800 Systems and associated assay products are currently in development, and not commercially available.<br />
Performance characteristics are subject to final local regulatory approval.
<strong>Roche</strong> Molecular <strong>Diagnostics</strong><br />
A rich history of innovation in PCR & molecular automation<br />
1983<br />
Discovery<br />
of PCR<br />
1988<br />
First<br />
commercial<br />
thermocycler<br />
1995<br />
COBAS ®<br />
AMPLICOR<br />
analyzer<br />
1998<br />
LightCycler ®<br />
Instrument<br />
2002<br />
COBAS ®<br />
TaqMan ® 48<br />
analyzer<br />
December 4, 2012 page 2 ©2012 <strong>Roche</strong><br />
2004<br />
2006<br />
<strong>cobas</strong> s<br />
201 system<br />
COBAS ® AmpliPrep /<br />
COBAS ® TaqMan ® System<br />
The <strong>cobas</strong> ® 6800/8800 Systems and associated assay products are currently in development, and not commercially available.<br />
Performance characteristics are subject to final local regulatory approval.<br />
2009<br />
<strong>cobas</strong> ®<br />
4800 system
Change Drives Innovation<br />
Main factors<br />
Over the next decade the industry will continue to experience sweeping changes<br />
driven by factors such as:<br />
• Ongoing lab & menu consolidation<br />
• Greater regulatory scrutiny<br />
• Increasing environmental concerns<br />
• Rising costs of skilled labor<br />
• Rising health and safety concerns<br />
In the earliest stages of design, the project team collected input from 45 high- and<br />
medium-throughput labs (a total of 86 people) in EMEA, North America, Japan and<br />
Korea.<br />
December 4, 2012 page 3 ©2012 <strong>Roche</strong><br />
The <strong>cobas</strong> ® 6800/8800 Systems and associated assay products are currently in development, and not commercially available.<br />
Performance characteristics are subject to final local regulatory approval.
Introducing the <strong>cobas</strong> ® 6800/8800 Systems<br />
Up to<br />
300<br />
tests/<br />
8hrs<br />
December 4, 2012 page 4 ©2012 <strong>Roche</strong><br />
Up to<br />
1000<br />
tests/<br />
8hrs<br />
<strong>cobas</strong> ® 6800 System <strong>cobas</strong> ® 8800 System<br />
The <strong>cobas</strong> ® 6800/8800 Systems and associated assay products are currently in development, and not commercially available.<br />
Performance characteristics are subject to final local regulatory approval.
<strong>cobas</strong> ® 6800 System<br />
A closer look<br />
Sample Supply<br />
module<br />
Transfer<br />
module<br />
Processing<br />
module<br />
December 4, 2012 page 5 ©2012 <strong>Roche</strong><br />
Analytical<br />
module<br />
Inventory<br />
manager<br />
The <strong>cobas</strong> ® 6800/8800 Systems and associated assay products are currently in development, and not commercially available.<br />
Performance characteristics are subject to final local regulatory approval.
<strong>cobas</strong> ® 8800 System<br />
A closer look<br />
Sample Supply<br />
module<br />
Transfer<br />
module<br />
Processing<br />
modules<br />
December 4, 2012 page 6 ©2012 <strong>Roche</strong><br />
Analytical<br />
modules<br />
The <strong>cobas</strong> ® 6800/8800 Systems and associated assay products are currently in development, and not commercially available.<br />
Performance characteristics are subject to final local regulatory approval.<br />
Inventory<br />
manager
The Sample Journey<br />
Sample Sample<br />
transfer transfer<br />
Sample Sample<br />
preparation preparation<br />
Amplification Amplification Result Result Result delivery Result delivery<br />
3 hrs<br />
& detection & detectioncalculation<br />
Calculation to LIS to LIS<br />
<strong>cobas</strong> ® 6800 System <strong>cobas</strong> ® 8800 System<br />
December 4, 2012 page 8 ©2012 <strong>Roche</strong><br />
The <strong>cobas</strong> ® 6800/8800 Systems and associated assay products are currently in development, and not commercially available.<br />
Performance characteristics are subject to final local regulatory approval.
Menu Consolidation<br />
Blood Screening and IVD assays on one platform<br />
WNV<br />
CMV<br />
HIV<br />
MPX<br />
(HIV/HCV/HBV)<br />
HEV<br />
DPX<br />
(B19V Quant/HAV Qual)<br />
HBV<br />
HCV<br />
Launch Menu Expansion<br />
December 4, 2012 page 9 ©2012 <strong>Roche</strong><br />
Blood Screening<br />
Dengue/Chikungunya<br />
CT/NG<br />
The <strong>cobas</strong> The ® <strong>cobas</strong> 6800/8800 ® 6800/8800 Systems Systems and associated and associated assay products assay are products currently are in currently development, in development, and not commercially and not commercially available. available.<br />
Performance characteristics are subject Performance to final local characteristics regulatory approval.<br />
are subject to final local regulatory approval.<br />
HPV<br />
HIVqual<br />
MTB/MAI<br />
IVD
Scalable Throughput<br />
Meeting your testing needs now and into the future<br />
Up to 5 systems can<br />
be managed from<br />
one server<br />
Work Area<br />
Manager<br />
December 4, 2012 page 10 ©2012 <strong>Roche</strong><br />
HL7 Compliant<br />
The <strong>cobas</strong> ® 6800/8800 Systems and associated assay products are currently in development, and not commercially available.<br />
Performance characteristics are subject to final local regulatory approval.<br />
LIS
<strong>cobas</strong> ® 6800/8800 Early Feasibility Trial<br />
Assay focus - MPX<br />
� Scope: preliminary evaluation of the MPX assay (HIV, HBV<br />
and HCV screening assay)<br />
� Site: Zurich Blood Transfusion Service SRC, Schlieren<br />
� Timeframe: January – February 2012<br />
� Objectives: Assay Robustness and Specificity<br />
� Specimens: Co-formulated positive panels<br />
� Configuration: C-trial-Proto 1.2<br />
MPX negative samples: 2000 from US<br />
December 4, 2012 page 11 ©2012 <strong>Roche</strong><br />
The <strong>cobas</strong> The ® <strong>cobas</strong> 6800/8800 ® 6800/8800 Systems Systems and associated and associated assay products assay are products currently are in currently development, in development, and not commercially and not commercially available. available.<br />
Performance characteristics are subject Performance to final local characteristics regulatory approval.<br />
are subject to final local regulatory approval.
<strong>cobas</strong> ® 6800/8800 Early Feasibility Trial<br />
Assay focus- HEV<br />
� Scope: Preliminary evaluation of the HEV assay<br />
� Site: Zurich Blood Transfusion Service SRC, Schlieren<br />
� Timeframe: May 2012, September/October 2012<br />
� Objectives: Assay Robustness and Specificity<br />
� Specimens: HEV positive panels<br />
� Configuration: C-trial-Proto 1.2 / 1.3<br />
HEV samples: 2000 from US, about 1500 from<br />
Switzerland<br />
December 4, 2012 page 12 ©2012 <strong>Roche</strong><br />
The <strong>cobas</strong> The ® <strong>cobas</strong> 6800/8800 ® 6800/8800 Systems Systems and associated and associated assay products assay are products currently are in currently development, in development, and not commercially and not commercially available. available.<br />
Performance characteristics are subject Performance to final local characteristics regulatory approval.<br />
are subject to final local regulatory approval.
<strong>cobas</strong> ® 6800/8800 Early Feasibility Trial<br />
Some Experiences from the laboratory<br />
� Functions: Well, with some characteristics of a prototype<br />
� Design: Functional concept, open view on mechanical parts<br />
� Usability: Very good<br />
� Software: Preliminary user interface<br />
December 4, 2012 page 13 ©2012 <strong>Roche</strong><br />
The <strong>cobas</strong> ® 6800/8800 Systems and associated assay products are currently in development, and not commercially available.<br />
Performance characteristics are subject to final local regulatory approval.
<strong>cobas</strong> ® 6800/8800 Systems<br />
Development timeline<br />
2008 2009 2010 2011 2012 2013 2014 2015<br />
Initial feasibility-critical concepts<br />
Prototype subset<br />
Universal concepts; bread board<br />
Early Feasibility Trials<br />
Pilot<br />
Early Feasibility Trials<br />
Prototype<br />
December 4, 2012 page 14 ©2012 <strong>Roche</strong><br />
Scope: get external feedback as early as possible in<br />
the assay development process.<br />
Configuration: Prototype with Sample Source and<br />
more SW Functionality then a Pilot system<br />
US Clinical Trials<br />
CE Registration Trials<br />
Series<br />
Early Feasibility Trials<br />
The <strong>cobas</strong> ® 6800/8800 Systems and associated assay products are currently in development, and not commercially available.<br />
Performance characteristics are subject to final local regulatory approval.
� Beat Frey<br />
� Karin Hardegger<br />
� Annegret Mechtold<br />
� Beatrix Gutknecht<br />
� Breanne Dufresne<br />
� Britta Seiverth<br />
� Mirjam Goerdes<br />
� Diana Thamke<br />
� Walter Bechel<br />
� Andrea Dummermuth<br />
� Christian Löwenstein<br />
December 4, 2012 page 15 ©2012 <strong>Roche</strong><br />
15<br />
The <strong>cobas</strong> ® 6800/8800 Systems and associated assay products are currently in development, and not commercially available.<br />
Performance characteristics are subject to final local regulatory approval.
Thank you for your attention.<br />
COBAS, TAQMAN, AMPLIPREP, COBAS S and LIFE NEEDS ANSWERS are trademarks of <strong>Roche</strong>.<br />
All third party product names and trademarks are the property of their respective owners.<br />
© 2012. <strong>Roche</strong> Molecular Systems, Inc. All rights reserved.<br />
<strong>Roche</strong> Molecular <strong>Diagnostics</strong><br />
4300 Hacienda Drive<br />
Pleasanton, CA 94588<br />
This presentation is our intellectual property. Without our written consent, it shall neither be<br />
copied in any manner, nor used for manufacturing, nor communicated to third parties.<br />
December 4, 2012 page 16 ©2012 <strong>Roche</strong><br />
The <strong>cobas</strong> ® 6800/8800 Systems and associated assay products are currently in development, and not commercially available.<br />
Performance characteristics are subject to final local regulatory approval.
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