COBAS TaqMan 48 Sales Brochure

COBAS TaqMan 48 Product Presentation

Evolution of Roche Diagnostics Platforms (RMD) Degree of Automation 1992 1995 1996 2001 2003 MWP COBAS AMPLICOR COBAS AMPLIPREP Automated Sample Preparation AMPLIPREP& COBAS TaqMan 96/ TaqMan 48 AMPLILINK MONITOR COBAS TaqMan 48

COBAS TaqMan 48 First Real Time PCR Platform that Offers IVD & Utility Channel mode Programmable Benchtop analyzer 2 independent 24-well Thermal Cyclers (two tests simultaneously) AmpliLink 3.0.1 Software Windows XP operating Sytems Run sizes of 6-48 samples

COBAS TaqMan with open thermalcycler

COBAS TaqMan Analyzers Common Features and Benefits Kinetic PCR Integrated Quantification Standard requires no external standard curves Closed Tube Format Four color channels (upgrade to six planned) Sample vessel: k-tube or k-plate Benefit Broad dynamic range No separate detection Assay time reduction from 6h to 2-3 hours Increases Throughput Provides internal control Eliminates contamination risk Allows multiplexing Will allow additional formats (Hybridization Probes) Easy handling Automation through AmpliPrep

COBAS TaqMan 48 Thermal Cyclers TC lid TC cover

K-tube, K-carrier, K-carrier holder K-carrier with barcode

COBAS TaqMan 48 K-carrier Transporter

COBAS TaqMan 48 MotorizedK-tube Capper

Post Launch improvements K-Plate & K-caps in new K-carrier design (in development)

High Pure System Viral Nucleic Acid Kit Overview

COBAS TaqMan 48 Workflow with manual or automated sample prep Manual Sample Prep September 2003 Automated Sample Prep July 2004

High Pure System Viral Nucleic Acid Kit (redesigned - 12 samples format) 1 = Lysis Rack 2 = Filter Tube Rack 3 = Waste Container 4 = Elution Rack 5 = Cover Rack 6 = Grippers One kit = 48 preps 4 plates with 12 Columns per plate; Lysis, Filter, Elution Rack

High Pure System Viral Nucleic Acid Kit/COBAS TaqMan TM HBV Test Performance

High Pure System / COBAS TaqMan HBV Linearity/Dynamic Range Study y = 1.0124x - 0.2358 R 2 = 0.9989 Error Bars = 1 Standard Deviation -1.00 0.00 1.00 2.00 3.00 4.00 5.00 6.00 7.00 8.00 9.00 Nominal Concentration Log 10 (HBV DNA IU/ml) High Pure System Viral Nucleic Acid Kit / COBAS TaqMan HBV Test Result (HBV DNA IU/mL) HPS/CTM HBV linear range = 30 - 1.1E8 IU/ml

High Pure System / COBAS TaqMan HBV - Limit of Detection Study HPS/CTM HBV can detect HBV DNA in EDTA-plasma and serum at concentrations as low as 5.9 IU/ml with a positivity rate greater than 95%

Roche HBV MONITOR Tests Comparison

Technical Comparisons  sensitivity,  samples detected below A HBM & CA HBM LOD  in upper end of linear range,  in number of samples requiring dilution or repeat testing COBAS AMPLICOR HBV MONITOR (1000-4E7 copies/ml) COBAS AMPLICOR HBV MONITOR (300-200,000 copies/ml) High Pure System/COBAS TaqMan HBV (170-6.4E8 copies/ml, 95% at 35 copies/mL)

High Pure System Viral Nucleic Acid Kit/COBAS TaqMan TM HCV Test Performance

HighPure System/COBAS TaqMan HCV Test Limit of Detection Plasma (EDTA) Serum

HPS/CTM HCV linear range = 30 - 2E8 IU/ml High Pure System/COBAS TaqMan HCV Test Linearity/Dynamic Range Study - Serum HPS/CTM HCV linear range = 30 - 2E8 IU/ml

High Pure System/COBAS TaqMan HCV Test Linearity/Dynamic Range Study - Serum

High Pure System/COBAS TaqMan HCV Test Specificity

Technical Comparisons AMPLICOR™ HCV MONITOR (600-850,000 IU/mL/mL) COBAS AMPLICOR™ HCV MONITOR (600-500,000 IU/mL/mL) High Pure System/COBAS TaqMan™ Test HCV (30->2E8 IU/mL, LOD = 95% at 10 IU/mL)  sensitivity,  samples detected below CA HCM LOD  in upper end of linear range,  in number of samples requiring dilution or repeat testing

Comparison CA HCM v. HPS/CTM HCV

High Pure System/COBAS TaqMan HCV Test Correlation to Bayer Versant HCV bDNA 3.0

Comparison HPS/CTM HCV vs. Bayer VERSANT® bDNA

High Pure System Viral Nucleic Acid Kit/COBAS TaqMan TM HIV-1 Test Performance

HighPure/COBAS TaqMan 48 HIV-1 Test: Linear Range Data support: 37 cp/mL to 1.03E7 cp/mL Claim: 40 cp/mL - 1E7 cp/mL

HighPure/COBAS TaqMan 48 HIV-1 Test: Specificity

HighPure/COBAS TaqMan 48 HIV-1 Test: Interference of Clinical Specimens No Interference of Clinical Specimens Infected with HTLV-1, HTLV-2, HIV-2, HAV, HBV, HCV and EBV

HighPure/COBAS TaqMan 48 HIV-1 Test: Interference of HIV Antiviral Drugs

Roche HIV-1 MONITOR Tests Comparison

TaqMan™ Assay Principle: 5‘Nuclease

Additional Instrumentation required Water bath - 50 C Sigma Bench Top Centrifuge - 4600 g Centrifuge art 10732 Swing Out Rotor art.11118 Check Price at local Sigma Distributors (Export)

HPS/CTM HCV Test Performance Characteristics Sensitivity: 10 IU/ml Dynamic Range: 30 - 2E8 IU/ml Specificity: >99.99% Genotype inclusivity: 1-6 Sample Input: 500 µl EDTA Plasma or Serum Time to Result: ~ 5 hours

TaqMan Reagents: Performance for HBV (report in IU/ml)

TaqMan Reagents: Performance for HIV-1

Future Parameters COBAS TaqMan® 48 Analyzer CT CT/NG CMV HSV 1,2 FV Leiden Prothrombin (G20210A) Cytochrome P450 2C9

COBAS TaqMan COBAS TaqMan integrates amplification and detection in a homogenous fluorescent assay format for easy quantification of target copy numbers Real Time data collection allows monitoring of the PCR process in each individual cycle instead of end point measurement after completion of all cycles Closed tube format safeguards against potential product carry over contamination Kinetic measurement broadens the dynamic range of our virological assays to provide accurate viral load information TaqMan technology is a more sensitive and reproducible method for viral load monitoring and thereby enables better treatment decisions Roche Molecular Diagnostics continues to make PCR testing routine in the clinical laboratory with the benefits provided by the COBAS TaqMan Analyzer.

Advantages of the Taqman® Tests Single-tube amplification and real time detection: QS and Target Eliminates post-PCR manipulations Closed system: minimizes contamination Fewer reagents and disposables required Sensitive and probe-specific Broad dynamic range Walk-away system Small volume of tests/ day