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r COBAS TaqMan 48 Sales Brochure

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r COBAS TaqMan 48 Product Presentation

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

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

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r COBAS TaqMan with open thermalcycler

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r COBAS TaqMan Analyzers Common Features and Benefits Feature 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

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r COBAS TaqMan 48 Thermal Cyclers TC lid TC cover

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

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r COBAS TaqMan 48 K-carrier Transporter

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r COBAS TaqMan 48 Motorized K-tube Capper

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

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r High Pure System Viral Nucleic Acid Kit Overview

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

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r 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

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

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r High Pure System / COBAS TaqMan HBV Linearity/Dynamic Range Study HPS/CTM HBV linear range = 30 - 1.1E8 IU/ml

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r 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%

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r Roche HBV MONITOR Tests Comparison

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r Technical Comparisons 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) COBAS AMPLICOR HBV MONITOR (1000-4E7 copies/ml) sensitivity, samples detected below A HBM & CA HBM LOD in upper end of linear range, in number of samples requiring dilution or repeat testing

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

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r HighPure System/COBAS TaqMan HCV Test Limit of Detection SerumPlasma (EDTA)

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

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

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r High Pure System/COBAS TaqMan HCV Test Specificity

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r Technical Comparisons 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 AMPLICOR HCV MONITOR (600-850,000 IU/mL/mL)

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r Comparison CA HCM v. HPS/CTM HCV

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

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r Comparison HPS/CTM HCV vs. Bayer VERSANT bDNA

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

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r 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

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r HighPure/COBAS TaqMan 48 HIV-1 Test: Specificity

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r 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

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

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r Roche HIV-1 MONITOR Tests Comparison

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r TaqMan Assay Principle: 5Nuclease

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r 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)

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r 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 l EDTA Plasma or Serum Time to Result: ~ 5 hours

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

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r TaqMan Reagents: Performance for HIV-1

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

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r 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

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r 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