The BeadXpressThe BeadXpressSystem: Maximizing

MultiplexingMultiplexing Capabilities for

Infectious DiseaseInfectious Disease Testing

Gianluca Roma Product Manager

© 2010 Illumina, Inc. All rights reserved.Illumina, illuminaDx, Solexa, Making Sense Out of Life, Oligator, Sentrix, GoldenGate, GoldenGate Indexing, DASL, BeadArray, Array of Arrays, Infinium, BeadXpress, VeraCode, IntelliHyb, iSelect, CSPro, GenomeStudio, Genetic Energy, and HiSeq are registered trademarks or trademarks of Illumina, Inc. All other brands and names contained herein are the property of their respective owners.

Illumina’s First FDA Cleared In-Vitro Diagnostic Device

► The BeadXpress System is an FDA 510(k) cleared In-Vitro Diagnostic DeviceDevice

► FDA Cleared BeadXpress System includes:– BeadXpress Reader– VeraScan SoftwareVeraScan Software

► The Intended Use Statement:– The BeadXpress® System is an In-Vitro Diagnostic

Device intended for the simultaneous detectionDevice intended for the simultaneous detection of multiple analytes in a DNA sample utilizing VeraCode holographic microbead technology. The BeadXpress System consists of the BeadXpress Reader and VeraScan software.BeadXpress Reader and VeraScan software.

BeadXpress Reader and

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BeadXpress Reader and VeraScan Software

VeraCode Holographic Microbead Technology

► Cylindrical glass microbeads

► 240 μm length x 28 μm diameter

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BeadXpress™ Reader: Specifications

SAMPLE DELIVERY FORMAT Standard 96 well plate & 8 well strip platesSAMPLE DELIVERY FORMAT Standard 96-well plate & 8-well strip plates

MULTIPLEXING PER SINGLE WELL 1 to 384MULTIPLEXING PER SINGLE WELL 1 to 384

DETECTION Optional 1 or 2 color detectionDETECTION Optional 1 or 2 color detection

THROUGHPUT 120 samples/hr at 10-plex 80 samples/hr at 96-plex

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Analyzer for Multiple Applications

GENOTYPING

100000

10000AnalyteFit

GENE REGULATION PROTEIN EXPRESSIONIL-6 (6152)

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VeraCode Bead Loading & Alignment

CAPILLARY FORCE ATTRACTS BEADS INTO GROOVES

GROOVE PLATECROSS-SECTION

BEADS FALLINTO GROOVE

PLATE

BEADS ALIGN TIGHTLY FOR OPTIMAL

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SCANNING EFFICIENCY

Code Detection

BEAD CCD LINE ARRAY

“READING”BEAM

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PixelPixelPixelPixelPixelPixelPixelPixelPixelPixelPixelPixelPixelPixelPixelPixelPixelPixel

VeraScan 2.0 – System Operation to Report

Authentication Test selection & setup

Scan

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Analysis & ReportOptional off-line analysis and review

Enabling Clinical Early Adopter

FDA cleared BeadXpress SystemRegulated device ensures quality and performance standardsRegulated device ensures quality and performance standards are meet for clinical laboratories

General Purpose Reagent BeadsEnables customers to develop their own assays using royalty-free beads

Path to FDA SubmissionsBeadXpress clearance and GMP reagents create a platform for follow-on diagnostic development

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follow on diagnostic development

Enabling Diagnostic Partners

Signed agreements with EraGen:Signed agreements with EraGen:

Expanded MenuEraGen can port content to BeadXpress

Improved WorkflowFaster chemistry on BeadXpress

EraGen potential transfer menu includes:p

CFTR, Factor II/V, MTHFR Respiratory Viral Panel CYP2C9 & VKORC1

Reduced labor costs Faster turnaround Enables further menu expansion CYP2C9 & VKORC1

BeadXpress 510(k) Clearance Removes a Significant Hurdle

pin infectious disease

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BeadXpress 510(k) Clearance Removes a Significant Hurdle for development of diagnostic tests by Partners

EraGen Workflow on BeadXpress

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Multiplex Assay Workflow ComparisonStep Description Time

Automation Friendly

EraGen Workflow AnalysisSample* to Answer

RXN 20 µL Master Mix 0:05

ILMN(EraGen) 2:35

Prep Transfers = 0Washes = 0Filtration = 0Labor (hrs) = 0.25

Setup Mix10 µL Sample

0:05

PCR Amplify and Label 1:30

Third Wave 5:30Prep Transfers = 1Washes = 1Filtration = 0Labor (hrs) = 3

Hyb Setup

50 µL Hybridization Buffer30 µL Reaction

0:05

Luminex (TmBio) 6:30

Prep Transfers = 1Washes = 1Filtration = 1Labor (hrs) = 2

Hybridization

Room Temperature @ 850 RPM

0:15

96 Clinical Specimens7:00

BeadXpress

Read Full Plate (96 Samples) 0:40

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96 Clinical Specimens Total Assay Time: 2:35

*Workflows start from extracted DNA

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Molecular Diagnostic Market Segments

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A Paradigm Shift in Microbiology

Culture-based - ID Molecular - ID

Advantages of Molecular - ID:– SpeedSpeed– Wide range of detectable organisms (viruses, fungi, bacteria,

etc.)Enhanced test Sensitivity & Specificity– Enhanced test Sensitivity & Specificity

– Resistance marker detection (e.g. MRSA)– Epidemiologic: genotyping of outbreak strains (e.g Flu A H1N1

2009)2009)

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Advantages of Multiplexed Molecular Panels

Increase Productivity A med tech may increase output without a need to work more or A med tech may increase output without a need to work more or longer days

D CDecrease Costs Reagent costs per analyte is lower for multiplex vs. singleplexus

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Challenges in Microbiology

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Comparison: PCR Testing

RT- PCR Singleplex VeraCode MultiplexRT- PCR Singleplex VeraCode Multiplex

=

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Summary

The 510 (K) FDA – Cleared BeadXpress System is an ideal platform for multiplexed infectious diseases testing.

Multiplexing enhances workflow efficiency and reduce labMultiplexing enhances workflow efficiency and reduce lab costs.

Multiplexing allows the testing of common and rare infectious organisms on a more routine basisorganisms on a more routine basis.

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Questions?Questions?

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