© Cepheid – Proprietary and Confidential

GeneXpert® Technology

2013

© Cepheid – Proprietary and Confidential 2

A Better Way to Platform Design

GX-I

GX-XVI

GeneXpert® Infinity-4880

GeneXpert® Module

GX-II GX-IV

© Cepheid – Proprietary and Confidential 3

Defining Molecular Diagnostics

The GeneXpert®

Family of Systems

GeneXpert®

Module

GeneXpert®

Cartridge SmartCycler®

Tube SmartCycler®

System

ICORE®

Module

Any Test

Any Time

Any Sample

Any Place

© Cepheid – Proprietary and Confidential 4

Delivering A Better Way

EASY

To Use

FAST

Answers

ACCURATE

Results

Delivering a Better Way to Realize the Benefits of Molecular Diagnostics

© Cepheid – Proprietary and Confidential 5

Platforms

I-CORE module

GeneXpert®

module

SmartCycler® Instrument

GeneXpert® Instrument

BDS

© Cepheid – Proprietary and Confidential 6

Cepheid Technology

SmartCycler®

GeneXpert®

© Cepheid – Proprietary and Confidential 7

GeneXpert® System Components

GeneXpert System includes:

• Modules Thermal and optical system

• Cartridge Self-Contained

Disposable

• Computer System Software

Barcode scanner

• Optional Accessories

Printer

UPS

© Cepheid – Proprietary and Confidential 8

GeneXpert® Technology

This technology includes:

• Instrument platform

• Test cartridges

• Dedicated protocols and Controls

© Cepheid – Proprietary and Confidential 9

GeneXpert® Technology

• Exploits proven SmartCycler® technology (Incorporated same “solid-state” thermal

cycler/fluorometer module)

•Employs an integrated and closed fluid transfer system

• Uses multiplex, rapid real-time PCR technique (6-colors)

• Based on microfluidics-based reconstitution, and simplification of automated

filling

Utilizes families of cartridges to address wide range of applications

and specimen types

© Cepheid – Proprietary and Confidential 10

No wet interface between instrument and cartridge to eliminate carry-over

Integrated ultrasonic horn for rapid lysis of spores

Total internal control of reagent system –

• No separate external positive or negative controls required

Smart fluidics

• Encoded software driven motors for valve movement and integral hydraulic drives

• Advanced micro fluidics technologies to enable complex sample prep processing

protocols (many milliliters down to 10 micro liters)

Automated data reduction and results interpretation

GeneXpert® Design Approach

© Cepheid – Proprietary and Confidential 11

Cepheid Technology

MasterMix

Other real-time instrument

Amplification Detection Analysis Positive

Negative

Patient

Sample

Washing

DNA

extraction DNA

purification

GeneXpert®

© Cepheid – Proprietary and Confidential 12

Automated Xpert® MTB/RIF Protocol

in less than 2h

© Cepheid – Proprietary and Confidential 13

The I-Core Module

Building Block of the Smart Cycler® and GeneXpert®

© Cepheid – Proprietary and Confidential 15

Reaction

tube

Plunger Motor

Motherboard

I-CORE

Valve Drive Motor

Cartridge inserter

A micro lab: GeneXpert® module + cartridge

+

Valve

Body

Processing

Chambers

Ultrasonic Horn

© Cepheid – Proprietary and Confidential 16

Inside Chamber

ICORE tube

insertion

Valve drive (wedge) Ultrasonic horn

Plunger drive shaft

© Cepheid – Proprietary and Confidential 17

GeneXpert® Cartridge

This is a self-contained system

Amplification tube Amplification tube

Valve Body Valve Body

Chambers contain

reagents, primers and

probes , buffers and

extracted sample

Chambers contain

reagents, primers and

probes , buffers and

extracted sample

By turning, it directs the

fluids into the different

chambers and the PCR

tube.

By turning, it directs the

fluids into the different

chambers and the PCR

tube.

Allows you to perform

a rapid thermal

cycling and optical

excitation/detection

Allows you to perform

a rapid thermal

cycling and optical

excitation/detection Processing Chambers Processing Chambers

© Cepheid – Proprietary and Confidential 18

PCR Tube Cartridge Body

Syringe Barrel

Cap/Ultrasonic Interface

Rotary Valve/Filter and

Ultrasonic Lysis region

Cartridge Foot

. .

Cartridge Exploded View

Syringe drive

Valve body Ports

© Cepheid – Proprietary and Confidential 19

GeneXpert® Cartridge

• GX cartridge has 11 chambers

• Lower numbered chambers are used for sample

processing

• Higher numbered chamber are used for reagents

• Two types of cartridges

– Cartridge A

– Cartridge C

• Both cartridge A and C has identical body

construction. Only difference is the bottom part

Pre-filter or

Funnel

Cartridge A

only

© Cepheid – Proprietary and Confidential 20

Difference between cartridge A and cartridge C

Cartridge A Cartridge C

Xpert®

MTB/RIF

© Cepheid – Proprietary and Confidential 21

Cartridge Side View

Target-specific reagent bead:

primers; probe; controls; Mg2+;

excipients

Enzyme reagent bead:

Taq polymerase; dNTPs; … Buffer, Mg

2+; salts; excipients…

Sample Preparation bead:

Controls, excipients

+ Liquid Reagents

Retaining balls

© Cepheid – Proprietary and Confidential 22

Video

Please load the training documents and the training video on the above FTP

link:

Please copy and paste this link in EXPLORER, not INTERNET

EXPLORER

ftp link * ftp://hbdc:Crasa7Uc@ftp.caplaser.net