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Product in Development Sample-to-Answer Multiplex Molecular Diagnostics

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GNMK-IMC-1039-A

Gastrointestinal Pathogen Panel (GI)n Bacterial, viral, and parasitic targets

associated with gastrointestinal infections from a stool sample

HCV Genotyping Panel (HCVg)n Typing and subtyping of HCV 1a, 1b, 2a/c,

2b, 3, 4, 5, and 6 from plasma or serum

Central Nervous System Panel (CNS)n Bacterial, viral, and fungal targets associated

with central nervous system infections from a cerebrospinal fluid sample

Fungal Pathogen Panel (FP)n Fungal targets associated with bloodstream

infections from positive blood culture

Product in Development

Sample-to-Answer Multiplex Molecular Diagnostics

Electrowetting Technology

n Proprietary electronic fluid

movement technology

n Enables rapid thermal cycling

for fast turnaround time

Sample-to-Answer Solution

n Single use, self-contained cartridge

n Fully integrates nucleic acid extraction,

amplification, and detection

n No user-added reagents

CAPTURE PROBE

SIGNAL PROBE PATIENT DNA

FERROCENE LABEL

GOLD ELECTRODE

eSensor® Detection

n Proprietary electrochemical

detection technology

n Multiplexing with high sensitivity

and specificity

n Eliminates the need for routine

instrument maintenance

and calibration

GenMark is committed to providing patient-focused solutions to aid in the diagnosis of disease and the selection and dosing of therapies. Utilizing eSensor® detection technology, the ePlex™ sample-to-answer system

is being designed to support a broad range of multiplex molecular diagnostic panels.

CU

RR

EN

T N

AN

OA

MP

S

VOLTAGE

40

35

30

25

20

15

10

5

0-0.2 0.0 0.2 0.4 0.6

Ferrocene SignalBackground Current

nA

/m

m2

POTENTIAL (V)

180

170

160

150

110

130

100-0.2 0.0 0.2 0.4 0.6

Wild Type (WT)Mutant (MUT)Heterozygous (HET)

120110

Excellent Sensitivity and Specificity Demonstrated in Independent Studies

Scalable Configuration & Throughput

1 Pierce, V.M., Hodinka, R.L. 2012. Comparison of the GenMark Diagnostic eSensor Respiratory Viral Panel to Real-Time PCR for Detection of Respiratory Viruses in Children. Journal of Clinical Microbiology. doi:10.1128/JCM.01384-12. 2 Popowitch, E.B, O’Neill, S.S., Miller, M.B. Comparison of Four Multiplex Assays for the Detection of Respiratory Viruses: Biofire FilmArray RP, GenMark eSensor RVP, Luminex xTAG RVPv1 and Luminex xTAG RVP FAST. J. Clin. Microbiol.

13 March 2013, doi: 10.1128/JCM.03368-12.

Random and Continuous Access

Run any assay, any time

Flexible Design 1 to 4 towers to address testing

capacity requirements

192

144

96

48

1 2 3 4

Towers

Sample Throughput (6 samples per tower, based on 8-hour shift)

GenMark is committed to providing patient-focused solutions to aid in the diagnosis of disease and the selection and dosing of therapies. Utilizing eSensor® detection technology, the ePlex™ sample-to-answer system

is being designed to support a broad range of multiplex molecular diagnostic panels.

Author Comparator Method eSensor® XT-8 Performance

Popowitch1 Molecular Multiplex Tests 99.6% Overall Sensitivity*

Pierce2 PCR 99.2% Agreement

LIS

Bi-directional LIS Interface

Download test orders and upload results

Fast Turnaround

Sample to result in 60-90 minutes

*GenMark’s eSensor XT-8 RVP is designed to detect only Rhinovirus. The data presented is based on the removal of three Enterovirus specimens.

GNMK-IMC-1039-A

Respiratory Pathogen Panel (RP) n >20 viral and bacterial targets

associated with respiratory infections from a nasopharyngeal swab

Blood Culture Identification Gram-Positive Panel (BCID-GP)n >20 bacterial and resistance targets

associated with bloodstream infections from positive blood culture

Blood Culture Identification Gram-Negative Panel (BCID-GN)n >25 bacterial and resistance targets

associated with bloodstream infections from positive blood culture

Gastrointestinal Pathogen Panel (GI)n Bacterial, viral, and parasitic targets

associated with gastrointestinal infections from a stool sample

HCV Genotyping Panel (HCVg)n Typing and subtyping of HCV 1a, 1b, 2a/c,

2b, 3, 4, 5, and 6 from plasma or serum

Central Nervous System Panel (CNS)n Bacterial, viral, and fungal targets associated

with central nervous system infections from a cerebrospinal fluid sample

Fungal Pathogen Panel (FP)n Fungal targets associated with bloodstream

infections from positive blood culture

Comprehensive Multiplex Panels*

Solutions to aid diagnosis and accelerate treatment decisions

GenMark Diagnostics, Inc.5964 La Place CourtCarlsbad, CA 92008USA

[email protected] genmarkdx.com

*Product in Development. Not available for sale in the US. Panel targets and specifications subject to change.Copyright © 2014, GenMark Diagnostics. GenMark®, GenMark Dx®, eSensor®, ePlex™, and XT-8™ are trademarks of GenMark Diagnostics, Inc.

GenMark Diagnostics Europe GmbHGeneral-Guisan-Strasse 66303 ZugSwitzerland [email protected]

To learn more about the ePlex™ system, contact us at [email protected].