3
BEYOND EXPECTATIONS REFERENCES: 1. Based on independently-validated workflow study. Details furnished upon request. 2. GenMark Annual Customer Satisfaction survey, by Survey Monkey 2015. Details furnished upon request. *For In Vitro Diagnostic Use. ^CE-IVD. Not available for sale in the US. †Product in Development. Not available for sale in the US. Panel targets and specifications subject to change. © 2017 GenMark Diagnostics, Inc. GenMark, GenMark Dx, ePlex, The True Sample-to-Answer Solution, and Designed for the Patient, Optimized for the Lab are trademarks or registered trademarks of GenMark Diagnostics, Inc. GNMK-IMC-2052-B GenMark Diagnostics, Inc. 5964 La Place Court Carlsbad, CA 92008 USA [email protected] GenMark Diagnostics Europe GmbH Chollerstrasse 4 6300 Zug Switzerland [email protected] Respiratory Pathogen (RP) Panel* The most common clinically-relevant viral and bacterial targets associated with upper respiratory infections Blood Culture Identification Panels ^ (BCID-GP, BCID-GN, and BCID-FP) Designed to provide the most comprehensive coverage of sepsis-causing organisms to improve clinical outcomes and antibiotic stewardship Gastrointestinal Pathogen (GI) Panel Bacterial, viral, and parasitic pathogens associated with gastrointestinal infections Comprehensive ePlex ® Menu For more information on ePlex ® please visit www.genmarkdx.com GMD-16609 ePlex Solutions Brochure Updates r4.indd 1-2 10/31/17 4:10 PM

Respiratory Pathogen (RP) Panel*€¦ · GenMark is committed to remaining an industry leader in customer satisfaction. Year after year, respondents rank GenMark as delivering best-in-class

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Page 1: Respiratory Pathogen (RP) Panel*€¦ · GenMark is committed to remaining an industry leader in customer satisfaction. Year after year, respondents rank GenMark as delivering best-in-class

BEYONDEXPECTATIONS

REFERENCES: 1. Based on independently-validated workflow study. Details furnished upon request. 2. GenMark Annual Customer Satisfaction survey, by Survey Monkey 2015. Details furnished upon request.

*For In Vitro Diagnostic Use. ^CE-IVD. Not available for sale in the US. †Product in Development. Not available for sale in the US. Panel targets and specifications subject to change.

© 2017 GenMark Diagnostics, Inc. GenMark, GenMark Dx, ePlex, The True Sample-to-Answer Solution, and Designed for the Patient, Optimized for the Lab are trademarks or registered trademarks of GenMark Diagnostics, Inc. GNMK-IMC-2052-B

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

[email protected]

GenMark Diagnostics Europe GmbHChollerstrasse 46300 ZugSwitzerland [email protected]

Respiratory Pathogen (RP) Panel* The most common clinically-relevant viral and bacterial targets

associated with upper respiratory infections

Blood Culture Identification Panels^

(BCID-GP, BCID-GN, and BCID-FP)Designed to provide the most comprehensive coverage of

sepsis-causing organisms to improve clinical outcomes and

antibiotic stewardship

Gastrointestinal Pathogen (GI) Panel†

Bacterial, viral, and parasitic pathogens associated with

gastrointestinal infections

Comprehensive ePlex® Menu

For more information on ePlex® please visit www.genmarkdx.com

GMD-16609 ePlex Solutions Brochure Updates r4.indd 1-2 10/31/17 4:10 PM

Page 2: Respiratory Pathogen (RP) Panel*€¦ · GenMark is committed to remaining an industry leader in customer satisfaction. Year after year, respondents rank GenMark as delivering best-in-class

ePlex®: The True Sample-to-Answer SolutionTM

ePlex is the only sample-to-answer

system that streamlines the diagnostic

workflow from physician order entry

to the final test report with accurate,

actionable results. ePlex offers

unique solutions to address the most

significant challenges facing clinical

laboratories, while supporting hospital

systems to deliver patient-centered,

value-based care.

True Sample-to-Answer Workflow

ePlex delivers lean, true sample-to-answer workflow to support 24/7 testing with consistent

order-to-report service levels.

• Shortest hands-on time among multiplex sample-to-answer systems1

• Bi-directional LIS, automating and accelerating order entry and results reporting

• Random, continuous access with a modular, scalable design to provide capacity during

peak season demand

Patient Safety

ePlex reduces the potential for patient identification and reporting errors, so labs and physicians

can report results with confidence.

• Patented positive patient ID reduces the potential for patient sample mix-up

• True bi-directional LIS can help eliminate transcription errors

Patient-Centered Care

ePlex provides rapid, comprehensive test results for critical patients to help institutions lower

overall cost of care by reducing length of stay and inappropriate use of certain therapies, while

also improving key quality metrics including infection control and antimicrobial stewardship.

Compliance & Data Management

Maximize lab efficiency by reducing the administrative overhead associated with monitoring

lab performance, tracking quality control testing, and managing data required for regulatory

compliance.

• Automated QC tracking and onboard QC test records help ensure the lab runs controls

when required

• Integrated data analytics and on-demand epidemiology reports

Your Long-Term Partner

GenMark is committed to remaining an industry leader in customer satisfaction. Year after year,

respondents rank GenMark as delivering best-in-class service and support.2

• Secure, remote access capability for on-demand ePlex troubleshooting and diagnostics

• On-site training, preventative maintenance, repairs, and LIS integration assistance

Only ePlex provides bi-directional LIS capability with sample traceability throughout the testing process to streamline and integrate workflow. The system consistently delivers fast, accurate, and clinically actionable results to enhance patient care.

SUMMARYAdenovirus, Parainfluenza Virus 2 and Respiratory Syncytial Virus A Detected.

Operator Signature Approver SignatureDate Date

Viral Targets ResultAdenovirus DetectedCoronavirus 229E Not DetectedCoronavirus HKU1 Not DetectedCoronavirus NL63 Not DetectedCoronavirus OC43 Not DetectedHuman Metapneumovirus Not DetectedHuman Rhinovirus/Enterovirus Not DetectedInfluenza A Not Detected Influenza A H1 Not Detected Influenza A 2009 H1N1 Not Detected Influenza A H3 Not DetectedInfluenza B Not Detected

Viral Targets ResultParainfluenza Virus 1 Not DetectedParainfluenza Virus 2 DetectedParainfluenza Virus 3 Not DetectedParainfluenza Virus 4 Not DetectedRespiratory Syncytial Virus A DetectedRespiratory Syncytial Virus B Not Detected

Bacterial TargetsBordetella pertussis Not DetectedChlamydophila pneumoniae Not DetectedMycoplasma pneumoniae Not Detected

Internal Control PASS

RESULTS

COMMENTS

FLAGS

1 / 110/25/2016 3:16 PM For In Vitro Diagnostic Use.

Regional Medical Center | 5964 LaPlace Ct, Carlsbad, CA

RP Detection ReportAccession ID:

Protocol:

Instrument Serial Number:Operator:Software Version:

Date/Time Completed:Bay Location:

Cartridge Expiration Date:Cartridge Lot Number:Cartridge ID:

555666777888

RP 1.3.15.21.0.6.1Internal1541100045

10/25/2016 3:15 PMA112345614062516204810/18/2018

Patient ID: Unknown

Test Ordering / Sample Collection

Central Receiving & Sort

Transport to Lab Accession

SampleReport Results

Process Sample

Physician Test Order

Physician Test Results

Test ResultsTest Order

GMD-16609 ePlex Solutions Brochure Updates r4.indd 3-4 10/31/17 4:10 PM

Page 3: Respiratory Pathogen (RP) Panel*€¦ · GenMark is committed to remaining an industry leader in customer satisfaction. Year after year, respondents rank GenMark as delivering best-in-class

Signature Manifest

Document Number: GNMK-IMC-2052 Revision: B

Title: ePlex Solutions

All dates and times are in Pacific Standard Time.

EU Address and disclaimer update

Approval

Name/Signature Title Date Meaning/Reason

Scott O'Brien (OBRIENS) VP, Global Prod. Marketing 01 Nov 2017, 03:28:54 PM Approved

Eric Stier (STIERE) SVP & General Counsel 01 Nov 2017, 03:37:06 PM Approved

Al Maderazo (MADERAZOA) VP RA & QA 02 Nov 2017, 02:19:41 PM Approved

Tina Aiello (AIELLOT) Sr. Administrative Assistant 02 Nov 2017, 03:56:50 PM Approved

Tricia Patterson (PATTERSONT)

Sr. Product Marketing Manager

06 Nov 2017, 10:21:47 AM Approved

Release

Name/Signature Title Date Meaning/Reason

Dzung M Kim (KIMD)

Tho Tran (TRANT)

Elizabeth Tuite (TUITEE)

Y Tran2 (TRANY2) Document Control Specialist 06 Nov 2017, 02:30:40 PM Approved

Page 1 of 1Signature Manifest

11/6/2017file:///C:/Adlib%20Express/Work/20171106T150023.708/%7B60997108-7BD7-44...