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GenMark
  • Panels
    • ePlex Panels
      • Respiratory
      • Blood Culture
    • XT-8 Panels
  • Systems
    • ePlex System
      • Software Solutions
      • Patient Safety
    • XT-8 System
  • Company
    • The GenMark Story
      • Management Team
      • Board of Directors
    • Careers
      • Opportunities
    • Investors
    • Newsroom
  • Education
    • Disease State
      • Sepsis
      • Respiratory Infections
      • Genetic Conditions
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      • GI Infections
    • Technology
    • Resources
  • Support
    • Contact Us
    • FAQs
    • Safety Data Sheets (SDS)
    • Your Long-Term Partner

 

XT-8® Panels

GenMark Diagnostics is committed to meeting customer needs with a broad menu of multiplex molecular products. The products presented in this section are available only in the U.S. at this time.

 

Respiratory Viral Panel
SARS-CoV-2 Test
Cystic Fibrosis Genotyping
Thrombophilia Risk Test
Warfarin Sensitivity Test
HCV Direct Test
2C19 Genotyping Test

Respiratory Viral Panel

GenMark’s Respiratory Viral Panel (RVP) provides sensitive and specific respiratory virus detection with an optimized workflow to maximize laboratory efficiency.

 

Comprehensive Testing

  • Detects 14 of the most common respiratory viruses associated with respiratory illness

 

Clear, Accurate Results

  • Single-page reports with easy-to-interpret results
  • The most sensitive RVP test based on independent studies including 99.2% agreement with qPCR1,2

 

Simple Workflow

  • Scalable workflow to meet peak demand
  • Batch based testing supports high throughput laboratories

 

Respiratory Viral Panel Targets

Adenovirus B/E

Influenza A 2009 H1N1

Adenovirus C

Influenza B

Human Metapneumovirus

Parainfluenza Virus 1

Human Rhinovirus

Parainfluenza Virus 2

Influenza A

Parainfluenza Virus 3

Influenza A H1

Respiratory Syncytial Virus A

Influenza A H3

Respiratory Syncytial Virus B

 

For in vitro diagnostic use

 

1. Pierce, V.M., Hodinka, R.L. (2012). Comparison of the GenMark Diagnostics eSensor Respiratory Viral Panel to Real-Time PCR for Detection of Respiratory Viruses in Children. Journal of Clinical Microbiology, 50(11), 3458-3465.
2. Popowitch, E.B. et al. An Analytical Comparison of Four Commercial Respiratory Virus Panels. Poster presented at 28th Annual Clinical Virology Symposium and Annual Meeting of the Pan American Society for Clinical Virology (PASCV); 2012 April 22-25; Daytona Beach, Florida.
3. Based on actual workflow studies conducted by GenMark scientists at customer sites. Times used are averages across multiple sites for calculations.

SARS-CoV-2 Test

The eSensor SARS-CoV-2 test is a qualitative multiplex assay designed to detect SARS-CoV-2 nucleic acid in nasopharyngeal swabs collected in viral transport media.

 

This test utilizes the design principles of GenMark’s eSensor Respiratory Viral Panel (RVP), which has been recognized as one of the most sensitive RVP assays available.1 The eSensor SARS-CoV-2 Test consists of PCR amplification and detection reagents test cartridges which are run on the XT-8 System. The eSensor SARS-CoV-2 Test can provide results for 96 samples in 5 hours; laboratories set up for high-throughput, 96-well plate processing of clinical specimens can process 384 specimens per day.

 

Simple Workflow

 

 

This product is distributed according to section IV.C.2 (FDA Notifications) of FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

 

 


1. 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.

Cystic Fibrosis Genotyping Test

GenMark’s Cystic Fibrosis Genotyping Test uses innovative eSensor® technology to provide patients with accurate genetic carrier screening results.

 

Comprehensive Testing

  • Panel includes the 23 recommended mutations from the American College of Obstetricians and Gynecologists and the American College of Medical Genetics guidelines

 

Clear, Accurate Results

  • Single page report with easy to interpret results
  • 100% accuracy and reproducibility in clinical studies

 

Simple Workflow

  • Results in approximately 4 hours including extraction1
  • 40 minutes of hands-on time1

 

 

For in vitro diagnostic use

 

 

1. Based on actual workflow studies conducted by GenMark scientists at customer sites. Times used are averages across multiple sites for calculations.

Thrombophilia Risk Test

GenMark’s Thrombophilia Risk Test uses innovative eSensor® technology to provide a complete picture of inherited risk, aiding in individualized treatment decision-making.

 

Comprehensive Testing

Detection of all four thrombophilia-related genetic markers:

  • Factor II (Prothrombin, FII)
  • Factor V (Leiden, FV)
  • MTHFR 677 and MTHFR 1298

 

Flexible Reporting

5 customized report options:

  • Full Panel
  • FV
  • FII
  • FV/FII
  • MTHFR 677 and 1298

 

Clear, Accurate Results

  • Single-page reports with easy-to-interpret results
  • 100% accuracy and reproducibility in clinical trial

 

Simple Workflow

  • Results in approximately 4 hours including extraction1
  • 40 minutes of hands-on time1

 

 

For in vitro diagnostic use

 

 

1. Based on actual workflow studies conducted by GenMark scientists at customer sites. Times used are averages across multiple sites for calculations.

Warfarin Sensitivity Test

GenMark’s Warfarin Sensitivity Test uses innovative eSensor® technology to help identify patients at risk for warfarin-related adverse events.

 

Comprehensive Testing

  • Detection and genotyping of the *2 and *3 alleles of the cytochrome P450 (CYP450) gene and VKORC1 (-1639G>A)

Clear, Accurate Results

  • Single-page report with easy-to-interpret results and anticipated level of patient sensitivity
  • 100% accuracy and reproducibility in clinical studies

Simple Workflow

  • Results in approximately 4 hours including extraction1
  • 40 minutes of hands-on time1

 

 

For in vitro diagnostic use

 

 

 

1. Based on actual workflow studies conducted by GenMark scientists at customer sites. Times used are averages across multiple sites for calculations.

HCV Direct Test

The HCVg Direct Test is designed to type and subtype Hepatitis C virus (HCV) 1a, 1b, 2, 2a/c, 2b, 3, 4, 5, and 6.

 

Simple Workflow

 

 

For Research Use Only. Not for use in diagnostic procedures.

 

2C19 Genotyping Test

The 2C19 Genotyping Test is designed for the multiplex detection and genotyping of the *2, *3, *4, *5, *6, *7, *8, *9, *10, *13 and *17 alleles of the cytochrome P450 (CYP450) 2C19 gene.

 

 

Simple Workflow

  • Results in approximately 4 hours including extraction1
  • 40 minutes of hands-on time1

 

For Research Use Only. Not for use in diagnostic procedures.

 

 

 

1. Based on actual workflow studies conducted by GenMark scientists at customer sites. Times used are averages across multiple sites for calculations.

GenMark Diagnostics, Inc.
5964 La Place Court
Carlsbad, CA 92008

 

© Copyright 2021 GenMark Diagnostics, Inc.
All rights reserved.

 

info@genmarkdx.com
P: +1 760-448-4300
F: +1 760-448-4301

 

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