NeuMoDx™ Molecular, a sample-to-result molecular diagnostic company focused on providing high throughput testing solutions to hospital and commercial reference laboratories, has been issued by the U.S. Food and Drug Administration (FDA) an Emergency Use Authorization (EUA) for the NeuMoDx™ SARS-CoV-2 Assay implemented on the NeuMoDx™ Molecular Systems.

The NeuMoDx™ SARS-CoV-2 Assay is a rapid, automated in vitro real-time RT-PCR diagnostic test for the direct detection of SARS-CoV-2 Coronavirus RNA from nasopharyngeal, oropharyngeal and nasal swab specimens in transport medium from individuals with signs and symptoms of infection of COVID-19. This multiplexed assay detects highly conserved regions of two SARS-Cov-2 genes, the Nsp2 geneand N gene, and uses different fluorophores for reporting each target.

#We’re All In This Together

NEUMODX SARS-COV-2 ASSAY

 


Fact Sheet for Healthcare Providers
DOWNLOAD PDF

Fact Sheet for Patients
DOWNLOAD PDF

 


FDA Notification
DOWNLOAD PDF

FDA Notification, EUA Amendment 04232020
DOWNLOAD PDF

 
 
 
 

Need Assistance? Talk to Us!

If you have questions, comments or need more information from our team, please fill out the form below and we will get back to you. Follow us on our social media to see our latest updates and job opportunities.


     

     

    Contact Details

    Please provide the following information for the person who experienced the issue:

    General Information

    DeathSerious adverse eventAdverse event (not serious)Product Problem (defects/malfunctions)Out of service/safety issueProduct use errorLabeling issue

     

     

    Initial use of assayRe-use of of instrumentRe-serviced/refurbishedProblem noted prior useDuplicate issueOther (please specify)

    TreatmentEvaluation

    False negative resultIncorrect qualification of the infection/Unclear resultsFalse positive resultDelayed reporting of resultsOther, please specify

    If available, email to: techsupport@neumodx.com (Include compliant in the subject line)

    Product Details

    Assay, Reagents and Consumables

    Instruments

    Action Taken


    IMPORTANT ANNOUNCEMENT

    We are excited to announce that QIAGEN has acquired all shares of NeuMoDx Molecular, Inc. The addition of NeuMoDx’s medium- and high-throughput molecular systems further expands QIAGEN’s portfolio of molecular diagnostics instruments, bolstering our leadership in automated molecular testing. We are proud to welcome NeuMoDx to our family of PCR solutions that make improvements in life possible.

    To learn more, click here.