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.

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Fact Sheet for Healthcare Providers

Fact Sheet for Patients


FDA Notification

FDA Notification, EUA Amendment 04232020


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    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)


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

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    Assay, Reagents and Consumables


    Action Taken


    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.