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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