NeuMoDx COVID-19 test receives U.S. FDA authorization for emergency use

April 1, 2020
The multiplexed assay detects highly conserved regions of two SARS-Cov-2 (COVID-19) genes, and uses different fluorophores for reporting each target.

NeuMoDx Molecular (Ann Arbor, MI), a sample-to-result molecular diagnostic company focused on providing high-throughput testing solutions to hospital and commercial reference laboratories, has received a U.S. Food and Drug Administration (FDA) 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 reverse-transcription polymerase chain reaction (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 gene and N gene, and uses different fluorophores for reporting each target. The assay is available to CLIA-certified hospitals and reference laboratories with experience performing high-complexity tests. 

The high-throughput, fully automated NeuMoDx 288 and 96 Molecular Systems can provide the first test results in as little as 80 minutes from primary collection or daughter tubes. The company's NeuDry technology enables efficient automation of the assay, as all reagents and consumables do not require refrigeration and are provided in a “ready to use” format for immediate processing, says Sundu Brahmasandra, Ph.D., president and chief operating officer of NeuMoDx.  

With the NeuMoDx SARS-CoV-2 Assay, the company's systems integrate the entire process of testing for SARS-CoV-2, from specimen lysis through detection or ‘sample to result,” and provide operators with the ability to load up to 288 patient samples in a continuous, random-access workflow, resulting in on-demand, high-throughput testing. The systems also allow laboratories to efficiently validate their own SARS-Cov-2 Laboratory Developed Tests, including those provided by WHO and the CDC, to immediately improve throughput and increase the volume of testing. 

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Source: NeuMoDx Molecular press release – March 31, 2020

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BioOptics World Editors

We edited the content of this article, which was contributed by outside sources, to fit our style and substance requirements. (Editor’s Note: BioOptics World has folded as a brand and is now part of Laser Focus World, effective in 2022.)

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