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NeuMoDx Gets FDA Emergency Use Authorization for Coronavirus Test

NEW YORK – NeuMoDx received Emergency Use Authorization from the US Food and Drug Administration on Monday for a COVID-19 assay on its fully automated, mid- and high-throughput diagnostics systems, according to a document posted on the agency's website.

Called the NeuMoDx SARS-CoV-2 Test Strip, the assay was authorized for the NeuMoDx 288 Molecular and NeuMoDx 96 molecular systems. It detects SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swab samples from patients suspected of having COVID-19, the disease caused by SARS-CoV-2 infection. The mulitplexed test detects the Nsp2 gene and the N gene of the virus, and the time to first results on the instrument is approximately 80 minutes 

The NeuMoDx systems are continuous, random-access analyzers that incorporate a proprietary dried reagent format, magnetic particle affinity capture, and real-time PCR, in a multi-sample microfluidic cartridge-based system. 

In 2018, NeuMoDx entered a partnership and milestone-based merger agreement with Qiagen, a firm that Thermo Fisher Scientific now plans to acquire. Qiagen also received EUA on Monday for its QIAstat-Dx Respiratory SARS-CoV-2 Panel.