The US FDA has issued an emergency use authorization (EUA) for the NeumoDx SARS-CoV-2 Assay, which can deliver results in about 80 minutes, according to manufacturer NeumoDx Molecular.
The test 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.
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.
“Our proprietary NeuDry technology enables efficient automation of the NeumoDx SARS-CoV-2 Assay, as all reagents and consumables do not require refrigeration and are provided in a ‘ready-to-use’ format for immediate processing,” said Sundu Brahmasandra, PhD, president and COO.
Additionally, the NeumoDx Systems allow laboratories to efficiently validate their own SARS-Cov-2 laboratory developed tests, including those provided by WHO and the CDC, in order to immediately improve throughput and increase the volume of testing.