NeuMoDx Molecular, Ann Arbor, Mich, has announced plans to request an enhancement of its FDA emergency use authorization for the NeuMoDx SARS-CoV-2 assay, which is performed on the company’s molecular analyzers.
The NeuMoDx SARS-CoV-2 assay is an automated in vitro real-time RT-PCR diagnostic authorized for the detection of SARS-CoV-2 RNA from bronchoalveolar lavage specimens or nasal, nasopharyngeal, or oropharyngeal swabs in transport medium from individuals suspected of having covid-19. NeuMoDx is seeking to expand this workflow to include testing of saliva specimens collected in the NeuMoDx saliva collection device.
Using samples provided in primary collection or daughter tubes, the high-throughput, fully automated NeuMoDx 288 and NeuMoDx 96 molecular systems can provide test results in as little as 80 minutes.
“Our proprietary NeuDry technology enables efficient automation of the NeuMoDx SARS-CoV-2 assay, as all reagents and consumables are provided in a ‘ready to use’ format for immediate processing, without any need for refrigeration,” says Sundu Brahmasandra, PhD, president and chief operating officer of NeuMoDx.
For more information, visit NeuMoDx.