NeuMoDx Molecular, Ann Arbor, Mich, has secured the CE mark for its NeuMoDx SARS-CoV-2 assay, a rapid, automated in vitro real-time RT-PCR test for the direct detection of SARS-CoV-2 RNA.

The test is performed on nasal swab, nasopharyngeal, or oropharyngeal specimens in transport medium from individuals with signs and symptoms of covid-19 infection. The multiplexed assay detects highly conserved regions of two SARS-CoV-2 genes, the Nsp2 gene and N gene, and uses different fluorophores for targeting each gene.

Sundu Brahmasandra, PhD, NeuMoDx Molecular.

Sundu Brahmasandra, PhD, NeuMoDx Molecular.

Hospitals and reference laboratories can run the test on the high-throughput, fully automated NeuMoDx 288 or NeuMoDx 96 molecular systems, which can provide 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,” says Sundu Brahmasandra, PhD, president and chief operating officer at NeuMoDx.

For more information, visit NeuMoDx Molecular.