NeuMoDx announces CE marking for SARS-cov2 test

NeuMoDx™ Molecular, a sample-to-result molecular diagnostic company focused on providing high throughput testing solutions to hospital and commercial reference laboratories, announced it has secured the regulatory CE Mark approval for its 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 RT-PCR diagnostic test for the direct detection of SARS-CoV-2 Coronavirus RNA from nasopharyngeal, oropharyngeal, or 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 targeting each gene.

Hospitals and reference laboratories can run the test on the high throughput, fully automated NeuMoDx 288 and 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.” said Sundu Brahmasandra, PhD., President and Chief Operating Officer of NeuMoDx.

NeuMoDx offers fully automated solutions that integrate the entire molecular diagnostic process – 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. 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. “NeuMoDx is committed to employing its technology and resources to join the global effort to limit the continued spread of Coronavirus,” said Jeff Williams, Chairman and CEO of NeuMoDx. “We believe our easy-to-use, high throughput systems allow laboratory clinicians to rapidly increase the volume of SARS-CoV-2 testing conducted by their lab.Williams also noted that NeuMoDx has a strategic partnership with QIAGEN N.V. in which QIAGEN distributes the NeuMoDx™ 288 (high-throughput version) and NeuMoDx™ 96 (mid-throughput version) in Europe and other major markets worldwide outside of the United States.


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