NeuMoDx Molecular05.07.20
NeuMoDx Molecular, a sample-to-result molecular diagnostic company focused on providing high throughput testing solutions to hospital and commercial reference laboratories, announced plans to enhance its U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the NeuMoDx SARS-CoV-2 Assay implemented on the NeuMoDx Molecular Systems.
NeuMoDx received FDA Emergency Use Authorization for its SARS-CoV-2 Assay on March 31, and CE Marking for the test on May 4.
The current NeuMoDxSARS-CoV-2 Assay is a rapid, automated in-vitro real-time RT-PCR diagnostic test for the detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. NeuMoDx is now expanding its current workflow to include the ability to test clinician-collected saliva specimens and self-collected saliva specimens (collected in a healthcare setting) in the NeuMoDx Saliva Collection Device. The NeuMoDx SARS-CoV-2 Assay is available to CLIA-certified hospitals and clinical reference laboratories with experience performing moderate or high complexity tests.
The high throughput, fully automated NeuMoDx 288 and 96 Molecular Systems can provide results from the test 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 are provided in a 'ready to use' format for immediate processing without any need for refrigeration,” said Sundu Brahmasandra, Ph.D., 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 the World Health Organization and the Centers for Disease Control and Prevention, in order to immediately improve throughput and increase the volume of testing.
“As focus during this pandemic expands to include efforts for employees to return to work, it will be critical to provide additional specimen types to improve the efficiency and ease of sample collection,” said Jeff Williams, chairman and CEO of NeuMoDx. “We believe these additional specimen types will improve COVID-19 testing workflow as states reopen their economies.”
NeuMoDx received FDA Emergency Use Authorization for its SARS-CoV-2 Assay on March 31, and CE Marking for the test on May 4.
The current NeuMoDxSARS-CoV-2 Assay is a rapid, automated in-vitro real-time RT-PCR diagnostic test for the detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. NeuMoDx is now expanding its current workflow to include the ability to test clinician-collected saliva specimens and self-collected saliva specimens (collected in a healthcare setting) in the NeuMoDx Saliva Collection Device. The NeuMoDx SARS-CoV-2 Assay is available to CLIA-certified hospitals and clinical reference laboratories with experience performing moderate or high complexity tests.
The high throughput, fully automated NeuMoDx 288 and 96 Molecular Systems can provide results from the test 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 are provided in a 'ready to use' format for immediate processing without any need for refrigeration,” said Sundu Brahmasandra, Ph.D., 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 the World Health Organization and the Centers for Disease Control and Prevention, in order to immediately improve throughput and increase the volume of testing.
“As focus during this pandemic expands to include efforts for employees to return to work, it will be critical to provide additional specimen types to improve the efficiency and ease of sample collection,” said Jeff Williams, chairman and CEO of NeuMoDx. “We believe these additional specimen types will improve COVID-19 testing workflow as states reopen their economies.”