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NeuMoDx Plans Saliva Sample Extension for SARS-CoV-2 Test Emergency Use Authorization

– High throughput system with results in as little as 80 minutes –

May 8, 2020 (Ann Arbor, Michigan) 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.

The current NeuMoDx SARS-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 health care 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, 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. “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.”

About NeuMoDx™

NeuMoDx™ Molecular designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories. Our patented, ‘sample-to-result’ platform offers market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve. For more information visit  www.neumodx.com.

Coronavirus Assay Information

NeuMoDx™ Molecular, a sample-to-result molecular diagnostic company focused on providing testing solutions to hospital and commercial reference laboratories, has developed a SARS-CoV-2 Assay for use on the high throughput, fully automated NeuMoDx™ 288 and 96 Molecular Systems. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the NeuMoDx™ SARS-CoV-2 Assay implemented on the NeuMoDx™ Molecular Systems.

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