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Preparing to Launch Coronavirus Test

March 12, 2020 (Ann Arbor, Michigan)  NeuMoDx™ Molecular, a sample-to-result molecular diagnostic company focused on providing testing solutions to hospital and commercial reference laboratories, announced today its plans for a SARS-CoV-2 Assay for use on its high throughput, fully automated NeuMoDx™ 288 and 96 Molecular Systems.  SARS-CoV-2 is the Coronavirus that has been determined to cause COVID-19 infections.

The NeuMoDx™ SARS-CoV-2 Assay is a real-time RT-PCR test capable of providing results in just over an hour. “Our proprietary NeuDry™ technology further enables efficient automation of the NeuMoDx™ SARS-CoV-2 Assay, as all reagents and consumables do not require refrigeration and are provided in “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’ – with the first result available in about 80 minutes for the SARS-CoV-2 Assay.  These innovative analyzers 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.

NeuMoDx™ is submitting the assay for Emergency Use Authorization (EUA) in the US and will immediately make a Research Use Only (RUO) version of its test available at no-charge to qualified US laboratories to gain experience with the test in advance of EUA.  Additionally, the NeuMoDx™ systems allow laboratories to efficiently validate their own SARS-CoV-2 Laboratory Developed Tests on the system, including those provided by WHO and the CDC, in order to immediately improve throughput and increase the volume of testing. NeuMoDx™ will also provide access to RUO tests in countries where allowed and is seeking CE Marking for its SARS-CoV-2 Assay.  “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.”

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.

To learn more about SARS-CoV-2 testing, click here.
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