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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.

IMPORTANT ANNOUNCEMENT

We are excited to announce that QIAGEN has acquired all shares of NeuMoDx Molecular, Inc. The addition of NeuMoDx’s medium- and high-throughput molecular systems further expands QIAGEN’s portfolio of molecular diagnostics instruments, bolstering our leadership in automated molecular testing. We are proud to welcome NeuMoDx to our family of PCR solutions that make improvements in life possible.

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