NeuMoDx in Ann Arbor Receives CE Mark Approval for Rapid COVID-19 Test

Ann Arbor’s NeuMoDx Molecular, a molecular diagnostic company offering 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 (COVID-19) implemented on the NeuMoDx Molecular Systems.
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NeuMoDx 288 Molecular System
NeuMoDx Molecular has secured the regulatory CE Mark approval for its COVID-19 test, which can be completed using the NeuMoDx 288 Molecular System (pictured). // Photo courtesy of NeuMoDx Molecular

Ann Arbor’s NeuMoDx Molecular, a molecular diagnostic company offering 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 (COVID-19) implemented on the NeuMoDx Molecular Systems.

The test is a rapid, automated in vitro diagnostic test for the direct detection of SARS-CoV-2 coronavirus RNA from nasopharyngeal, oropharyngeal, or nasal swab specimens from individuals with COVID-19 symptoms.

Hospitals and laboratories can run the test on the high throughput, fully automated NeuMoDx 288 and 96 Molecular Systems, which can provide results in as few as 80 minutes from collection.

“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,” says Sundu Brahmasandra, president and COO of NeuMoDx.

NeuMoDx offers fully automated solutions for molecular diagnosis and provides 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 systems allow laboratories to 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.

“NeuMoDx is committed to employing its technology and resources to join the global effort to limit the continued spread of coronavirus,” says 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.”

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