NeuMoDx Molecular Systems, a sample-to-result diagnostic company based in Ann Arbor, is preparing to launch a fully automated test for SARS-Cov-2, the Coronavirus that has been determined to cause COVID-19 infections.
The test will be for use with the company’s NeuMoDx 288 and 96 Molecular Systems and 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,” says Sundu Brahmasandra, president and COO of NeuMoDx.
Additionally, the NeuMoDx systems allow laboratories to efficiently validate their own SARS-Cov-2 laboratory developed tests on the system, including those provided by the World Health Organization and the Center for Disease Control, in order to immediately improve throughput and increase the volume of testing. NeuMoDx also will provide access to RUO tests in countries where allowed and is seeking European Economic Area certification for its SARS-Cov-2 Assay.
NeuMoDx is submitting the test, for emergency use authorization (EUA) in the U.S. and will immediately make a research use only (RUO) version of its test available at no-charge to qualified U.S. laboratories to gain experience with the test in advance of EUA.
“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.”
In other Coronavirus news, the U.S. Department of Health and Human Services’ CDC has awarded Michigan $15.3 million to supports its response to the virus. The funds were part of a total $560 million sent to state and local jurisdictions across the country.
“Our state, local, tribal, and territorial public health partners are on the front lines of the COVID-19 response,” says Dr. Robert R. Redfield, director of the CDC. “The action we are taking today will continue to support their efforts to increase public health capacity where it’s needed most. These funds will allow public health leaders to implement critical steps necessary to contain and mitigate spread of the virus in communities across the country.”
Last week, President Donald Trump signed the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020. The supplemental contains $8.3 billion government-wide, with resources directed for grants or cooperative agreements to states, localities, territories, and tribes to accelerate planning and operational readiness for COVID-19 preparedness and response, as well as develop tools and strategies, provide technical assistance and program support, as well as ensure ongoing communication and coordination among public health agencies and partners throughout the response.