Luminex has obtained the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its NxTAG CoV extended panel, a test intended for the detection of the SARS-CoV-2 virus.
The new test has been designed for use with the company’s compact MAGPIX System, enabling advanced molecular laboratories to rapidly detect SARS-CoV-2 virus in up to 96 patients in approximately 4 hours.
By utilising the company’s advanced bead-based chemistry, the MAGPIX system offers easy to run and to use features.
As the NxTAG CoV extended panel is run on the system, the combination is expected to offer a cost-effective testing solution for the rapid delivery of test results.
Luminex president and CEO Nachum Homi Shamir said: “We are partnering with our customers at clinical laboratories to address the global pandemic, providing fast, reliable, scalable, multiplexed tests that can help stem the spread of COVID-19 disease, while also ensuring that our tests are cost-effective.
“While there are many companies providing tests that can detect the SARS-CoV-2 strain, to our knowledge Luminex is the only company providing tests that can detect and differentiate between SARS-CoV-2 and the other common respiratory infections, while keeping price below government reimbursement levels to make testing more affordable for our customers and the healthcare system.”
BARDA awarded $642m contract to Luminex for NxTAG SARS-CoV-2 Test
The company has developed the NxTAG CoV extended panel as a high-throughput, scalable, cost-effective option for detecting SARS-CoV-2, amid the outbreak of COVID-19 across the world.
The extended panel is capable of being run in parallel with the NxTAG Respiratory Pathogen Panel (RPP), to offer a complete picture of a patient’s respiratory health.
Luminex claimed that it has expanded its manufacturing capacity to produce up to 300,000 NxTAG tests per month, to help the laboratories in the US, Asia, and Europe to test for SARS-CoV-2.
In addition, the company has secured $642K funding through a contract from the Biomedical Advanced Research and Development Authority (BARDA) to develop and validate the NxTAG SARS-CoV-2 Test.
Shamir added: “We are grateful to BARDA for reviewing and issuing this contract so quickly. Our collaboration has been an important aspect to accelerating the availability of this rapid, high-throughput assay.”
