Luminex has secured the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its NxTAG CoV Extended Panel, a diagnostic test intended for the detection of the SARS-CoV-2 virus, which causes COVID-19.

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 for up to 96 patients in approximately four hours.

Luminex said that its MAGPIX System would leverage its advanced bead-based chemistry, and its combination with the NxTAG CoV Extended Panel would provide 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.”

Luminex received $642m funding from BARDA to develop 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 NxTAG CoV 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.”