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Luminex Receives FDA Emergency Use Authorization for COVID-19 Diagnostic Panel

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Luminex Corporation has announced that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its NxTAG® CoV Extended Panel. The intended use of this multiplex test is the detection of the SARS-CoV-2 virus. High complexity molecular laboratories can now use the NxTAG test on Luminex’s easy-to-use, compact MAGPIX® System to rapidly detect the virus that causes COVID-19 disease for up to 96 patients in approximately 4 hours. The MAGPIX System, on which the NxTAG panel runs, utilizes Luminex’s unique bead-based chemistry, which makes the system both easy to run and to use. This combination provides a cost-effective testing solution for the rapid delivery of test results.

Luminex responded to the coronavirus outbreak by developing the NxTAG CoV Extended Panel as a high-throughput, scalable, cost-effective option for detecting SARS-CoV-2. To provide a more complete picture of a patient’s respiratory health, the NxTAG CoV Extended Panel can also be run in parallel with the NxTAG® Respiratory Pathogen Panel (RPP). Luminex is actively supporting laboratories in the US, Asia, and Europe with their testing, and the company has expanded its manufacturing capacity to produce up to 300,000 NxTAG tests per month, with the majority of that capacity focused on SARS-CoV-2.

“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,” said Nachum "Homi" Shamir, President and CEO of Luminex. “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.”   

Earlier this week, Luminex received $642K in funding (approximately 36% of the total program cost) through a contract from the Biomedical Advanced Research and Development Authority (BARDA) to develop and validate the NxTAG SARS-CoV-2 Test. “We are grateful to BARDA for reviewing and issuing this contract so quickly,” said Shamir. “Our collaboration has been an important aspect to accelerating the availability of this rapid, high-throughput assay.”