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Biotechnology company Luminex has received the US Food and Drug Administration’s (FDA) emergency use authorisation (EUA) for its NxTAG CoV Extended Panel test intended to detect SARS-CoV-2 virus that causes Covid-19.
High-complexity molecular laboratories will be able to diagnose up to 96 patients in almost four hours with the NxTAG test on the company’s compact MAGPIX System that uses bead-based chemistry.
Furthermore, the test can be run in parallel with the NxTAG Respiratory Pathogen Panel (RPP) to deliver a complete picture of a patient’s respiratory health.
Luminex president and CEO Nachum 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 the price below government reimbursement levels to make testing more affordable for our customers and the healthcare system.”
Currently, the company is supporting laboratories in the US, Asia, and Europe with the testing. It has scaled up the manufacturing capacity to produce up to 300,000 NxTAG tests a month.
Earlier this week, the Biomedical Advanced Research and Development Authority (BARDA) granted $642K in funding to Luminex to develop and validate the NxTAG SARS-CoV-2 test.
Meanwhile, the US is witnessing an increase in coronavirus cases and related deaths. According to the latest reports, the death toll has reached 2,513, while the number of confirmed cases stands at 143,055.