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Luminex Gains EUA for Diagnostics as Demand for COVID-19 Tests Soars

The Austin TX-based company was granted Emergency Use Authorization for the Aries SARS-CoV-2 Assay and the NxTAG CoV Extended Panel to help in the detection of the novel coronavirus.

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Luminex can be added to the list of companies that have received Emergency Use Authorization (EUA) for a diagnostic to address the coronavirus (COVID-19) pandemic.

The Austin, TX-based firm was granted the designation for the Aries SARS-CoV-2 Assay for the rapid detection of the virus that causes COVID-19. The assay runs on the Aries System, which is cleared by FDA and has the capability of running up to 144 tests per day.

Recently Luminex received another EUA in addition to Medical Device Authorization for importation or sale for Health Canada for the NxTAG CoV Extended Panel. The company said the panel is a high-throughput, scalable, cost-effective option for detecting SARS-CoV-2 in as many as 96 samples in approximately four hours.

Currently, the demand for COVID-19 tests in the U.S. is off the charts. NPR recently reported that some companies are facing a backlog in getting samples tested.

Eric Shapiro, VP of global marketing, Luminex said that even though there were tests constantly coming to the market there was still room for new tests.

“There’s not enough capacity to fit the demand,” Shapiro told MD+DI. “So, every company that’s out there right now that can help to fill this demand is important.”

In a release Luminex said the NxTAG CoV Extended Panel and the Aries SARS-CoV-2 Assay have each been funded with $642,450 of Federal funds, about 36% each of the expected overall cost of development, from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures.

The company financed the remaining $1,118,663 of each program, constituting 64% each of the total program costs.

“I think what makes Luminex unique in this is we have the ability to test for COVID-19 with the panel we put out, but also to test for 20 other respiratory pathogens with the same system,” Shapiro said. “You have patients who could come in with either flu or other respiratory complications or COVID-19, or both, or neither. And the ability to differentiate what that patient has, quickly allows the physician to determine if they need to treat them; if they have to isolate them; or they need to send them home. It helps determine what is the appropriate treatment and getting it right the first time is so critical right now.”

Most recently Abbott Laboratories made a big splash with its new ID NOW COVID-19. The assay was displayed during President Donald Trump’s COVID-19 taskforce press briefing on March 30.

The test is Abbott’s second to receive FDA’s EUA for COVID-19 virus detection. The first was Abbott’s RealTime SARS-CoV-2 EUA test for use on its molecular laboratory instrument, the m2000 RealTime System.

The influx of tests isn’t causing the market to be crowded Luminex executives said. But what is happening is companies should begin looking at the lessons that can be learned from the pandemic. Joern Mosener, VP of Assay R&D and clinical affairs of Luminex, noted that biosurveillance is going to be a key point moving forward.

“That means that we as a diagnostic industry have to ensure that on a constant basis, we monitor the viruses that materialize out there and also update our tests more quickly if something new shows up,” Mosener told MD+DI.

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