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Luminex Shares Rise on Third FDA EUA for Coronavirus Tests

NEW YORK ─ The US Food and Drug Administration on Thursday granted Emergency Use Authorization to Luminex for its xMap SARS-CoV-2 Multi-Antigen IgG Assay, which detects IgG antibodies against SARS-CoV-2 on the Luminex 200, Magpix, Magpix NxTag-enabled, and Flexmap 3D systems.

In afternoon trading on the Nasdaq Friday, Luminex shares rose more than 7 percent on the news to $37.11 and dropped to $36.28 at the close of trading.

The xMap SARS-CoV-2 Multi-Antigen IgG Assay is a multiplexed microsphere test that measures the presence of IgG antibodies against the SARS-CoV-2 S1 subunit of the spike protein, the receptor-binding domain of the spike protein, and the nucleocapsid protein in serum or plasma samples.  

The product identifies people with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

The xMap SARS-CoV-2 Multi-Antigen IgG Assay delivers results for up to 96 patient samples in less than three hours, Luminex said. In clinical studies, the assay demonstrated specificity of 100 percent in human serum and greater than 99 percent in human plasma, with sensitivity greater than 96 percent for both human serum and plasma greater than 14 days after symptom onset.

"More than 17,000 xMap systems have been sold to laboratories around the world, and this FDA authorization creates important new opportunities for these labs to rapidly expand their COVID-19 testing capabilities with a highly accurate serology-based assay," Nachum Shamir, president and CEO of Luminex, said in a statement.

The company said its SARS-CoV-2 Multi-Antigen IgG Assay is the first of several serology tests that it is developing and plans to take to market through an EUA to help during the COVID-19 crisis.

It is the third assay developed by Austin, Texas-based Luminex to receive EUA to detect the coronavirus.

In April, Luminex received EUA for its Aries SARS-CoV-2 Assay, which runs on its sample-to-answer molecular diagnostic Aries platform. In March, the firm received EUA for its NxTag CoV Extended Panel that detects SARS-CoV-2 virus nucleic acids in nasopharyngeal swab specimens and runs on the Magpix system.

In early morning trading on the Nasdaq Monday, shares of Luminex were up more than 2 percent at $37.03.