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Luminex Receives BARDA Award to Support Enhancement of COVID-19 Multiplex Antibody Test

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Luminex Corporation (NASDAQ: LMNX) has received a $683,500 award from the Biomedical Advanced Research and Development Authority (BARDA) to enhance its xMAP® SARS-CoV-2 Multi-Antigen IgG Assay. This assay detects antibodies for three viral antigens to evaluate previous SARS-CoV-2 infections and immune responses. With a specificity of 100% and sensitivity over 96%, Luminex plans to apply for Emergency Use Authorization upon project completion. This initiative supports communities in understanding immunity levels as they navigate COVID-19.

Positive
  • Award of $683,500 from BARDA enhances product development.
  • Enhanced xMAP assay will consolidate antibody detection for better immune response assessment.
  • High specificity (100%) and sensitivity (>96%) contribute to reliable testing.
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  • None.

AUSTIN, Texas, Sept. 23, 2020 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced that it has received an award of $683,500 from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, to support the enhancement of the company's xMAP® SARS-CoV-2 Multi-Antigen IgG Assay. The company intends to submit this enhanced serology assay for an Emergency Use Authorization when this project is completed.

The xMAP SARS-CoV-2 Multi-Antigen IgG Assay detects antibodies to three different viral antigens—the spike protein, nucleocapsid, and receptor-binding domain—to assess if a person has been infected with SARS-CoV-2. In this new BARDA-funded project, information from all three of these antigens will be integrated to provide a more comprehensive view of a person's immune status. By combining all of this information in one assay, Luminex seeks to create a test that not only identifies prior infection, but also assesses the neutralizing activity of the immune response.

This information is more important than ever with millions of confirmed cases of COVID-19 around the world, and the first proven cases of reinfection having already occurred. As people return to work, students head back to school, and vaccines become available, communities will need to understand the extent to which past infections provide protection against future SARS-CoV-2 infections.

"Throughout the COVID-19 crisis, we have sought to develop tests based on the latest research and the most immediate clinical needs. In addition to our SARS-CoV-2 tests that detect active coronavirus infections, we believe that advanced serology assays will be instrumental in understanding who has been infected," said Nachum "Homi" Shamir, Chairman, President and CEO of Luminex. "We appreciate BARDA's support as we continue to develop solutions that can help improve patient outcomes during this global pandemic."

The currently available xMAP SARS-CoV-2 Multi-Antigen IgG Assay delivers high-quality results for up to 96 patient samples in less than four hours. The assay has 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 (more than 14 days post-symptom onset) in clinical studies. The assay, which can be run on any of Luminex's xMAP-based high-throughput platforms, uses advanced multiplexing capabilities to reduce the risk of false positives and false negatives. The U.S. Food and Drug Administration granted Emergency Use Authorization for this assay on July 20, 2020.

This project has been funded at approximately 37% of the expected overall cost of development with Federal funds 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 under Contract No. 75A50120C00179.

About Luminex Corporation
At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at luminexcorp.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements relating to Luminex's business outlook for the third quarter, as well as other statements that refer to future plans and expectations, particularly around the development or enhancement of specific products to address the novel coronavirus. Such statements involve a number of risks and uncertainties. Words such as "believe," "will," "can" and variations of such words and similar expressions are intended to identify forward-looking statements. Statements that refer to or are based on estimates, forecasts, projections, uncertain events or assumptions, and anticipated trends in our businesses or the markets relevant to them, also identify forward-looking statements. Such statements are based on management's expectations as of the date they were first made and, except as required by law, Luminex disclaims any obligation to update these statements to reflect future events or circumstances. Forward-looking statements involve many risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from the company's expectations include changes in market conditions, supply constraints and other disruptions, changes in capital requirements, and other factors set forth in Luminex's most recent Annual Report on Form 10-K filed with the SEC and available at Luminex's website at www.luminexcorp.com and the SEC's website at sec.gov.

Investor Contacts:
Harriss Currie
Sr. Vice President of Finance and CFO
hcurrie@luminexcorp.com
512-219-8020

Media Contact:
Michele Parisi
Bioscribe
mparisi@bioscribe.com
925-864-5028

Luminex logo. (PRNewsFoto/Luminex Corporation)

 

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