Luminex Receives BARDA Funding to Support Development and Validation of Test Combining SARS-CoV-2 and Flu/RSV Respiratory Panel

Rhea-AI Summary

Luminex Corporation (NASDAQ: LMNX) has secured $11.3 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to develop a respiratory panel test. This test will simultaneously detect Flu A/B, RSV, and SARS-CoV-2, which is crucial for clinical labs facing increased demand for respiratory illness testing. The ARIES® Systems can deliver results in under two hours, reducing the workload on labs. Luminex plans to request Emergency Use Authorization from the FDA for the new assay, enhancing their portfolio in the ongoing fight against respiratory diseases.

Positive

• Secured $11.3 million funding from BARDA.
• Development of a new respiratory panel test that combines Flu A/B, RSV, and SARS-CoV-2.
• ARIES® Systems will provide results in less than two hours, improving laboratory efficiency.

Negative

• None.

AUSTIN, Texas, Feb. 19, 2021 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced that it has received $11.3 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. These funds will support the rapid development and validation of a respiratory panel combining Flu A/B & respiratory syncytial virus (RSV) targets with the SARS-CoV-2 target that can be run on all ARIES^® Systems. These 6- and 12-cassette systems are automated molecular diagnostic platforms used in moderate- and high-complexity labs with a number of FDA cleared tests already available for use on them. The systems produce results in less than two hours with minimal hands-on time required.

Clinical labs already challenged by continued COVID-19 testing are now under additional pressure to simultaneously meet the testing demand associated with seasonal flu and RSV, whenever these pathogens are in circulation at the same time. These respiratory illnesses can cause symptoms similar to COVID-19, making it difficult for physicians to distinguish between them. A single test that can simultaneously detect these pathogens would allow clinical labs to get more complete answers quickly, while using fewer reagents and other consumables, easing pressure on an already stressed supply chain.

"We believe that this targeted multiplex assay will play a pivotal role in helping healthcare professionals efficiently and effectively manage individuals with respiratory illness symptoms for years to come," said Nachum "Homi" Shamir, Chairman, President and CEO of Luminex. "We are grateful to BARDA for its continued support as we seek to streamline respiratory testing with a single assay for the most common pathogens. This will allow laboratories, most of which are already operating in resource-constrained environments, to run one test instead of two or more without sacrificing clinical results."

Luminex developed the original ARIES^® SARS-CoV-2 (EUA) Assay with financial support from BARDA in 2020.

Luminex will submit the targeted multiplex respiratory panel, the ARIES^® Flu A/B & RSV+SARS-CoV-2 Assay, to the FDA for Emergency Use Authorization as soon as possible, and eventually plans to submit the panel for 510(k) clearance as well.

This project has been funded in whole or in part 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 under Contract No. 75A50121P00025.

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. To learn more about Luminex's COVID-19 Testing and Research Solutions, please visit: https://www.luminexcorp.com/solutions/.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements relating to Luminex's business outlook for the first quarter, as well as other statements that refer to future plans and expectations, particularly around the development of products to address COVID-19. Such statements involve a number of risks and uncertainties. Words such as "expect," "believe," "confident," "unable," "seem," "would," "should," "could," "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 Relations Contact:
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

 

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SOURCE Luminex Corporation

FAQ

What is the recent funding amount Luminex received from BARDA?

Luminex Corporation received $11.3 million from BARDA.

What will the new respiratory panel test by Luminex detect?

The test will detect Flu A/B, RSV, and SARS-CoV-2.

How quickly can the ARIES® Systems provide results for the new test?

The ARIES® Systems can deliver results in under two hours.

What is the significance of the funding for Luminex?

The funding will support the development and validation of a critical respiratory illness testing solution.

When does Luminex plan to submit the new respiratory panel for FDA approval?

Luminex plans to submit the panel for Emergency Use Authorization as soon as possible.