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- Follows BARDA Contract and EUA for NxTAG® CoV Extended Panel last week
- ARIES® SARS-CoV-2 Assay will be submitted for EUA later this week
AUSTIN, Texas, March 31, 2020 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced that it has received $642,450 in funding from the Biomedical Advanced Research and Development Authority (BARDA). These funds will help support development, testing, and submission later this week for an Emergency Use Authorization (EUA) for the ARIES® SARS-CoV-2 Assay. This assay will run on the company's sample-to-answer ARIES® System, an FDA-cleared, automated molecular diagnostics platform for moderate complexity labs.
The ARIES® SARS-CoV-2 Assay is designed to provide rapid answers in patients believed to have COVID-19, generating results in approximately two hours. It can be run on 6-unit and 12-unit ARIES® Systems for labs seeking a medium-throughput solution with minimal hands-on time required. The assay will improve upon existing laboratory-developed tests (LDTs) for SARS-CoV-2 on the ARIES® System by eliminating the need to purchase and incorporate additional reagents, making the test easier to run and allowing labs to start testing immediately upon performance verification. Luminex intends to price the ARIES® SARS-CoV-2 Assay below current government reimbursement levels in order to prevent additional financial burden on customers and the healthcare system during the COVID-19 pandemic.
BARDA is part of the US Department of Health and Human Services and is tasked with protecting the country against emerging infectious diseases and other threats. Through public-private partnerships, BARDA supports the development of vaccines, drugs, and diagnostics.
"Throughout this challenging time, the Luminex team has been laser-focused on contributing to the global response to the COVID-19 global outbreak," said Nachum "Homi" Shamir, President and CEO of Luminex. "We thank BARDA for supporting our efforts to develop and quickly launch this new test and our recently EUA-cleared NxTAG CoV Extended Panel. Luminex is now on a run-rate to deliver up to 500,000 tests per month, which are primarily focused on helping our customers fight this global pandemic."
Luminex received a BARDA contract and an FDA EUA last week for its new NxTAG CoV Extended Panel, a high-throughput test for detecting SARS-CoV-2 that provides results for up to 96 samples in approximately four hours. The NxTAG CoV Extended Panel runs on Luminex's easy-to-use, compact MAGPIX® System.
These projects have been funded at approximately 36% each 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 Nos. 75A50120C00037 (NxTAG CoV Extended Panel) and 75A50120C00043 (ARIES® SARS-CoV-2 Assay).
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, as well as other statements that refer to future plans and expectations, particularly around the development of products to address the novel coronavirus. Such statements involve a number of risks and uncertainties. Words such as "expect," "believe," "quickly," "will," "expected," "designed," "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.
Sr. Vice President of Finance and CFO
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SOURCE Luminex Corporation