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Diagnostics FDA

 News Release - July 22, 2020

Luminex Files for Emergency Use Authorization for Expanded NxTAG Respiratory Panel Test Including SARS-CoV-2

Syndromic testing will streamline respiratory infection diagnosis as COVID-19 pandemic collides with start of flu season

AUSTIN, Texas, July 22, 2020 -- (Healthcare Sales & Marketing Network) -- Luminex Corporation (NASDAQ: LMNX) today announced that it has submitted an EUA request to the FDA for a new expanded version of its NxTAG® Respiratory Pathogen Panel (RPP) to include the SARS-CoV-2 virus for high-throughput COVID-19 testing. The new test is a combination of the company's original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing, and the most relevant circulating pathogen today, SARS-CoV-2.

Respiratory infections such as COVID-19 and influenza can be challenging to differentiate and diagnose accurately because they feature many of the same symptoms. NxTAG RPP is a multiplex, high-throughput test designed to enable simultaneous detection of the most common respiratory pathogens for a fast, syndromic testing approach. With the addition of the SARS-CoV-2 virus, the panel now includes 19 viral and 2 bacterial targets, combining the most common respiratory pathogens in one panel to help facilitate the rapid identification of various individual and co-occurring infectious pathogens.

NxTAG RPP provides scalable throughput, allowing clinical labs to run up to 96 samples at a time and generate results in approximately four hours with minimal hands-on time. The test runs on Luminex's easy-to-use, compact MAGPIX® System and is designed for use in high-complexity molecular laboratories.

"Clinical laboratories are straining under the pressure of COVID-19 testing, and the unfortunate reality is that even in these incredibly challenging conditions, labs must now look ahead to the coming flu season," said Nachum "Homi" Shamir, President and CEO of Luminex. "We believe that syndromic respiratory testing will be a critical tool for dealing with the seasonal flu outbreak that is coming on top of a global pandemic. We incorporated the SARS-CoV-2 virus into our trusted NxTAG RPP panel to alleviate laboratory capacity constraints and improve the ease of testing."

Since the start of the COVID-19 pandemic, Luminex has focused on expanding capacity for SARS-CoV-2 diagnostic testing across all of its molecular platforms. The company previously launched the NxTAG CoV Extended Panel under an EUA from the FDA and an Authorization for Import or Sale with Conditions from Health Canada, and also received FDA EUA for its ARIES® SARS-CoV-2 Assay. Earlier this month, the company announced it had received FDA EUA for its xMAP® SARS-CoV-2 Multi-Antigen Immunoglobulin G (IgG) Assay, a new serology test that can be run on any of Luminex's xMAP-based high-throughput, gold-standard multiplex platforms. The test detects IgG antibodies, which are an important component of an adaptive immune response and typically reflect sustained immunity to a given pathogen.

The NxTAG CoV Extended Panel and the ARIES® SARS-CoV-2 Assay have each been funded with $642,450 of Federal funds, approximately 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 under Contract Nos. 75A50120C00037 (NxTAG CoV Extended Panel) and 75A50120C00043 (ARIES® SARS-CoV-2 Assay). Luminex financed the remaining $1,118,663 of each program, constituting 64% each of the total program costs.

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 of products to address the novel coronavirus. Such statements involve a number of risks and uncertainties. Words such as "can," "will," "believe," "provide," "allows," 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.


Source: Luminex

Issuer of this News Release is solely responsible for its content.
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