AUSTIN, Texas, March 4, 2020 /PRNewswire/ -- As the rapidly changing situation associated with the Wuhan coronavirus, now known as SARS-CoV-2, continues to evolve both in the United States and around the world, Luminex Corporation (NASDAQ:LMNX) announced today updates on the company's plans, progress, and capabilities in assisting laboratories to detect and diagnose cases of this novel coronavirus disease (COVID-19).
"We have been working on multiple solutions to augment our NxTAG and ARIES offerings in order to facilitate and automate the detection of SARS-CoV-2," said Nachum "Homi" Shamir, President and CEO of Luminex. "These additional alternatives leverage our globally available instrument platforms and assay technologies. They should be especially helpful to laboratories throughout the United States, given the recently released guidance from the Food and Drug Administration concerning high-complexity testing under CLIA prior to Emergency Use Authorization (EUA) for SARS-CoV-2."
Luminex anticipates making two different solutions available for SARS-CoV-2 testing:
- NxTAG®CoV Expanded Panel. Luminex has developed a unique multiplex panel that addresses the current coronavirus outbreak using its existing bead-based NxTAG Technology. This expanded panel has undergone initial testing using samples at Chinese Center for Disease Control and Prevention (China CDC) locations. Early results seem very promising and the company expects to conclude this testing in the next several days. In addition, Luminex has begun validation in the United States at a number of existing customer facilities. This panel should be available to ship to customers in a few weeks, under the terms of the EUA listed above.
This expanded panel includes three gene targets for SARS-CoV-2 (ORF, E-gene, and N-gene), as well as SARS-CoV and MERS-CoV, and will be the first assay panel globally that will be able to simultaneously test for each of these coronavirus strains. Luminex's NxTAG® Respiratory Pathogen Panel (RPP), which was cleared by the FDA and other worldwide agencies more than four years ago, can be run in parallel with the expanded outbreak panel to identify and/or rule out both existing and novel respiratory infections. The existing RPP test and this new expanded panel are both plate-based, high-throughput, low-cost solutions that run on the MAGPIX® instrument. This combination of assays offers labs an ideal solution for their anticipated high-volume testing of respiratory infections, including both flu and other coronaviruses.
- SARS-CoV-2 Target on ARIES®. In addition, Luminex has evaluated a single-target test on the ARIES® System for SARS-CoV-2. The company has had two European reference labs successfully validate a multi-targeted test using the ARIES® System and are also currently validating the test with customers in the United States. ARIES® uses real-time PCR technology that, when combined with its ability to run laboratory developed tests (LDTs), is ideally suited for situations such as the current pandemic. This SARS-CoV-2 target incorporates the latest U.S. Centers for Disease Control and Prevention (CDC) primer sequences and is currently available to customers who use the ARIES® System. This testing can be validated by qualifying laboratories under the aforementioned EUA path. The ARIES® System currently has seven FDA cleared assays, including Flu A/B & RSV.
"Offering multiple solutions is a key part of Luminex's focus on providing value and flexibility to our current and future customers," said Shamir. "The assays we are working on will assist both laboratories and clinicians that need to detect SARS-CoV-2 on its own, as well as those that may need a more complete picture of potential causes of respiratory infections—including targets that are both common and novel in nature. In addition, Luminex's VERIGENE® RP Flex Test, NxTAG RPP, and ARIES® Flu A/B & RSV assays are all able to provide exclusion testing as laboratories grapple with the emerging COVID-19 situation during the flu/respiratory season. Given the expanding scope of this outbreak, it seems likely that we could be battling COVID-19 for the foreseeable future.
"We are unable to quantify at this time what, if any, material financial impact these efforts will have, and are not making any adjustments to our current expectations. We look forward to providing additional updates as they become available," said Shamir.
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 first 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 "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.
Harriss T. Currie
Sr. Vice President of Finance and CFO
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SOURCE Luminex Corporation