Luminex Corporation Submits VERIGENE® II Respiratory Flex Assay for FDA Clearance
AUSTIN, Texas, Feb. 24, 2020 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced that the company has submitted an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of the VERIGENE® II Respiratory Flex Assay, the second VERIGENE II assay to be submitted to the agency. The VERIGENE® II Respiratory Flex (RSP Flex) Assay is a multiplexed, qualitative test for simultaneous detection and identification of common viruses and bacteria from nasopharyngeal swabs that are obtained from individuals suspected of respiratory tract infection.
This assay, along with the Gastrointestinal (GI) Flex Assay, both run on Luminex's new VERIGENE II system. The GI Flex Assay is an automated test for the detection and identification of enteric bacteria, viruses, parasites, and toxins in stool samples. Both are now under review with the FDA, and Luminex anticipates launching the new VERIGENE II assays mid-year.
"We are delivering on our strategy and our promise to expand the menu of clinically relevant, high-value tests that accelerate and simplify diagnostic testing," said Homi Shamir, President and CEO of Luminex. "We're also demonstrating once again the cost-effectiveness of rapid testing on a Luminex platform. The flexibility of the automated VERIGENE II System uniquely allows clinical laboratories to select, test and pay for only the targets ordered for each patient. This is a game-changer for many laboratories."
The VERIGENE II System is a benchtop molecular diagnostic system that uses advanced automation and specialized chemistry to enable rapid, sample-to-result detection. The RSP Flex Test is performed on this system utilizing reverse transcription, polymerase chain reaction, and array hybridization to detect specific respiratory viral and bacterial pathogen nucleic-acid gene sequences.
"By expanding the foundational assays on our next-generation VERIGENE system to a wider variety of common viruses and bacteria, we are helping laboratories deliver fast, accurate results and are streamlining the process of sample testing," said Shamir.
When targeted therapies depend on clinical test results, testing of nasopharyngeal samples for specific pathogens is highly useful, especially given that respiratory tract infections (RTIs) are among the three most common acute illnesses evaluated in outpatient care.1 Children are particularly vulnerable to RTIs, with an average of six per year.2 If these illnesses are not diagnosed accurately or quickly enough, they can lead to more serious illness and, in severe cases, to increased childhood mortality. The VERIGENE II RSP Flex Assay delivers a critical test that is designed to address this widespread and costly challenge.
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
Statements made in this release that express Luminex's or management's intentions, plans, beliefs, expectations or predictions of future events are forward-looking statements. Forward-looking statements in this release include statements regarding the available market and customer acceptance for the VERIGENE II Respiratory Flex Assay, VERIGENE II GI Flex Assay, and the VERIGENE® II System. Expressions such as "looking to" are intended to further identify such forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. It is important to note that the Company's actual results or performance could differ materially from those anticipated or projected in such forward-looking statements. Factors that could cause Luminex's actual results or performance to differ materially include risks and uncertainties relating to, among others, market demand and acceptance of Luminex's products and technology; Luminex's ability to obtain and enforce intellectual property protections on Luminex's products and technologies; Luminex's ability to successfully launch new products in a timely manner; competition and competitive technologies utilized by Luminex's competitors; as well as the risks discussed under the heading "Risk Factors" in Luminex's Reports on Forms 10-K and 10-Q, as filed with the Securities and Exchange Commission. The forward-looking statements contained herein represent the judgment of Luminex as of the date of this press release, and Luminex expressly disclaims any intent, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in Luminex's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Investor Contacts:
Harriss Currie, 512.219.8020
Sr. Vice President of Finance and CFO
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Jeff Christensen, 512.249.3033
Senior Director, Investor Relations
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Media Contact:
Michele Parisi, 925.864.5028
Bioscribe
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1 Micah T. and Bomar P. Upper Respiratory Tract Infection. December 16, 2019. Accessed February 18, 2020. https://www.ncbi.nlm.nih.gov/books/NBK532961/
2 Tesini, B.L. Overview of Viral Respiratory Tract Infections in Children. Merck Manual. September 2019. Accessed February 18, 2020. https://www.merckmanuals.com/home/children-s-health-issues/viral-infections-in-infants-and-children/overview-of-viral-respiratory-tract-infections-in-children
SOURCE Luminex Corporation
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