Luminex Corporation Submits VERIGENE(R) II Respiratory Flex Assay for FDA Clearance

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.

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