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HomeFDALuminex Corporation Submits VERIGENE® II Respiratory Flex Assay for FDA Clearance

Luminex Corporation Submits VERIGENE® II Respiratory Flex Assay for FDA Clearance

The company reports 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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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