Luminex Corporation 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.
