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Luminex Submits Verigene II Respiratory Assay for FDA Clearance

NEW YORK – Luminex announced Monday that it has applied to the US Food and Drug Administration for 510(k) clearance of the Verigene II Respiratory Flex Assay (RSP Flex), a multiplexed test for simultaneous detection and identification of common viruses and bacteria from nasopharyngeal swabs obtained from a person suspected of having a respiratory tract infection.

The RSP Flex Test uses reverse transcriptase, polymerase chain reaction, and array hybridization to detect specific nucleic-acid gene sequences associated with respiratory viral and bacterial pathogens. The assay runs on Austin, Texas-based Luminex's Verigene II system, a benchtop molecular diagnostic system that uses automation and specialized chemistry to enable rapid, sample-to-result detection.

In the fourth quarter of last year, Luminex also applied to the FDA for clearance of its Gastrointestinal Flex Assay for the detection and identification of enteric bacteria, viruses, parasites, and toxins in stool samples.

Luminex said it anticipates launching the system and assays in the middle of this year.

Luminex President and CEO Nachum Shamir said in a statement that 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."