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FDA Clearance for xTAG Respiratory Viral Panel
Luminex Corporation announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its xTAG Respiratory Viral Panel FAST (RVP FAST). This front line test complements the company´s existing respiratory portfolio.
Laboratories and healthcare providers are looking for ways to improve efficiency while managing increasingly complex disease states. The value of multiplexed testing for respiratory viruses is well established with Luminex providing multiplexed testing for respiratory viruses. The addition of xTAG RVP FAST assay to Luminex´s RVP growing product portfolio brings additional testing options to diagnostic laboratories looking for a front line assay targeting eight essential respiratory pathogens and delivering up to 96 patient results in a few hours.
'Providing faster results from a broad panel makes it easier for physicians to quickly identify appropriate treatment. Better patient outcomes have the potential to reduce hospitalizations and the associated burden on the healthcare system,' said Rodney Arcenas, Ph.D., Clinical Scientist, Molecular Microbiology and Immunology for Memorial Healthcare System in Hollywood, Florida. 'A streamlined and scalable assay that produces results in shorter time is important in effectively managing fluctuating patient volumes and seasonal spikes typically associated with respiratory viral illnesses.'
xTAG RVP FAST panel includes:
Respiratory Syncytial Virus (RSV)
Non-specific influenza A H1 subtype H3 subtype
'Clearance of xTAG RVP Fast allows us to provide clinical laboratories with a new diagnostic tool to help manage their patients with influenza-like illness,' said Patrick Balthrop president and CEO of Luminex. 'Luminex is recognized for its leadership in the area of infectious disease multiplexing assays, and particularly in respiratory viral testing and are pleased to provide a range of testing options that meet our customers´ needs and ultimately improve healthcare for patients worldwide.'
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