Luminex Corporation announced today 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 has the potential to significantly change the way respiratory viral testing is performed and 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 as the market leader in providing comprehensive 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), Influenza A, Non-specific influenza A, H1 subtype, H3 subtype, Influenza B, Metapneumovirus (hMPV), Adenovirus and Entero-Rhinovirus.
With minimal hands-on-time from laboratory staff, xTAG RVP FAST offers clinical and diagnostic laboratories the ability to rapidly provide actionable patient results to physicians. In addition to cost and time savings for the laboratory, earlier detection and differentiation between viral and bacterial infections facilitate appropriate physician treatment decisions, improving patient care and helping to reduce healthcare costs.
"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 we are pleased to provide a range of testing options that meet our customers' needs and ultimately improve healthcare for patients worldwide."
In addition to xTAG RVP FAST, Luminex's growing family of molecular diagnostic products for infectious diseases include:
xTAG RVP which received FDA approval in January 2008 as the first respiratory viral panel testing for 12 viruses including H1N1 and was awarded the 2010 Prix Galien Award for Best Medical Technology.
xTAG Gastrointestinal Pathogen Panel (GPP) which received CE mark approval in May 2011 and was recently used as a first-line screen in the management of the E. coli outbreak in Europe.
MultiCode-RTx Herpes Simplex Virus (HSV) 1&2, the first FDA approved PCR-based qualitative test for detection and typing of HSV-1 or HSV-2.
The xTAG RVP FAST panel is built on the versatile Luminex® 100/200(TM) platform that makes available a broad menu of applications and will be commercially available from Abbott Molecular Diagnostics and Fisher Healthcare.