Genetic Assays, Inc. Rolls Out FDA-Approved Respiratory Viral Panel Just In Time For Flu Season

Nashville, TN (PressExposure) October 20, 2008 -- In an effort to help clinicians improve patient care and save lives through rapid diagnosis of disease, Genetic Assays, Inc. (GA) is offering a new lab test to hospitals and medical centers — the xTagTM Respiratory Viral Panel (RVP) from Luminex Molecular Diagnostics. The RVP is a groundbreaking test that provides qualitative results for the presence or absence of the following 12 infectious respiratory viruses and viral subtypes from a single patient sample: • Adenovirus • Human Metapneumovirus (hMPV) • Influenza A • Influenza A subtype H1 • Influenza A subtype H3 • Influenza B • Parainfluenza 1 • Parainfluenza 2 • Parainfluenza 3 • Respiratory Syncytial Virus (RSV) A • Respiratory Syncytial Virus (RSV) B • Rhinovirus.

The results of this multiplex assay will be particularly useful to emergency room physicians, pulmonologists, infectious disease physicians, and critical care doctors. The target beneficiaries of the RVP include patients in adult, pediatric, and neonatal intensive care units, as well as geriatric patients in nursing homes.

Mike Mammarelli, Chairman, President, and CEO of Genetic Assays, Inc. says, "Multiplex molecular diagnostics is paving the way for great advancements in patient care within the clinical laboratory industry. We at Genetic Assays are excited about the opportunity to be the first laboratory within our markets to offer the simultaneous detection and identification of 12 leading respiratory viruses. Patients from all walks of life, ranging from newborn to elderly, will benefit from this testing. The release of this new test offering should coincide well with the advent of flu season."

In June 2008, the Centers for Disease Control and Prevention (CDC) reported that the 2007-2008 flu season was worse than the previous two. Deaths attributed to pneumonia and flu exceeded the CDC's statistical epidemic threshold for a consecutive period of 19 weeks. The number of patient visits to healthcare providers for treatment of influenza and respiratory illness surpassed national baseline levels from late December 2007 to late March 2008.1

When an ailing patient visits a healthcare provider with an unknown respiratory infection, the RVP results provided by Genetic Assays will be able to meet the vital need for increased sensitivity and decreased diagnosis time. The panel is able to simultaneously detect 12 viruses in as little as 24 hours at sensitivity levels over 90 percent, as compared to conventional testing which typically takes 2-8 weeks to show results. These advantages are of particular importance when hard-to-culture organisms are involved. Furthermore, the RVP is the first test cleared to differentiate between H1 and H3 subtypes of Influenza A. This new multiplex assay is also the first test to detect human metapneumovirus, a leading cause of respiratory infection in children.

Many symptoms of respiratory disease are shared, so it can be difficult to determine whether a bacteria or virus, and which specific virus, is the cause. As Paul Dahlhauser, GA’s Director of Research and Laboratory Services elaborates, “Since the qualitative results of the RVP cover more than 85 percent of respiratory viral infections, it enables physicians to provide appropriate treatment while preventing inappropriate use of antibiotics.”

About Genetic Assays: Genetic Assays is a molecular diagnostics reference laboratory, incorporated and licensed by the State of Tennessee since 1994. Possessing a CLIA certificate of accreditation, GA is a high-complexity DNA testing facility that has performed hundreds of thousands of molecular tests since its inception. This genetic technology company offers physicians, hospitals, and laboratories the most advanced molecular techniques for the gene level diagnosis and management of disease. Services are focused on the disciplines of Molecular Biology and Pathology. For more information about xTagTM Respiratory Viral Panel (RVP), please see or phone Genetic Assays at (800) 390-5280.

(1) Centers for Disease Control. Accessed 8 October 2008.

Press Release Submitted On: October 17, 2008 at 7:27 pm
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