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US FDA Grants Clearance For An Update To The Luminex’s xTAG Respiratory Viral Panel Package Insert

Luminex Corporation announced that the company received clearance for an update to the xTAG Respiratory Viral Panel Package Insert. The labeling updates include data about the performance of the test in humans infected with the pandemic strain of influenza A, 2009 influenza A/H1N1 that is sometimes referred to as “swine flu.” The test’s labeling has been updated so as to include information from two new studies which demonstrate that xTAG RVP can be an effective aid to detect 2009 Influenza A/HIN1, but cannot identify the hemagglutinin gene of the 2009 Influenza A/H1N1 in clinical specimens.

“The studies referenced in the xTAG RVP package insert demonstrate that the test can help determine if a patient is carrying a typical, seasonal respiratory virus or an unsubtypeable flu A virus,” said Patrick J. Balthrop, president and chief executive officer of Luminex. “The xTAG RVP test can be a critical first line of defense in virus surveillance and in separating patients with more common respiratory infections from novel cases.”

The study was led by Dr. Christine Ginocchio, Director of Microbiology, Virology and Molecular Diagnostics at North Shore-LIJ Health System Laboratories. The studies were entitled Evaluation of Multiple Test Methods for the Detection of the Novel 2009 Influenza A (H1N1) during the New York City Outbreak” and “Likelihood that an unsubtypeable Influenza A result in the Luminex xTAG Respiratory Virus Panel is indicative of novel A/H1N1 (swine-like) influenza.”

In January 2008, xTAG RVP was first cleared by the FDA. It is a commercially available test that can simultaneously detect 12 respiratory viruses and subtypes which include influenza A with subtyping at the DNA/RNA level. xTAG RVP was designed to detect the matrix gene which is shared across several influenza A strains, including 2009 influenza A/H1N1. It detects the hemagglutinin gene of seasonal strains of H1N1 and H3N2. The design enables xTAG RVP to provide 3 types of results for patients infected with influenza A: 1) influenza A-H1; 2) influenza A-H3; 3) influenza A-unsubtypeable.

xTAG RVP is available in the US through Luminex Molecular Diagnostics, Abbott Laboratories and Fisher HealthCare. It is available globally from Luminex Molecular Diagnostics and Abbott Laboratories