FDA Clearance for Respiratory Viral Panel that Simultaneously Detects 12 Viruses

Luminex Corporation has received 510(k) clearance from the FDA for its xTAG™ Respiratory Viral Panel (RVP). xTAG RVP is the first FDA-cleared assay to simultaneously detect and identify 12 viruses and viral subtypes that together are responsible for more than 85 percent of respiratory viral infections.


xTAG RVP is a groundbreaking test that, with a single patient sample, can assess the presence or absence of 12 viral targets and provide qualitative results in a few hours.

The speed and reliability of xTAG RVP will help physicians provide appropriate treatment, and prevent inappropriate antibiotic use.


With a non-invasive, painless swab, xTAG RVP tests for:

-- Influenza A, influenza A-H1, influenza A-H3 and influenza B, which cause the majority of flu cases in the U.S.;


-- Adenovirus, which is responsible for approximately 10 percent of respiratory infections and a subtype of which the Centers for Disease Control (CDC) have recently identified as causing
multiple deaths;


-- Respiratory syncytial virus (RSV) A and B, the most common cause of bronchiolitis and pneumonia in infants and children;


-- Metapneumovirus, a recently-discovered virus that causes flu-like symptoms and is thought to be the second leading cause of respiratory infection in children;


-- Parainfluenza 1, 2, and 3, which can cause upper or lower respiratory infections in adults and children and, are thought to be responsible for about half of croup cases and 10-15
percent of bronchiolitis and bronchitis cases; and


-- Rhinovirus, which causes the common cold.


Created by Luminex Molecular Diagnostics in Toronto, and built on Luminex's flexible xMAP technology, xTAG RVP represents a number of 'firsts.' It is the first multiplexed nucleic acid test for respiratory viruses cleared for in vitro diagnostic use by the FDA. It also is the first test of any kind cleared to detect human metapneumovirus, the first test cleared for influenza A subtyping, and the first molecular test cleared for adenovirus.


'Because the symptoms of respiratory disease overlap tremendously, it can be very difficult to determine whether an illness is caused by a virus, and if so, which specific virus, or bacteria,' said Christine C. Ginocchio, Ph.D., Director, Microbiology/Virology and Molecular Diagnostics at North Shore-LIJ Health System Laboratories. 'The xTAG RVP provides results on a broad range of viral pathogens, which will assist in the diagnosis of respiratory infections and help physicians recommend the appropriate treatment quickly. The test also tells us what types of viruses are circulating in our communities, which can assist physicians and public health officials in preventing outbreaks.'


xTAG RVP's unique ability to detect influenza A subtypes H1 and H3 will allow it to play an important role in the pandemic influenza monitoring plans of the U.S. Department of Health and Human Services and the World Health Organization. The test will allow public health officials to distinguish H1 and H3 subtypes, which represent the vast majority of Influenza A subtypes, from rarer subtypes. This way, the few samples that do test positive for Influenza A but cannot be identified as H1 nor H3 subtypes can be flagged for further investigation by the CDC or local public health labs.