Luminex Receives U.S. Food and Drug Administration Clearance for xTAG™ Respiratory Viral Panel

Luminex Corporation has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its xTAG™ Respiratory Viral Panel (RVP).

xTAG RVP is said to be 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 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. Traditional testing for this many viruses requires multiple individual diagnostic tests to be performed on a patient sample and can take several days to provide a thorough diagnosis.

Luminex says that the speed and reliability of xTAG RVP will help physicians provide appropriate treatment, and prevent inappropriate antibiotic use that has contributed to the creation of "superbugs."

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.

"The approval of the Luminex xTAG RVP is a critical milestone in the diagnosis, treatment and control of the respiratory viruses that impact millions of individuals every year," said Patrick Balthrop, President and CEO of Luminex.

"In addition to helping improve the surveillance of viruses - both in hospitals and community wide - this test can significantly improve patient care. In a matter of hours, rather than days, xTAG RVP can determine whether a patient has a cold, the flu or another virus, allowing a doctor to prescribe an effective treatment much more quickly," Balthrop continued.