xTAG Respiratory Viral Panel Gets Clearance for FDA

By Anna Boyd
17:16, January 5th 2008
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xTAG Respiratory Viral Panel Gets Clearance for FDA

The U.S. Food and Drug Administration has approved Thursday a new test that can quickly inform doctors what kind of virus is making patients sick and may reduce the use of unneeded antibiotics as well.

The test identifies 12 respiratory viruses or subtypes, including several types of influenza and rhinovirus-which is known to cause the common cold.

 xTAG Respiratory Viral Panel, on its name, is manufactured by Luminex Corporation, a biological testing company and it is expected to be used by hospitals labs and in private medical practices. Luminex selected ViraCor to be an early adopter reference laboratory for the assay.

"xTAG RVP is a major advancement in respiratory viral testing because it gives doctors fast and accurate results for the nation's most important respiratory viruses. Up until now, clinicians have been playing a guessing game based largely on a patient's symptoms. The high degree of sensitivity and specificity of xTAG RVP helps eliminate incorrect diagnosis by greatly reducing the false negative results that are common with conventional testing methods," said Steve Kleiboeker, Ph.D., Vice President and Chief Scientific Officer of ViraCor Laboratories.

xTAG RVP is a highly sensitive molecular assay able to trace several respiratory viruses which cannot be currently detected by conventional methods, including human metapnemovirus (hMPV), rhinovirus and influenza A subtype H1 and H3. The assay is the most important as the two viruses are known to represent the cause of in excess of 40 percent of respiratory viral infections. They were also difficult for laboratories to detect.

Shares of Luminex jumped to a new annual high Thursday after the new test was cleared. The company’s stock rose 79 cents or 4.9 percent to $17.02. Earlier in the day, the stock hit a 52-week high of $17.87.



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