Medical Milestone by the FDA

January 3, 2008 9:00:00 PM PST
The FDA is clearing the way for a test that could detect the viruses that could cause some of our most common illnesses.It's a move that could result in quicker, more effective treatment. Seven's On Call.

Having a cold or the flu is no fun. Now the FDA has cleared a new test -- the xtag respiratory viral panel -- which will help doctors diagnose their patients faster.

"The greatest need that we've had in the diagnostic field is having a test that can identify not only specific pathogens but a range of pathogens that will give us information to better manage our patients," said Dr. Donald Low.

The Xtag RVP is the first FDA-cleared test for the detection and identification of human metapneumovirus, an emerging pathogen significantly implicated in both upper and lower respiratory tract infections.

It is the first test cleared for influenza a subtypes, making it an important tool in flu surveillance nationwide.

It also is the first FDA-cleared molecular test for adenovirus, which has recently led to deaths in four major U.S. cities.

"Most clinical laboratories are missing many respiratory viruses in their diagnoses of patient samples. Most clinical laboratories detect only six or seven viruses," said James Mahony PhD.

Traditional virus testing methods require multiple tests to be performed on a patient sample and can take days to provide a diagnosis. The Xtag RVP is the first molecular diagnostic cleared by the FDA which can detect multiple respiratory pathogens from a single patient sample.

The test can also aid in the diagnosis of viral infections ranging from those causing the common cold to those implicated in serious cases of sickness and death.

Respiratory illnesses are the 7th leading cause of death in the United States so it's important that a diagnosis is made rapidly which this test will help doctors to do.


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