FDA Clears New CDC Test to Detect Human Influenza

The U.S. Food and Drug Administration (FDA) today cleared a new test
developed by the U.S. Centers for Disease Control and Prevention (CDC)
to diagnose human influenza infections and the highly pathogenic
influenza A (H5N1) viruses.

The device, called the Human Influenza Virus Real-Time RT-PCR Detection
and Characterization Panel (rRT-PCR Flu Panel), uses a molecular biology
technique to detect flu virus and differentiate between seasonal and
novel influenza.

The device is used to isolate and amplify viral genetic material present
in secretions taken from a patient's nose or throat. The viral genetic
material is labeled with fluorescent molecules, which are then detected
and analyzed by a diagnostic instrument called the Applied Biosystems
7500 Fast Dx, also cleared today by the FDA for diagnostic use
simultaneously with the CDC's rRT-PCR Flu Panel.

The test panel and diagnostic system can detect and identify commonly
circulating human influenza viruses as well as influenza A (H5N1)
viruses. Results can be available within four hours and the system can
test multiple samples at once.

"This is a significant achievement for public health surveillance," HHS
Secretary Mike Leavitt said. "The test allows us to better support
laboratories on the front line of influenza testing in the United States
and abroad."

"The application of the test to detect an emergent influenza virus would
be especially important in the early stages of a pandemic," Secretary
Leavitt added. "This breakthrough allows for a more timely detection of
a pandemic virus, which helps in determining when to begin broad control
strategies as well as life-saving mitigation measures, such as closing
schools, cancelling social gatherings and informing businesses to begin
work-at-home policies."

The test will be available to CDC-qualified laboratories for diagnosing
influenza this fall, and some laboratories will be able to obtain
reagents (certain substances used in the testing process) at no cost.
This test should help ensure the accuracy of influenza testing results
among the different qualified laboratories that conduct influenza
subtype testing.

"This new test provides us another tool in our toolbox to fight seasonal
influenza, a virus that unfortunately kills thousands of people each
year in the United States," said CDC Director Dr. Julie Gerberding.
"We'll now be able to detect influenza in the community faster, which
allows us to take steps more quickly to protect and save lives."

Since influenza viruses are always changing, test reagents need to be
evaluated regularly against circulating viruses to ensure the
sensitivity and specificity of the test to diagnose current influenza
viruses.

"Because the test can tell the difference between seasonal human
influenza viruses and novel viruses, it will also provide qualified
laboratories with a means to rapidly detect new influenza viruses that
have not been identified yet and that could pose a pandemic risk," said
FDA Principal Deputy Commissioner and Chief Scientist Dr. Frank Torti,
M.D., M.P.H.

The CDC, Applied Biosystems of Foster City, Calif., and the Association
of Public Health Laboratories collaborated on the development of this
new test. State public health laboratories in Virginia, Iowa,
California, Massachusetts, Wisconsin, and Washington performed clinical
evaluations of the new flu panel.

Scientists around the world are concerned that the H5N1 virus could one
day mutate and acquire the properties needed to quickly spread between
people, resulting in a pandemic. H5N1 viruses circulate widely in birds
in Asia, Africa and Europe and have caused human illness and death.
These viruses have never been detected in the Americas.

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