FDA approves new respiratory virus test

January 21, 2008

The U.S. Food and Drug Administration has approved a test that detects four respiratory viruses, including the flu, in a patient's respiratory secretions.

The ProFlu+ test provides results in as few as three hours. The FDA said other diagnostic tests for respiratory viruses are fast but not as accurate, or are as accurate but odn't givce results as quickly.

The real-time test employs a multiplex platform that allows several tests to be processed simultaneously using the same sample to detect influenza A virus, influenza B virus and respiratory syncytial virus A and B. Those viruses, said the FDA, can cause influenza, an infection of the airways called bronchiolitis, and pneumonia.

"Antiviral drugs are most effective when initiated within the first two days of symptoms," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "This new test, which is part of the new era of molecular medicine, can help the medical community quickly determine whether a respiratory illness is caused by one of these four viruses and initiate the appropriate treatment."

ProFlu+ is manufactured by Prodesse Inc. of Milwaukee.

Copyright 2008 by United Press International

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