21 Jan FDA clears Prodesse respiratory virus test
Milwaukee, Wis. – A respiratory virus test manufactured by Prodesse, Inc. of Milwaukee has been cleared for marketing by the U.S. Food and Drug Administration.
The test, known as ProFlu, simultaneously detects four common respiratory viruses, including the flu, in a patient’s respiratory secretions. The company said its market differentiator is the fact that it can provides test results in as few as three hours, while other diagnostic tests for respiratory viruses are either fast but not as accurate, or are accurate but not as rapid.
The product has a platform that allows several tests to be processed using the same sample to detect influenza A virus, influenza B virus, and respiratory syncytial virus A and B (RSV). These viruses can cause influenza, an infection of the airways called bronchiolitis, and pneumonia, and all are among the leading causes of lower respiratory tract infections.
Daniel Schultz, director of FDA’s Center for Devices and Radiological Health, noted that antiviral drugs are most effective when initiated within the first two days of symptoms. He called the new test “part of the new era of molecular medicine.”
An estimated five percent to 20 percent of the U.S. population contracts influenza each year, resulting in more than 200,000 hospitalizations and up to 36,000 deaths. Influenza A, one of three types of human influenza, is the most severe and has been the cause of major epidemics. Bronchiolitis usually affects children under the age of two, and a common cause of the disease is RSV.
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• Prodesse begins clinical trials for flu virus detection
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