Real-Time Test for Respiratory Viruses Cleared By FDA For Marketting.

FOR IMMEDIATE RELEASE January 18, 2008

Media Inquiries: Heidi Rebello, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Clears for Marketing Real-Time Test for Respiratory Viruses
Molecular biology device detects four viruses, including influenza; results available in about 3 hours

The U.S. Food and Drug Administration has cleared for marketing a test that simultaneously detects four common respiratory viruses, including the flu, in a patient’s respiratory secretions. The ProFlu+ test provides results in as few as three hours. Other diagnostic tests for respiratory viruses are fast but not as accurate or are accurate but not as rapid.

The real-time test employs a multiplex 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. All are among the leading causes of lower respiratory tract infections.

“Antiviral drugs are most effective when initiated within the first two days of symptoms,” said Daniel Schultz, M.D., director of 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+ uses a molecular biology process to isolate and amplify viral genetic material present in secretions taken from the back of the throat in patients.

While ProFlu+ is faster than conventional tests, it is specific to the four viruses, and is more accurate when used with other diagnostics, such as patient data, bacterial, or viral cultures, and X-rays, in diagnosing a patient. Positive results do not rule out other infection or co-infection and the virus detected may not be the specific cause of the disease or patient symptoms.

An estimated 5 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. Influenza B is less severe than influenza A.

Bronchiolitis usually affects children under the age of 2, and is a common, sometimes severe illness. A common cause of the disease is RSV.

Pneumonia is a common illness that affects millions of people each year in the United States and is usually caused by an infection. People most at risk are older than 65 or younger than 2 years of age, or already have health problems.

ProFlu+ is manufactured by Prodesse, Inc. of Milwaukee.

tag: FDA, Drug Approval, influenza, ProFlu+ test, influenza A virus, influenza B virus, syncytial virus, bronchiolitis, pneumonia, Prodesse,