FDA OK’s Real-Time Test for Respiratory Viruses

ProFlu+ test from Milwaukee based Prodesse, Inc. is a multiplex real-time PCR assay to simultaneously detect and differentiate influenza A , influenza B and respiratory syncytial virus (RSV). The test has just been approved for marketing by the FDA, and was CE Mark’ed by the European Union in the past. The company touts that it is “the first real-time molecular diagnostic test for respiratory viruses to receive FDA clearance … also it is the first cleared real time molecular infectious disease test to detect as many as three organisms simultaneously.”
Here’s what the FDA says:

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.

FDA Clears for Marketing Real-Time Test for Respiratory Viruses …
Press release: Prodesse’s Multiplex RT-PCR ProFlu+™ Assay Receives FDA Clearance …
Product brochure (.pdf)…