05 Jan Prodesse's flu test receives FDA clearance
Milwaukee, Wis. – Prodesse, Inc., a biotechnology company that is developing products to detect infectious disease, has announced clearance from the Food and Drug Administration to market its ProFlu+ diagnostic assay.
The clearance came two months after submission of ProFlu+, a molecular diagnostic assay that simultaneously detects and differentiates influenza A virus, influenza B virus, and the respiratory syncytial virus (RSV) from a single specimen.
Prodesse believes the ProFlu+ assay, which uses real-time PCR (polymerase chain reaction) technology, is simpler to use, easier to integrate into existing lab workflow, and will generate market differentiation. Not only is it the first real-time molecular diagnostic test for respiratory viruses to receive FDA clearance, but it also is the first cleared infectious disease test to detect as many as three organisms simultaneously.
“We are convinced that we made the right choice choosing real-time PCR as our core technology platform,” Tom Shannon, CEO of Prodesse, said in a press release. “Laboratorians are telling us that the `big box’ multiplex systems are cumbersome and more appropriate for epidemiological, not clinical applications.”
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