FDA clears Prodesse's ProParaflu+ test
This article was originally published in Clinica
Executive Summary
Prodesse's ProParaflu+ assay, which detects and differentiates parainfluenza 1, 2 and 3 viruses, has been granted 510(k) clearance from the US FDA. The real-time RT-PCR test analyses nasal swab samples to give results in around three hours. Parainfluenza viruses can cause respiratory tract infections, and although infections are not serious in most people, young children, the elderly and immunosuppressed people can experience complications such as pneumonia. Prodesse (Waukesha, Wisconsin), a wholly-owned subsidiary of Gen-Probe, said the test is "simple to use and easily integrates into a lab's existing workflow".