NEW YORK (GenomeWeb News) – Prodesse has filed with the US Food and Drug Administration for 510(k) clearance of its real-time PCR-based Pro hMPV+ Assay for rapid detection of human metapneumovirus.
Prodesse said that the assay can provide accurate results in as little as three hours compared to days or weeks for non-molecular methods. hMPV was discovered in 2001 and causes acute respiratory illness. Its prevalence ranges from 6.6 percent to 12 percent annually of patients with symptoms of respiratory infection.
The Milwaukee, Wis.-based firm did not say when it expects to receive clearance for the assay.
In January, Prodesse received FDA clearance for its ProFlu+ Assay. It currently is developing additional tests for differentiating parainfluenza 1, 2, and 3 viruses and adenovirus.