NEW YORK (GenomeWeb News) – Prodesse today said that it has received US Food and Drug Administration clearance to market its ProhMPV+ Assay for detecting human metapneumovirus just two months after filing its submission for the test.
According to the Milwaukee-based firm, the assay is the first real-time molecular diagnostic test for HMPV to receive FDA clearance. It also is the second of Prodesse’s family of respiratory virus assays to gain FDA clearance. The firm received FDA clearance for its ProFlu Assay last January.
Prodesse said that the assay is sold with all royalties fully paid, so labs running the test would not have to make any additional payments to patent holders.
“With new ASR guidelines being enforced by the FDA as of September 2008, it has become critically important for manufacturers to gain clearance for their products,” Prodesse CEO Tom Shannon said in a statement.
Prodesse is currently conducting clinical trials on its real-time assay for parainfluenza viruses, and is developing another assay for adenovirus.