Zacks_Analysts' Blog : FDA Nod for Quidel's hMPV Test - Analyst Blog

Leading diagnostic test solutions provider Quidel Corporation (QDEL">QDEL) has won the approval of the U.S. Food and Drug Administration (“FDA”) for its new virus test dubbed the “Quidel Molecular hMPV Assay”. The test is designed for the detection of human metapneumovirus (hMPV) infection.

The Quidel Molecular hMPV is among the several promising upcoming assays from the California-based company’s expanding molecular diagnostics programs. Quidel received European CE Mark for the test in September 2011. The FDA approval enables the company to market the Quidel Molecular hMPV assay in the U.S. ahead the forthcoming respiratory disease season.  

Identified in 2001 by investigators from the Netherlands, hMPV is the second most common cause (after respiratory syncytial virus/RSV) of upper and lower respiratory infection in young children. Studies have shown that most children are exposed to hMPV infection by the age of five. The condition which manifests itself through symptoms such as cough, runny nose, nasal congestion and fever, affects roughly 7% of children who are hospitalized with respiratory infection.

Quidel noted that the Quidel Molecular hMPV assay is its first molecular diagnostic test to be cleared for marketing in the U.S. The company’s rapidly expanding range of molecular diagnostics tests is expected to offer a number of important benefits to the end-users including increased ease of use and lower processing time.

Quidel develops and markets diagnostic solutions aimed at improving patient outcomes and offering economic benefits to the healthcare system. The company’s products are designed to detect and diagnose a host of critical diseases such as influenza, RSV, herpes and thyroid disease. Quidel competes with Alere Inc (ALR">ALR), among others.

Quidel’s sales in third-quarter fiscal 2011 soared 17% year over year led by its tests for infectious diseases. The company registered healthy growth across its Strep A (up 10% year over year) and RSV (more than doubled year over year) product lines in the quarter.