CE Mark for Quidel RSV+hMPV Test

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Leading diagnostic test solutions provider Quidel Corporation (QDEL) has won the European CE Mark for its new virus test dubbed the “Quidel Molecular RSV + hMPV Assay” designed for the detection of respiratory syncytial virus (“RSV”) and human metapneumovirus (“hMPV”). RSV and hMPV are two distinct viruses that cause respiratory illness with very similar symptoms.

RSV infection, a viral disease of the lungs, is a major cause of respiratory illness (such as bronchiolitis and pneumonia) in young children. According to the U.S. Centers for Disease Control and Prevention, RSV infection is responsible for between 75,000 and 125,000 hospitalizations annually in the U.S. Virtually all infants suffer from an RSV infection before the age of two. Early detection and management are critical, given the potentially serious complications associated with RSV infection.

Identified in 2001 by investigators from the Netherlands, hMPV is the second most common cause (after 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.

The Quidel Molecular RSV + hMPV assay is among the several promising upcoming assays from the California-based company’s expanding molecular diagnostics programs. It is the company’s third molecular diagnostic test to be cleared for marketing in Europe. Quidel received CE Mark for the Influenza A+B and hMPV tests (its first and second molecular diagnostic tests, respectively) in August and September 2011, respectively.

Quidel noted that the European approval of the RSV + hMPV assay has opened the path for the launch of another molecular test for infectious disease in Europe. The test is yet to be approved for sale in the U.S.

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) among others.

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.

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