Quidel Corporation, a leading provider of rapid diagnostic testing solutions and cell-based virology assays, announced today that it has received the CE Mark for the Quidel Molecular(TM) RSV + hMPV assay for the detection of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).
The CE Mark for Quidel's molecular RSV + hMPV assay clears the way for the launch of another infectious disease molecular test offering in Europe. The assay distinguishes between RSV and hMPV, two different viruses that cause respiratory infections with very similar symptoms.
Quidel Molecular RSV + hMPV is one of several forthcoming assays from Quidel's expanding line of molecular diagnostics products. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing thermocyclers. These reagents provide attractive features that include simple transport and refrigerated storage (no freezer required), convenient workflow, a short time to result, and other benefits that favorably affect diagnostic test outcome. Because they share a common extraction protocol, the RSV + hMPV assay can be batched alongside the Quidel Molecular Influenza A+B PCR assay in the same multi-well panel for customized multiplexing capability.
"We are very proud to receive CE Mark for RSV + hMPV, our newest Quidel Molecular product offering," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We are pleased with our ability to provide healthcare workers in Europe with a diversified set of molecular testing options while also making efficient use of their existing test infrastructure."
This assay is Quidel's third molecular product offering to receive authorization to market in Europe. Quidel Molecular assays for Influenza A+B and hMPV received CE Mark in August and September of last year, respectively. Quidel Molecular RSV + hMPV is not for sale in the U.S. at this time.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the QuickVue(R), D3(R) Direct Detection and Thyretain(R) leading brand names, as well as under the new Sofia(TM) and Quidel Molecular(TM) brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, mononucleosis, thyroid disease and fecal occult blood. Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories.