Quidel Receives CE Mark for its Molecular Diagnostic Test for Human Metapneumovirus
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Quidel Corporation, has announced that it has received the CE Mark for the Quidel® Molecular hMPV Real-Time RT-PCR Assay.
This assay is Quidel's second molecular diagnostic test to receive authorization to market in Europe. This announcement follows the notice of the European launch of Quidel's first molecular diagnostic test - its RT-PCR test for Influenza A+B on August 5th.
Quidel's rapidly expanding menu of molecular diagnostic RT-PCR tests will provide several important benefits to the customer, including enhanced ease of use, reduced processing time, and ready-to-use reagent configurations.
The CE Mark for Quidel's molecular hMPV assay clears the way for the launch of another infectious disease molecular test offering in Europe well in advance of the respiratory disease season. This product is not for sale in the U.S. at this time.
"With the completion of each assay development project, we become even more confident in our ability to execute our pipeline strategy," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "The CE Mark for hMPV is another milestone met, and evidence that we are on track with our molecular diagnostic strategy."
Human metapneumovirus, recently discovered in 2001, infects most children by the time they reach five years of age. It can cause serious respiratory infections, especially in infants, young children, the elderly, and in patients of all ages that are immunocompromised.
This disease accounts for about 7% of children admitted to the hospital with respiratory infection. Symptoms of hMPV are very similar to and sometimes indistinguishable from those caused by human respiratory syncytial virus (RSV).