Quidel Corporation, a leading provider of rapid diagnostic testing solutions, announced today that it has received the CE Mark for the Quidel® Molecular Influenza A+B Real-Time RT-PCR Assay -- its first molecular diagnostic test. This is the first of several forthcoming Quidel Molecular Real-Time PCR Assays that provide important benefits to the customer, including, among others, room temperature storage, reduced process time, and ready-to-use reagent configurations.
The CE mark clears the way for the launch of the open box molecular platform well in advance of the forthcoming influenza season in Europe, while also facilitating the launch of the product in other ex-U.S. locations. The product is not for sale in the U.S. at this time.
"Completing the development of our Quidel Molecular Influenza A+B Real-Time RT-PCR Assay is just the beginning of a new and very exciting time for our company," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our molecular diagnostic program is proceeding on schedule and shows great promise for the coming year."