Quidel said late last week that it has received the CE Mark for the Quidel Molecular Influenza A+B real-time RT-PCR assay, the company's first commercial molecular diagnostic test.
The CE Mark comes just days after the company disclosed in a conference call discussing its second-quarter financial results that it had in Q2 submitted both a 510(k) package to the US and Food and Drug Administration for the assay, and an application for CE Marking to European Union regulatory authorities (PCR Insider, 8/4/11).
The assay is the first of several in Quidel's "open box" initiative, in which the company is developing molecular testing kits for infectious diseases for use on existing molecular testing platforms, such as Life Technologies' 7500 Fast Dx and Cepheid's SmartCycler.
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-US locations," Quidel said in a statement this week.
It is unclear which platform the CE Marked influenza A and B test is coupled with, although last week the company said in its conference call that the 510(k) application for the test covers its use on the 7500 Fast Dx.
The open box initiative is one prong of a three-pronged strategy recently initiated by Quidel, which has traditionally specialized in immunoassays, to establish a presence in the molecular diagnostics arena. The San Diego-based company is also working with BioHelix to develop in vitro molecular diagnostic tests for infectious pathogens in a non-instrumented, disposable platform; and is collaborating with Northwestern University to develop an integrated, low-cost molecular testing platform that will perform extraction, amplification, and detection.
"Our molecular diagnostic program is proceeding on schedule and shows great promise for the coming year," Quidel President and CEO Douglas Bryant said in a statement.