Quidel said this week that it has received the CE mark for its AmpliVue C. difficile assay, making it the first commercially available test using Quidel's non-instrumented format.

The assay, which is now for sale in European countries recognizing the CE Mark, detects toxigenic Clostridium difficile bacterial DNA. It incorporates lateral flow technology licensed from Alere and isothermal helicase-dependent amplification technology licensed from BioHelix in a compact, handheld cassette.

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