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.
Quidel recently submitted a 510(k) package to the US Food and Drug Administration for its first molecular diagnostic assay, a real-time PCR-based test for influenza A and B for use on Life Technologies' 7500 Fast Dx platform.
Enigma coordinated a consortium called Ranger that began in July 2008 under a €3 million grant from the Seventh Framework Programme to develop a rapid, fully automated molecular diagnostic system and test for seasonal influenza strains.
The company disclosed two additions to its board of directors, including former Roche Molecular Systems CEO Heiner Dreismann, as it moves to commercialize its AIR biomarker detection platform for clinical research and diagnostic applications.
The test runs on Cepheid's GeneXpert system and simultaneously detects and differentiates Influenza A, Influenza B, and the 2009 H1N1 influenza virus in about one hour.
Enigma's testing platform combines fully automated sample extraction with real-time PCR amplification and detection and is designed to achieve results in less than one hour.
Nanosphere said that the RV+ test detects influenza A and B and respiratory syncytial virus A and B, and further subtypes flu A as H1, H3, or 2009 H1N1.
