By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – The US Food and Drug Administration has given 510(k) clearance to IQuum's assay for detecting and differentiating influenza A and B in about 20 minutes, the company announced today.
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.