CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
July 2014—BioView announced that the FDA cleared for marketing its automated scanning microscope and image analysis system, the Duet, to qualitatively detect rearrangements involving the ALK gene via fluorescence in situ hybridization in formalin-fixed, paraffin-embedded non-small cell lung cancer tissue specimens, probed with the Abbott Vysis ALK Break Apart FISH Probe Kit.
The Duet is an adjunctive automated enumeration tool to be used in conjunction with manual review of the digital image and is intended for in vitro diagnostic use to detect, classify, and count cells of interest based on color, intensity, size, pattern, and shape.
BioView, 240-813-1284