BioImagene announced that US FDA has granted the company 510(K) clearance for PATHIAM System with iScan for assessment of HER2/neu immunohistochemistry tests. The scanner and associated software are used to detect and provide a quantitative measurement of HER2/neu, a protein that is measured in breast cancer patients in order to determine if they are candidates for treatment with the breast cancer drug Herceptin. iScan is an automated digital slide scanner that provides high speed scanning of slides at 20X and 40X with superior image quality. The scanner includes features like a high-capacity autoloader for walk-away scanning of up to 160 slides and an automated slide detection system. This digital slide scanner is fully integrated with the company’s PATHIAM digital pathology workflow software to provide a powerful slide management and analysis system. PATHIAM provides users with many features including a rich menu of validated protocols, digital archiving and retrieval, flexible reporting and easy integration with LIS systems.