BioImagene has announced that the company has received FDA 510(K) clearance for their 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™.
“This FDA clearance is a significant accomplishment for BioImagene and validates the innovations in our digital pathology hardware and software,” commented Dr Ajit Singh, CEO of BioImagene. “Many pathology workflow innovations are possible only by going digital. This clearance will help increase adoption of digital pathology and accelerate the progress toward personalized medicine.”
The iScan is an automated digital slide scanner that provides high speed scanning of slides at 20X and 40X with superior image quality. iScan includes features like a high-capacity autoloader for walk-away scanning of up to 160 slides and an automated slide detection system. iScan is fully integrated with BioImagene’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.