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BioImagene Receives FDA 510(k) Clearance for iScan Digital Pathology Hardware
Scanner Indicated as an aid for assessment of HER2/neu in Breast Cancer Patients
Cupertino, CA, February 11, 2009
BioImagene, the leading provider of innovative digital pathology solutions, today 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, part of BioImagene’s total digital pathology solution, 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.
About BioImagene
BioImagene (www.bioimagene.com) is the leader in providing innovative and scalable digital pathology solutions for clinical diagnostics and drug discovery. BioImagene products are FDA-cleared for specific clinical applications and are intended for research use for other applications.
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