• BioImagene (Cupertino, California) has received FDA clearance for its 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. The iScan is an automated digital slide scanner that provides scanning of slides at 20X and 40X with good image quality. iScan features an 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 features including a rich menu of validated protocols, digital archiving and retrieval, flexible reporting and easy integration with LIS systems.

• Osiris Therapeutics (Columbia, Maryland) reported the final two-year results for the company's trial evaluating Prochymal for the treatment of acute myocardial infarction. Prochymal is a formulation of adult stem cells designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation. This study, which evaluated safety and preliminary efficacy, found that heart attack patients receiving the intravenous therapy had lower rates of adverse events and significantly improved heart function. Prochymal is a preparation of mesenchymal stem cells specially formulated for intravenous infusion. The stem cells are obtained from the bone marrow of healthy adult donors. Prochymal is currently being evaluated in Phase III trials for steroid refractory GvHD, acute GvHD, and Crohn's disease.