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This article was originally published in The Gray Sheet

Executive Summary

Rolls out its ACIS automated cellular imaging system following FDA clearance for use with any immunohistochemistry (IHC) staining test that has undergone company validation, ChromaVision announces July 29. The system will be capable of processing IHC slides for micrometastases detection immediately, ChromaVision notes. Analysis of HER-2/neu tests will be added in the next 30 days, followed by cytomegalovirus, estrogen and progesterone tests in the fourth quarter. ChromaVision plans to offer the instrument at no cost and charge institutions for each test result, with prices ranging from roughly $30 for infectious disease tests to $150 for some complex cancer tests. In clinical studies, pathologists reversed 44% of initially negative diagnoses when using the instrument, which provides a 300% increase in sensitivity over manual methods, ChromaVision claims

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