This article was originally published in The Gray Sheet
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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Private placement of 1.78 mil. common stock shares at $11.25 each with selected institutional and other accredited investors raises $20 mil. The San Juan Capistrano, California firm rolled out its ACIS automated cellular imaging system in July following FDA clearance (1"The Gray Sheet" Aug. 2, In Brief). Proceeds will be used to continue the firm's transition from R&D to "active promotion and selling" of the ACIS system, the company reports. Prudential Vector Healthcare Group was placement agent for the financing
A combined final opinion on the European Chemicals Agency’s proposed microplastic restriction is expected from ECHA committees by year-end, at which point the European Commission will consider whether and when microplastic must be removed from all leave-on cosmetic products marketed in the EU.