On January 9, 2018, Exosome Diagnostics, Inc. announced that it had placed an early-access version of its commercial Shahky™ System, which quantitively measures exosomal proteins, at Massachusetts General Hospital’s Center for Systems Biology in the laboratory of Dr. Hakho Lee. The Shahky System is the world’s first instrument specifically for exosomal protein analysis. Placement of this Shahky instrument, one of a number of Exosome Diagnostics early-access instruments, represents the company’s efforts within the past twelve months to develop a matured commercial system, initially created as a multiplexed nanoplasmonic research assay within the laboratory of Dr. Lee. The technology developed by Exosome Diagnostics, the Shahky System, will be used by Dr. Hyungsoon Im, an Assistant Professor of Radiology at MGH, in collaboration with Dr. Lee, to improve upon the prototype assay for the early detection of pancreatic cancer described in a May 23, 2017 Science Translational Medicine publication (http://stm.sciencemag.org/content/9/391/eaal3226) (“Multiparametric Plasma EV Profiling Facilitates Diagnosis of Pancreatic Malignancy”) by Dr. Lee, Dr. Im, and others. “In conjunction with nucleic acid detection, assessing exosomal proteins will significantly enhance diagnostic accuracy. Protein analyses can also produce actionable clinical information,” stated Dr. Lee. The commercial Shahky System has been developed and overseen by Exosome Diagnostic’s regulatory department, with design control and engineering practices that are in accordance with FDA and other applicable regulations.
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