Waltham, Mass., January 9th, 2018 – Exosome Diagnostics, Inc. has 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 fleet of Early Access instruments, represents Exosome Diagnostics’ efforts within the past 12 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 2017 Science Translational Medicine publication. “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 Dx’s Regulatory Department, with design control and engineering practices that are in accordance with FDA and other applicable regulations. “We are excited placing an early access instrument at MGH for exosome protein detection and this represents a key milestone that legitimizes our development efforts and keeps us on track for our 2018 commercialization strategy,” said Mario Morken, Head of Business Development at Exosome Diagnostics.
ExosomeDx has commercialized the world’s first exosome test based on RNA but is now moving into the field of exosomal proteins. “Protein biomarker analysis from complex biofluids such as plasma is challenging, but looking at the exosome compartment instead of total protein enables you to see signatures not present in total plasma,” said Johan Skog, Chief Scientific Officer at Exosome Diagnostics.
“Exosome Diagnostics has significantly expanded the breadth of its diagnostic and companion diagnostics platform via a point of care system that will enable clinicians and researchers to obtain results from liquid biopsies within minutes,” stated John Boyce, President and CEO of Exosome Diagnostics. “Working closely with the appropriate regulatory agencies, and with key partners such as Mass General Hospital, Exosome Diagnostics will develop liquid biopsy based, point of care oncology assays,” Boyce continued. “These tests will provide significantly earlier diagnosis in cancers that are often diagnosed at later stages, such as ovarian and pancreatic cancer,” Boyce concluded.