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WaveSense, Inc. Receives CE-IVD Marking Approval for Its Cell Enrichment Technology Platform

WaveSense, Inc. the leader in targeted cell isolation and enrichment from liquid biopsies, announced today that it has received CE-IVD marking approval for their suite of cell isolation and enrichment technologies. The approval includes the EpiSepĀ® direct to slide enrichment technology as well as their proprietary paramagnetic bead technology for the selective isolation of cells expressing CD138. CE marking allows for marketing and sales of the products in the European Union and other countries. The WaveSense system, a growing pipeline of cell enrichment products, can be used for selective recovery/enrichment of cells expressing the CD138 cell surface antigen in biological fluids and tissue culture "CE marking approval for the WaveSense product line, a FDA Class I technology, represents a significant milestone and accomplishment by all of the employees of WaveSense," said CEO William Curtis, "The completion of the registration signifies that we are complying with the high standards of the EU governing authorities in the areas of quality, safety and performance."