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WaveSense Receives CE-IVD Mark for Cell Enrichment Platform

NEW YORK (GenomeWeb) – WaveSense, a company developing a platform for rare cell isolation and enrichment, said today that it has received CE-IVD marking for its technologies.

The approval includes the company's EpiSep direct-to-slide cell enrichment technology, as well as its proprietary paramagnetic bead technology, which allows for selective isolation of cells that express CD138.

According to the company, its technologies need only a small specimen in order to isolate target cells while eliminating background cells, and don't require expensive equipment. Once cells are isolated, they can be funneled for downstream diagnostic analyses including IHC, FISH, PCR, measurement of gene expression, or next-generation sequencing.

In a statement, WaveSense said that the technology is already in "routine clinical use for multiple liquid biopsy applications," including the capture of CD138-positive cells. University of Texas MD Anderson Cancer Center researcher Gary Lu, for instance, has conducted research using the platform to capture CD138-positive plasma cells from bone marrow specimens in order to increase the sensitivity of FISH for detecting high-risk cytogenomic abnormalities.

"The CD138 isolation and enrichment product for bone marrow is the company’s immediate commercialization focus in the EU," WaveSense CEO William Curtis added.