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HTG Molecular Diagnostics Gets CE IVD Mark for NGS System, Cell-of-Origin Assay

NEW YORK (GenomeWeb) – HTG Molecular Diagnostics announced today that it has received CE IVD marking for its next-generation sequencing-based HTG EdgeSeq system and its HTG EdgeSeq Diffuse Large B-Cell Lymphoma Cell of Origin Assay.

The assay, which was released in October 2015, uses gene expression profiling to determine the cell of origin subtype of DLBCL tumors from formalin-fixed paraffin-embedded tissue samples, the company said. The assay's classification algorithm can determine whether a tumor is activated B-cell like, germinal B-cell like, or unclassified.

"This assay was developed in anticipation of the 2016 updates to the [World Health Organization] guidelines for DLBCL," Chris Roberts, HTG's senior vice president of corporate strategy and marketing, said in a statement. "Unlike traditional immunohistochemistry approaches requiring multiple tumor sections and multiple assays to sub-classify DLBCL, our HTG EdgeSeq DLBCL Cell of Origin Assay provides such classification from only a single FFPE tissue section."

In March, the company announced it had signed a deal with Thermo Fisher Scientific to develop several in vitro diagnostic tests for use with Thermo Fisher's Ion PGM Dx NGS system, combining it with the EdgeSeq chemistry and automation platform. It struck a similar deal with Illumina in October 2014 to develop IVD diagnostic kits using Illumina's sequencing technology and the Edge platform.