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HTG, Merck KGaA Ink CDx Development Deal for Lymphoma Drug

NEW YORK (GenomeWeb) – HTG Molecular Diagnostics announced yesterday that it has signed a master companion diagnostics development agreement with Merck KGaA, which will initially focus on a test for use with the German drugmaker's investigational Bruton's tyrosine kinase (BTK) inhibitor M7583.

BTK is an enzyme associated with B cell development and implicated in certain autoimmune diseases and cancers. Merck is developing M7583 as a treatment for B cell lymphoma and expects to begin clinical testing of the drug this year.

Under the terms of their deal, the companies will develop a companion diagnostic for M7583 based on HTG's EdgeSeq Diffuse Large B-Cell Lymphoma (DLBCL) Cell of Origin Assay, which uses next-generation sequencing-based gene expression profiling to determine the cell of origin subtype of DLBCL tumors. The assay received CE IVD marking earlier this year. Additional development programs may follow, according to TJ Johnson, HTG’s President and CEO.

Further terms of the agreement were not disclosed.