HTG and Merck KGaA enter CDx agreement
TUCSON, Ariz. & DARMSTADT, Germany—HTG Molecular Diagnostics Inc., a provider of instruments and reagents for molecular profiling applications, and pharma company Merck KGaA of Darmstadt, Germany, have entered a broad companion diagnostics master agreement related to diffuse large B cell lymphoma (DLBCL). The initial development program agreement utilizes the HTG EdgeSeq DLBCL Cell of Origin Assay in the Merck KGaA program focused on M7583 and the selective and irreversible inhibitor of Bruton’s tyrosine kinase (BTK).
“We are honored to be chosen as the diagnostic development partner for Merck KGaA’s BTK program and our team is now focused on the near-term milestones. Additionally, having a master companion diagnostic agreement paves the way for additional development collaborations,” stated TJ Johnson, HTG’s president and CEO. “We have worked very hard to establish the organizational capabilities to support the development, regulatory filing and commercialization of companion diagnostics demonstrated by the recent CE/IVD marking of HTG’s DLBCL cell of origin assay.”
Headquartered in Arizona, HTG’s mission is to “empower precision medicine at the local level.” In 2013, the company commercialized its HTG Edge instrument platform and a portfolio of RNA assays that leverage HTG’s proprietary nuclease protection chemistry. HTG’s product offerings have since expanded to include its HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing.