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HTG Molecular Diagnostics, Qiagen Ink CDx Commercialization, Distribution Agreement

NEW YORK – HTG Molecular Diagnostics and Qiagen subsidiary Qiagen Manchester said on Monday that they have signed a 10-year commercialization and distribution agreement, with the goal to offer pharmaceutical companies global development, distribution and commercialization capabilities for companion diagnostic (CDx) assays based on HTG's EdgeSeq platform.

The agreement allows HTG to work directly with biopharma customers for CDx development programs including assay development, clinical trial oversight, and global regulatory submissions, with potential CDx assays developed integrating either an Illumina or Thermo Fisher Scientific next-generation sequencing instrument. When a CDx is required, HTG customers will have global distribution and commercialization options with Qiagen.

"Our biopharma customers want the ability to develop new biomarkers with our HTG EdgeSeq technology, along with the ability to distribute them globally," Byron Lawson, senior VP and chief commercial officer of HTG, said in a statement. "We can now provide our customers with the confidence that they will be able to use our HTG EdgeSeq technology and capabilities, while leveraging the proven commercial expertise and distribution scale of Qiagen." 

Financial details of the agreement were undisclosed.

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