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Qiagen, HTG Molecular End First Project Under CDx Development Agreement

NEW YORK (GenomeWeb) – Qiagen has terminated a project with HTG Molecular Diagnostics that is part of a multi-project assay development agreement between the companies, HTG said today in a filing with the US Securities and Exchange Commission.

The project was the first of three under a master agreement for assay development, commercialization, and manufacturing, and related to a next-generation sequencing-based clinical trial assay being developed under an agreement between Qiagen and an undisclosed pharmaceutical company.

HTG noted in its filing that the termination of the project is the result of the pharmaceutical company's phase III drug trial failing to meet its endpoint, and is not attributable to any performance issues associated with HTG's products or services.

Qiagen and HTG inked the master development agreement in 2016 to offer pharmaceutical companies an NGS-based solution to develop and commercialize companion diagnostic tests with a focus on oncology. The three projects disclosed so far under the master agreement are with different undisclosed pharmaceutical partners.

HTG noted in its filing that it is not uncommon for clinical trials to fail, and as such it expects that up to half of the phase III clinical trials conducted by the pharma partners could fail to meet their endpoints. As a result, HTG expects the pipeline under the master agreement to be dynamic, including the possible initiation of new projects and termination of other projects.

HTG reconfirmed 2018 revenue guidance of $21.0 to $25.0 million that it provided in conjunction with the release of its first quarter earnings.