NEW YORK (GenomeWeb) – HTG Molecular Diagnostics said today that it has entered into a third project for a new clinical assay development program under an existing master assay development, commercialization, and manufacturing agreement with Qiagen.
The new project relates to development activities for a next-generation sequencing-based clinical trial assay associated with a sponsored project agreement between Qiagen and an undisclosed pharmaceutical company, according to a document filed by HTG with the US Securities and Exchange Commission.
This is one of three development programs, each for a different pharmaceutical company, announced to date under the master agreement between Qiagen and HTG. If successfully completed, the projects are expected to lead to subsequent assay development activities and potential commercialization of companion diagnostic assays for corresponding drugs from the pharma partners.
For the newest project, which is expected to be completed in the second quarter of 2018, Qiagen has agreed to pay HTG low single-digit millions of dollars in development fees, according to the SEC filing. In addition, HTG and Qiagen will share any net profits generated by the project on an approximately quarterly basis.
"We are very excited to initiate a third assay development program for yet another pharmaceutical company under our Qiagen master agreement, which we believe further demonstrates the strength of our combined value proposition in the development of companion diagnostics," HTG President and CEO TJ Johnson said in a statement. "This new program has a very aggressive development timeline, including the possibility of a first regulatory filing in 2018."