Skip to main content
Premium Trial:

Request an Annual Quote

Qiagen, HTG Molecular Begin Third Project Under CDx Development Pact

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."

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.