Firm is looking to develop a blood-based assay for use on its QIAsymphony platform.
Qiagen has negotiated a two-year option to secure a worldwide nonexclusive commercial license to Epigenomics’ mSEPT9 blood biomarker for colorectal cancer and related DNA methylation analysis technologies. Epigenomics has in addition granted Qiagen a research license to the IP, under which the latter is developing a sample preparation technology designed to be suitable for broad use with methylaton-based molecular diagnostics tests on its QIAsymphony molecular testing platform.
To help speed the research phase along, Epigenomics will provide relevant know-how and clinical specimens, for which Qiagen will reimburse the firm. Epigenomics will also receive an up-front fee, a license fee if Qiagen exercises its commercial license option, and royalties and commercial milestones on the future sales by Qiagen of resulting products.
Epigenomics says the deal is in line with its dual business strategy for the colorectal cancer blood test. The firm is directly commercializing the test under its own Epi proColon brand, and is separately granting nonexclusive licenses to the mSEPT9 biomarker and DNA methylation technologies to the diagnostics industry.
“This agreement adds to our content pipeline and further broadens the menu of assays optmized for superior performance on our novel modular QIAsymphony and QIAensemble platforms,” notes Ulrich Schriek, vp for global business development at Qiagen.
The Epi proColon test has been available as a CE-marked test kit in Europe since October 2009. In January Epigenomics announced that it had concluded the feasibility phase of development for an improved Epi proColon concept, which is being developed for the U.S. market, and as a second-generation product for European and other markets.
The new assay is designed to measure the same epigenetic information in the Septin9 gene, but design changes have been implemented based on data from more recent studies performed by Epigenomics and its partners as well as feedback from current customers in Europe and market surveys in the U.S.
As a result, the firm says the new platform has an improved capacity for automation, will use reagents manufactured under the cGMP standard, and will employ a real-time PCR platform that has previously been cleared by the FDA for use with diagnostic assays. Epigenomics claims performing the updated assay will consequently require fewer components and handling steps and will generate results within a normal eight-hour laboratory working day. The firm was due to hold a pre-IDE meeting with FDA during February to discuss the product concept, its intended use, and the clinical data required to support a marketing application in the U.S.