Epigenomics AG and Abbott Molecular Inc. Expand Strategic In Vitro Diagnostics Partnership

20-Nov-2008 - Germany

Epigenomics AG and Abbott Molecular Inc. have expand their non-exclusive strategic partnership and amended their collaboration and license agreement in molecular diagnostics closed on September 25, 2007 accordingly.

Under the amended agreement Abbott obtains additional non-exclusive commercial licenses to Epigenomics' proprietary DNA methylation technology to develop and commercialize a blood test for colorectal cancer detection based on Epigenomics' biomarker Septin 9. Further, Abbott obtains access to blood samples collected in the ongoing PRESEPT clinical study sponsored by Epigenomics. The samples are to be used in the clinical validation of an Abbott Septin 9 IVD test product for regulatory approval in the U.S. In return, Epigenomics will receive a technology license fee, certain milestone payments and reimbursements in connection with the PRESEPT study and royalties on product sales.

Both companies jointly work with good progress and according to plan on the development of a Septin 9 IVD test product for Abbott's m2000 molecular diagnostics instrument and continue anticipating the launching of a CE-marked test in Europe in late 2009 followed by regulatory filing for U.S. approval in 2010.

The Septin 9 blood test for colorectal cancer detection is Epigenomics' leading product in development. With the PRESEPT clinical study, Epigenomics intends to demonstrate that blood testing for colorectal cancer with the Septin 9 biomarker fulfils the requirements of current U.S. guidelines for colorectal cancer screening and has the potential to provide health economic benefits.

https://www.bionity.com/en/news/89965/epigenomics-ag-and-abbott-molecular-inc-expand-strategic-in-vitro-diagnostics-partnership.html