Epigenomics AG and Abbott Molecular Inc. Expand Strategic In Vitro Diagnostics Partnership
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.
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Topic world Diagnostics
Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.
Topic world Diagnostics
Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.