GVK extends biomarker database deal with US FDA
GVK’s database, known as GioBiom, contains information on biomarkers that are currently being examined in preclinical development or clinical trials at sites around the world.
Under the extended deal, specifics of which have not been disclosed, the US Food and Drug Administration (FDA) will use the information to further develop its guidance on biomarker qualification, a draft version of which was published last October.
GVK has worked with the FDA since 2007 when it granted the agency’s genomics group access to its database of clinical biomarkers for use in the development of its voluntary genomics data submission (VGDS) programme.
In the four years since that deal GVK’s database has grown from a list of around 300 compounds to over 12,000 biomarkers across all stages of clinical and clinical development.
