GVK extends biomarker database deal with US FDA

- Last updated on GMT

Related tags: Contract research organization, Food and drug administration

Indian contract research organisation (CRO) GVK Biosciences has granted the US FDA continued access to its biomarker database in an extension of the organisations’ existing agreement.

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.

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