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FDA Extends License for GVK Biosciences' Clinical Biomarker Database


GVK Biosciences said this week that the US Food and Drug Administration has extended its license for the Hyderabad, India-based firm's clinical biomarker database.

The company said that the FDA's biomarker qualification group will use the resource, named GOBIOM, short for GVK BIO Online Biomarker Database.

GVK launched GOBIOM in 2008. It currently contains information on 12,000 biomarkers comprised of biochemical, genomic, imaging, metabolite, cellular, and physiological markers. Each marker includes multiple data points that cover experimental, analytical, clinical, and statistical data with their qualifications under different medical interventions.

As part of the development process for GOBIOM, GVK worked with the FDA’s genomics group to develop the data model that underlies the database. In addition, the FDA signed an agreement with GVK in 2007 to use information from the database as part of its Voluntary Genomics Data Submission program (BI 03/28/2008).

Sreeni Devidas, vice president of informatics sales and marketing for GVK, said in a statement that the firm's past collaboration with the FDA led to the development of safety biomarker content in GOBIOM.

"The interconnectivity between the organ toxicities to the drug, dose, and population was developed with equal emphasis on its preclinical qualification," he said. "Biomarker analysis tools were integrated into the database such that the user can make comparative analysis between the biomarkers of their interest.”