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GVK Renews License for Biomarker Database to FDA

NEW YORK (GenomeWeb News) – Indian contract research organization GVK Bio announced today the extension of its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the US Food and Drug Administration.

The GOBIOM database contains the most recent information on all biomarkers reported in various clinical and preclinical studies. In total, it has data on more than 20,000 biomarkers, including biochemical, genomic, imaging, metabolite, cellular, and physiological markers. Also included are multiple data points "comprising experimental, analytical, clinical, and statistical data with their qualifications under different medical interventions," GVK said.

"The collaboration with the US FDA has helped GVK BIO in developing the safety biomarker content in GOBIOM," Sreeni Devidas, vice president of sales and marketing for informatics at GVK, said in a statement. "The interconnectivity between organ toxicities to the drug, dose and population was developed with equal emphasis on its preclinical qualification. Biomarker analysis tools were integrated into the database in a manner that has facilitated the user to make a comparative analysis between the biomarkers of their interest."

The FDA group originally licensed the GOBIOM database in 2007 and renewed it in April 2011.