GVK Bio Licenses Biomarker Database to FDA

GVK Biosciences has extended its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the FDA. The GOBIOM database is a comprehensive collection of clinically evaluated, exploratory and preclinical biomarkers associated with different therapeutic areas reported in global clinical trials. It contains information on 12,000 biomarkers comprising biochemical, genomic, imaging, metabolite, cellular and physiological markers.

Sreeni Devidas, vice president, sales and marketing of Informatics, said, “The collaboration with the FDA helped GVK BIO in developing the 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. Biomarker analysis tools were integrated into the database such that the user can make comparative analysis between the biomarkers of their interest.”