GVK Biosciences is extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the U.S. FDA. The GOBIOM database has the latest and recently updated information on all biomarkers reported in various clinical and preclinical studies and will be used by the FDA in its biomarker qualification process.
GOBIOM contains information on 20,000 biomarkers comprising biochemical, genomic, imaging, metabolite, cellular and physiological markers, as well as multiple data points on experimental, analytical, clinical and statistical data with qualifications under different medical interventions.
Sreeni Devidas, vice president of sales and marketing at Informatics, said, “The collaboration with the FDA has helped GVK BIO in developing the safety biomarker content in GOBIOM. 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. We look forward to continue working and collaborating with the FDA with a view to enhancing the utility of the product further.”