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GVK Biosciences today announced that it is extending its Clinical Biomarker Database (GOBIOM) licence to the Biomarker Qualification Group of the US Food and Drug Administration.
The biomarker database, which has the latest and recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial to the USFDA in its qualification process.
GOBIOM database
The GOBIOM database is a compilation of all the clinically evaluated, exploratory and preclinical biomarkers associated with different therapeutic areas reported in global clinical trials, clinical and preclinical studies.
It contains information on 20,000 biomarkers comprising biochemical, genomic, imaging, metabolite, cellular and physiological markers. It includes multiple data points comprising experimental, analytical, clinical and statistical data with their qualifications under different medical interventions.
Sreeni Devidas, Vice-President, Sales and Marketing, Informatics, in a statement said: “The collaboration with the USFDA has helped GVK Bio in developing the safety biomarker content. 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 to facilitate the user to make a comparative analysis between the biomarkers of their interest, he further said.
The Hyderabad-based GVK Bio works on discovery, research and with development organisations providing a broad spectrum of services.
rishikumar.vundi@thehindu.co.in
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