Bioanalysis Zone

US FDA extends licence with GVK BIO for its biomarker database 


GOBIOM database is composed of 20,000 biomarkers, with updated information on all biomarkers reported in clinical and preclinical studies.

GVK BIO (Hyderabad, India) recently announced that the Biomarker Qualification Group of the US FDA has extended its licence agreement with the company with reference to its comprehensive GOBIOM biomarker database. In the company press release, GVK BIO states that the database contains the latest and updated information on all the biomarkers reported in global clinical trials, clinical and preclinical studies, which will be of benefit to the FDA in its biomarker qualification process.

The database comprises biochemical, genomic, imaging, metabolite, cellular and physiological makers, which include experimental, analytical, clinical and statistical data with their qualifications listed under different medical interventions. Commenting on the announcement, Sreeni Devidas, Vice President of Sales & Marketing, and of Informatics explained, “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 interest.”

Devidas added that the company look forward to collaborating further with the FDA, with an aim to enhancing the utility of the GOBIOM database further.

Source: US FDA extends license of the GVK BIO biomarker database.



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