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FDA to deploy Ariana Pharma KEM biomarker technology

Ariana Pharma is set to offer its KEM (Knowledge Extraction Management) biomarker technology to FDA to facilitate data analysis for the validation of biomarker signatures.

KEM platform, a rules-based method, has been developed by Ariana Pharma to mine data and systematically extract and manage all consistent hypotheses.

The collaboration aims to help FDA systematically identify genomic ‘fingerprints’ and develop recommendations for the analysis of genomic data prior to submission of biomarker signatures through its Voluntary Exploratory Data Submission (VXDS) program.

Ariana claimed that the KEM biomarker technology can be used to identify the best subset of markers to maximize patient coverage, through the ability to evaluate heterogeneous information, including genomic, proteomic, polypharmacology, and clinical data.

FDA Center for Drug Evaluation and Research’s Office of Clinical Pharmacology operations in genomics associate director Federico Goodsaid said that they are looking forward to this collaboration to help the agency systematically analyze all equivalent signatures combining both genomic and phenotypical date, this increasing chances of selecting the best biomarker signature.

Ariana Pharma CEO Mohammad Afshar said that Ariana fully supports FDA efforts to develop more effective biomarkers for personalised medicine.