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MolecularHealth, FDA to Evaluate Drug Safety Assessment Software

NEW YORK (GenomeWeb News) – MolecularHealth today said that it has signed a five-year deal with the US Food and Drug Administration to evaluate and refine the firm's software system for mechanism-based drug safety assessment and prediction.

Last month the firm launched the system, Molecular Analysis of Side Effects, or MASE, as a software-as-a-service offering for use in drug safety assessment and prediction. It combines information from the US Food and Drug Administration's Adverse Event Reporting System with clinical and molecular information about drug activity in patients to help users analyze a drug's safety profile from both molecular and statistical perspectives.

MolecularHealth, which recently changed its name from Life Biosystems, said FDA's Center for Drug Evaluation and Research will help the firm incorporate non-proprietary molecular and clinical endpoints of regulatory interest to MASE, as well as non-proprietary information on patient populations, drug promiscuity, molecular modes of action, and mechanisms of disease.

"We believe that MolecularHealth's predictive approach to understanding the molecular basis of adverse events will complement the agency's current mode of drug safety assessment to advance the promise of precision medicine," David Jackson, chief scientific officer of Molecular Health, said in a statement.

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