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NCI, FDA Sign MOU on Proteogenomics Research

NEW YORK (GenomeWeb) – The National Cancer Institute and US Food and Drug Administration said today they have signed a memorandum of understanding to collaborate on proteogenomic cancer research.

According to the agencies, the MOU will allow them "to share information that will accelerate the development of proteogenomic technologies and biomarkers, as it relates to precision medicine in cancer."

Proteogenomics involves the integration of genomic and proteomic data, with the aim of leveraging multiple levels of molecular information to improve understanding of disease processes and boost biomarker discovery and development. Proteogenomic approaches are a key part of the latest stage of the NCI's Clinical Proteomic Tumor Analysis Consortium. 

According to the MOU, the process will help move proteogenomic technologies toward the clinic and to commercialization by leveraging the FDA's "analytical, product characterization, and clinical validation expertise," while improving the FDA's familiarity and experience with such technologies. This, the MOU noted, "will facilitate the review of such medical devices and therapies when they are submitted to the FDA."