The National Cancer Institute (NCI) Office of Cancer Clinical Proteomics Research (OCCPR), part of the National Institutes of Health, and the U.S. Food and Drug Administration (FDA) has signed a Memorandum of Understanding (MOU) in proteogenomic regulatory science. This will allow the agencies to share information that will accelerate the development of proteogenomic technologies and biomarkers, as it relates to precision medicine in cancer.
Proteogenomics, the integration of proteomics with genomics and transcriptomics, is an emerging approach that promises to advance basic, translational and clinical research. By combining genomic and proteomic information, scientists are gaining new insights into cancer biology, that may accelerate our ability to better diagnose and treat patients, with the goal of ultimately improving patient care.
This MOU renews a commitment by the agencies to engage in scientific and programmatic collaborations in clinical proteomics and proteogenomics cancer research, such as statistical experimental design, instrument/technology validation, informatics, biological sample preparation, diagnostics, discovery, and validation of biomarkers. The MOU establishes a process by which the OCCPR, the FDA Office of In Vitro Diagnostics in the Center for Devices and Radiological Health (CDRH), and the FDA Oncology Center of Excellence (OCE) can better inform the development of proteogenomic technologies in clinical research and applications that constitute novel tools, more effective diagnostics, better characterization of novel products and molecularly-based personalized cancer therapeutics.
For more information regarding the MOU, click here.