FDA and NCI Memorandum Indicates Growing Interest in Proteogenomics as Clinical Approach

NEW YORK (GenomeWeb) – Proteogenomics remains an emerging science, but a memorandum of understanding announced this week by the National Cancer Institute and the US Food and Drug Administration indicates growing interest in the approach as a tool for research and precision medicine.

The MOU calls for the two agencies “to share information that will accelerate the development of proteogenomic technologies and biomarkers, as it relates to precision medicine in cancer,” and reflects FDA’s view of proteogenomics as a likely significant clinical technology in coming years.

“Looking ahead and kind of skating to where the puck will be, we think that more and more sponsors will be embedding proteogenomics [in their submissions],” said Gideon Blumenthal, deputy director, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research at FDA. “It’s more exploratory now, but probably in the next five to 10 years it will be potentially used for more clinical decision making. So we feel we need to get ahead of the science and learn about the state of the science with experts and other sister agencies like NCI.”

Driven by technologies like next-generation sequencing and improvements in the breadth and quality of proteomic data, proteogenomics has seen

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