The NCI's Clinical Proteomic Technology for Cancer Initiative (CPTC) has been actively overcoming the technological barriers to advance the science of proteomics. As we begin to transition into the next Phase of the program that seeks to leverage the achievements from the initial phase with a focus on characterizing the protein content of genomically characterized tumors [e.g. The Cancer Genome Atlas (TCGA), a partnership between the National Cancer Institute (NCI) and National Human Genome Research Institute (NHGRI)] in order to better understand cancer biology and provide this data with accompanying assays and protocols to the public; we first wanted to highlight some of the other work that has developed through the initiative and in the field of proteomics in general. At the start of CPTC (Fall 2006), several roadblocks were listed as impediments to advancing the field including lack of understanding of Food and Drug Administration (FDA) regulatory process, minimal technology development/standardization, and a dearth of publicly-accessible well-characterized affinity reagents. In this issue of eProtein, we present some of the latest advances propelled by the Initiative and outside investigators to address these roadblocks and helping to transition cancer proteomic discoveries into biological insights.
Working in collaboration with CPTC investigators along with collaborators from the FDA, Scientist from the National Heart, Lung, and Blood Institute, the Center for Medicare & Medicaid Services, and clinical chemist from the American Association for Clinical Chemistry, we have recently published a paper that address key issues in approval process of protein-based diagnostic technologies for FDA approval. The article entitled Journey to Regulation of Protein-Based Multiplex Quantitative Assays provides design insight for researchers and perspective for those interested in moving their assay from the lab to being approved by the FDA.
In addition to advancing the field of regulatory science, CPTC has also been active in meeting the need for highly characterized renewable affinity reagents. Now, NCI's Antibody Characterization Program is open to the entire research community. From now until July 1, 2011 researchers can submit cancer related protein targets that if selected monoclonal antibodies will be produced and characterized for public distribution. More information about this program and other developments within the Antibody Characterization Program are highlighted in this issue.
Lastly, we want to share with you some of the work out of the lab of Dr. Mike MacCoss as he and developer Brendan MacLean have continued to develop Skyline, an open-source software utilized by several proteomic research groups. During the last year, Skyline reached a licensing agreement with mass spectrometer vendors that will aid users in sharing data and methodologies. This agreement was made through the parent project of Skyline, ProteoWizard, and now all non-commercial software can access these data points from several mass spectrometer vendors to allow for enhanced collaborative sharing.
We invite you to read eProtein and feel free to contact us with your latest news in cancer proteomics.