Clinical Proteomic Technologies for Cancer: NIH-Funded Measurement Science.

In 2006, the National Cancer Institute (NCI) launched the Clinical Proteomic Technologies for Cancer initiative (CPTC). The overall mission of this initiative was to foster the building of an integrated foundation of proteomic technologies, data, analysis systems, and reagents and reference materials to systematically advance the application of protein science to accelerate discovery and clinical research in cancer. Specifically, the CPTC was charged to address issues of variability and irreproducibility in proteomic measurements. During the past five years, CPTC investigators have focused on assessing proteomic platforms involving mass spectrometry. Inter-laboratory studies have addressed variability in both unbiased and targeted mass spectrometric methods. These studies have produced reference materials and data, performance metrics, standard operating procedures, and guidance for the community on the current ability of mass spectrometry for proteomics. Outputs from the technology assessment aspects of CPTC have leveraged additional developments. First, CPTC inter-laboratory studies provided a basis for engaging the FDA on the metrological requirements for approval in vitro diagnosticmultivariate index assays. Second, the NCI developed a follow-on funding opportunity that applies the technology pipeline developed in the first phase of CPTC.