CPTAC continues to define the most rigorous standards for proteomic experiments.
A key contribution of CPTAC is the collaborative nature of the consortia, and the open communication among the participating components.
Specifically, the CPTAC program is designed to develop multidisciplinary approaches to the evaluation and implementation of high-throughput mass spectrometry [MS] and affinity-based proteomics platforms pertinent to clinical cancer research.
As specified in a pre-application meeting document, each CPTAC team will develop a proteomic analysis platform, and the teams will share materials, protocols, data, samples, algorithms and resources.
The CPTAC request for applications (RFA) cited specific MS platforms, specifically, time-of-flight (TOF) MS, Fourier transform ion cyclotron resonance (FTICR) MS, tandem MS/MS and liquid chromatography (LC)-MS, as well as MALDI matrix-assisted laser desorption-ionization (MALDI) and electrospray-ionization (ESI) ionization sources.
Something worth considering within the CPTAC community would be to take one MS assay through a set of performance studies equivalent to those required for a 510(k)--e.
15] Nonstandard abbreviations: FDA, US Food and Drug Administration; MS, mass spectrometry; CPTAC, Clinical Proteomic Technology Assessment for Cancer; IDE, investigational device exemption.
In addition to the white paper (workshop summary), the workshop also recommended that CPTAC take the lead in developing "mock 510(k)" documents (nonregulatory documents in the form of 510(k) submissions) provided to the FDA that would help orient the FDA to multiplex mass spectrometry and affinity array platforms in novel diagnostics and serve as a springboard for guidance to the proteomics community.
Because there is currently no guidance for multiplexed protein assays (such as multiplex mass spectrometry or multiplex immunoaffinity assays), the workshop provided an opportunity to involve CPTAC scientists, the FDA, and others in the proteomics community to begin to work through the issues that might be raised in regulatory review of such tests.
2] Nonstandard abbreviations: CPTAC, Clinical Proteomic Technology Assessment for Cancer; NCI, National Cancer Institute; FDA, US Food and Drug Administration; CPTC, Clinical Proteomic Technologies for Cancer; IOTF, FDA Interagency Oncology Task Force; IVD, in vitro diagnostic device; IDE, investigational device exemption; PMA, premarket approval; FFPE, formalin-fixed, paraffin-embedded; LC-MRM-MS, liquid chromatography-multiple reaction monitoring mass spectrometry; LIF, laser-induced fluorescence; SID-MS, stable isotope dilution mass spectrometry.