CPTACClinical Proteomic Technology Assessment for Cancer (National Cancer Institute)
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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 paper is an example of the types of critiques that CPTAC's efforts can address.
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.
Because the advantages of eliminating interference are so substantial, the rigorous demonstration of this capability would appear to be a key item on the agenda of research groups such as the CPTAC consortium.
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.g., the interlaboratory reproducibility.
[15] Nonstandard abbreviations: FDA, US Food and Drug Administration; MS, mass spectrometry; CPTAC, Clinical Proteomic Technology Assessment for Cancer; IDE, investigational device exemption.
[2] Nonstandard abbreviations: FDA, US Food and Drug Administration; NCI, National Cancer Institute; PLCO, Prostate, Lung, Colon, Ovary study; RCT, randomized controlled clinical trial; WHI, Women's Health Initiative; CARET, Carotene and Retinol Efficacy Trial; PRoBE, prospective-specimen-collection, retrospective-blinded-evaluation; CPTAC, Clinical Proteomic Technology Assessment for Cancer; caHUB, Cancer Human Biobank.
Next steps for the CPTAC center network include gathering additional information on the variability of proteomics platforms.
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.