The path to clinical proteomics research: integration of proteomics, genomics, clinical laboratory and regulatory science.
The path to clinical proteomics research: integration of proteomics, genomics, clinical laboratory and regulatory science.
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DOI：
10.3343/kjlm.2011.31.2.61
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发表时间：
2011-04
期刊：
影响因子：
--
通讯作者：
Rodriguez H
中科院分区：
文献类型：
--
作者：
Boja ES;Rodriguez H
对于癌症的检测、诊断和预后，迫切需要更好的生物标志物。虽然基因组学在理解疾病的分子基础方面取得了重大进展，但蛋白质组学将描绘细胞、蛋白质及其复杂的相互作用网络和潜在疾病的信号通路的功能单位。利用多维样品分离策略、质谱学和蛋白质微阵列对复杂生物体系中的数千种蛋白质进行定性和定量表征已经取得了很大的进展。对人类癌症蛋白质组图谱的高质量临床生物标本(如组织和生物液)进行比较/定量分析，可能通过其表达水平的改变、翻译后修饰以及不同形式的蛋白质变异来揭示与这种疾病有关的蛋白质/多肽生物标志物。尽管蛋白质组学技术取得了进步，但在生物标记物开发管道的每一步仍然存在主要障碍。美国国家癌症研究所的癌症临床蛋白质组技术计划(NCI-CPTC)在缩小生物标记物发现和鉴定之间的差距方面迈出了关键的一步，引入了正在筹备的临床前“验证”阶段，与临床实验室组织合作制定和实施共同标准，并与美国食品和药物管理局(FDA)共同制定监管科学文件，以教育蛋白质组学社区多重分析的分析评估要求，以确保这些测试的预期用途的安全性和有效性。
Better biomarkers are urgently needed to cancer detection, diagnosis, and prognosis. While the genomics community is making significant advances in understanding the molecular basis of disease, proteomics will delineate the functional units of a cell, proteins and their intricate interaction network and signaling pathways for the underlying disease. Great progress has been made to characterize thousands of proteins qualitatively and quantitatively in complex biological systems by utilizing multi-dimensional sample fractionation strategies, mass spectrometry and protein microarrays. Comparative/quantitative analysis of high-quality clinical biospecimen (e.g., tissue and biofluids) of human cancer proteome landscape has the potential to reveal protein/peptide biomarkers responsible for this disease by means of their altered levels of expression, post-translational modifications as well as different forms of protein variants. Despite technological advances in proteomics, major hurdles still exist in every step of the biomarker development pipeline. The National Cancer Institute's Clinical Proteomic Technologies for Cancer initiative (NCI-CPTC) has taken a critical step to close the gap between biomarker discovery and qualification by introducing a pre-clinical "verification" stage in the pipeline, partnering with clinical laboratory organizations to develop and implement common standards, and developing regulatory science documents with the US Food and Drug Administration to educate the proteomics community on analytical evaluation requirements for multiplex assays in order to ensure the safety and effectiveness of these tests for their intended use.
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