全球癌症组织（GCC）关于组织中生物标志物检测验证（BAV）的建议。
Recommendations on biomarker assay validation (BAV) in tissues by GCC.
作者信息
Yuan Moucun, Liu Aihua, Xu Bin, Sales Kurt, Karnik Shane, Voelker Troy, Salha Danielle, Zimmer Jennifer, O'Dell Mark, Gorityala Shashank, Hays Amanda, Lester Todd, Reynolds Gregory, Tary-Lehmann Magdalena, Yu Mathilde, Roberge Martin, Malone Katherine, Patel Vimal, Love Iain, Lin Jenny, Diaz Manisha, Xu Tao, Garofolo Wei, McGregor Jessica, Leskovar Amanda, Kernstock Robert, Pellerin Mario, Brown Michael, Spytko Adriane, Lowes Stephen, Ambrose David, Dufield Dawn, Kane Cheikh, Veeramachaneni Rathna, Luna Marsha, Warrino Dominic, Dwivedi Varun, Xu Allan, Hyer Elizabeth, Iles Tracy, Majumdar Ritankar, Sikkema Daniel, Thomas Eric, Carlsson Annika, Dakappagari Naveen, Riccitelli Nathan, Marco Chantal Di, Bouhajib Mohammed, Iordachescu Adriana, Sanghvi Mitesh, Barton Hollie, Lavelle Amy, Dompkowski Elizabeth, Rundlett Stephen, Matys Katie, Sangster Tim, Turksma Annelies, Gu Weihua, Liu Jia, Hoffpauir Brian, Rocha Agostinho, Pirro John, Bergeron Jerome, O'Brien Kyla, Fang Xinping, Dong Kelly, Yamashita Jim
机构信息
PPD, part of Thermo Fisher Scientific, Richmond, VA, USA.
Resolian, Malvern, PA, USA.
出版信息
Bioanalysis. 2025 Apr;17(7):429-438. doi: 10.1080/17576180.2025.2471243. Epub 2025 Apr 18.
Biomarker analysis enables a deep understanding of physiological and biological processes and offers insights into pathological disease states and conditions. When measured in tissues, the spatial distribution of biomarkers may be evaluated. To meet regulatory and sponsor requirements, guidance on the approach to validation and the parameters to be evaluated is essential. The main goals of this GCC white paper are to disseminate the survey results discussed during the 16& 17GCC Closed Forums (2023 & 2024) and to provide recommendations from the GCC members on technical and regulatory considerations for the bioanalysis of biomarkers in tissues.
生物标志物分析有助于深入了解生理和生物学过程，并为病理疾病状态和情况提供见解。在组织中进行测量时，可以评估生物标志物的空间分布。为满足监管机构和申办方的要求，关于验证方法和待评估参数的指南至关重要。本GCC白皮书的主要目标是传播在第16届和第17届GCC闭门论坛（2023年和2024年）期间讨论的调查结果，并提供GCC成员关于组织中生物标志物生物分析的技术和监管考虑因素的建议。
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