Expert consensus on the detection and clinical application of tumor mutational burden
As an emerging biomarker, tumor mutational burden (TMB) has attracted increasing attention from clinicians in predicting the efficacy of tumor immunotherapy. Currently, TMB is detected primarily by whole-exome sequencing or targeted panel sequencing on high-throughput sequencing platforms. However, the lack of uniformity in detection methods, threshold settings, and reporting formats, as well as the significant differences in TMB values among different cancer types, have hindered the standardized application of this biomarker in clinical practice. This consensus focuses on the definition, standardization of detection, clinical significance, and limitations of TMB, and provides consensus recommendations for the clinical application of TMB in real-world practice in China. This consensus is aimed at helping clinicians and laboratory personnel understand the clinical significance and testing standards of TMB, promoting more accurate interpretation of test results, and improving patient care.
Authors
- Wang Yao (ORCID: https://orcid.org/0000-0003-1776-3031)
- Ziming Li (ORCID: https://orcid.org/0000-0002-3647-8140)
- Donglai Lv (ORCID: https://orcid.org/0000-0002-3816-6319)
- Liyun Miao
- Dongmei Yuan
- X. Li
- Yongfang Yao (ORCID: https://orcid.org/0000-0001-6455-1213)
- X. Pu
- Zhengfei Zhu
- Jing Cai (ORCID: https://orcid.org/0000-0002-6792-4959)
- Zhefeng Liu
- Shengjie Yang (ORCID: https://orcid.org/0000-0001-6398-317X)
- Enyong Dai (ORCID: https://orcid.org/0000-0002-5263-3454)
- X. Niu
- R Zhang
- Chunqiang Xu (ORCID: https://orcid.org/0000-0002-2564-2689)
- Rui Ge (ORCID: https://orcid.org/0000-0001-7574-7609)
- Chuanhao Tang (ORCID: https://orcid.org/0000-0002-4219-3790)
- Lingfeng Min
- Biao Liu (ORCID: https://orcid.org/0000-0003-3477-6782)
- Bo Wang
- Y L Wang
- G. Wang
- Xiaomin Feng (ORCID: https://orcid.org/0009-0009-8547-5235)
- Zhigang Wu (ORCID: https://orcid.org/0000-0002-6782-9249)
- Lu Yin (ORCID: https://orcid.org/0000-0002-5075-5263)
- Xi Chen (ORCID: https://orcid.org/0000-0002-8523-3967)
- Heng Zhang (ORCID: https://orcid.org/0000-0002-0103-2173)
- Fan Wu (ORCID: https://orcid.org/0009-0003-5109-5118)
- Yanfang Li (ORCID: https://orcid.org/0000-0002-1487-365X)
- Chao Zhang (ORCID: https://orcid.org/0000-0003-2776-5647)
- Jinpu Yu
- Aijun Liu (ORCID: https://orcid.org/0000-0002-0683-4247)
- Xi Shi (ORCID: https://orcid.org/0000-0003-4648-8649)
- Wei Liu (ORCID: https://orcid.org/0000-0002-7409-0948)
- Jianzhong Chen (ORCID: https://orcid.org/0000-0002-8232-7298)
- Zhongwu Li (ORCID: https://orcid.org/0000-0002-7484-7533)
- Qi Wei (ORCID: https://orcid.org/0000-0002-0797-1657)
- Wenjun Yang
- Junli Xue
- Youcai Zhu (ORCID: https://orcid.org/0000-0002-7925-9650)
- Bo Lv (ORCID: https://orcid.org/0000-0001-9971-5126)
- Yue Hao (ORCID: https://orcid.org/0000-0002-3728-3927)
- Weiwen Li (ORCID: https://orcid.org/0000-0002-2830-8096)
- Fan Xia (ORCID: https://orcid.org/0000-0001-6464-5818)
- Lili Mao (ORCID: https://orcid.org/0000-0001-8712-7036)
- Si L (ORCID: https://orcid.org/0000-0001-9352-5452)
- Xiaobin Cui (ORCID: https://orcid.org/0009-0008-1690-0018)
- Xueping Xiang
- Yinbin Zhang
- Jing Kang (ORCID: https://orcid.org/0000-0002-6591-2401)
- Ming Zhao (ORCID: https://orcid.org/0009-0007-3559-4901)
- Tangfeng Lv (ORCID: https://orcid.org/0009-0003-0987-6770)
- Chan Xiang
- Xiaodong Jiao
- Gu Jin (ORCID: https://orcid.org/0009-0004-7786-1527)
- Huajuan Ruan
- Huijing Feng (ORCID: https://orcid.org/0000-0001-5099-2739)
- Zhaofeng Wang (ORCID: https://orcid.org/0009-0008-4776-4768)
- Anwen Liu (ORCID: https://orcid.org/0009-0004-9534-2317)
- Yanwen Yao
- Binbin Song
- Xuewen Liu
- Yongheng Li (ORCID: https://orcid.org/0009-0007-7812-087X)
- XINQING LIN
- Nong Yang
- Ling Xu (ORCID: https://orcid.org/0000-0002-5097-8256)
- Y. Fang
- Y. Ji
- Qian Chu
- Meiyu Fang
- Zhijie Wang (ORCID: https://orcid.org/0009-0009-9127-1044)
- Weizhong Gu
- Shirong Zhang
- Yun Gu
- Rongbo Lin
- Weiwei Pan
- Bihui Li
- Xuelei Ma
- Xixu Zhu
- Jingxun Wu
- Yingshi Piao
- Xiaofeng Chen
- Bin Lian
- Jianfei Fu
- Y. Liu
- Cong Wang
- Yongchang Zhang
- Weixing Li
- Yongjie Zhu
- Xiaoyan Li
- Shuangshuang Wang
- Long Huang
- Jisheng Li
- Xing Liu
- Jing Cai
- Hongbing Liu
- Wenfeng Li
- Jiandong Wang
- Jingping Yuan
- Yu Chen
- Ping Zhan
- Wenfeng Fang
- Pingli Sun
- Lin Shi
- Peng Shen
- Gen Lin
- Chuangzhou Rao
- Yu Zhang
- Yuchen Han
- Hui Guo
- Min Deng
- Rui Meng
- Mingxiang Ye
- Yiping Zhang
- Qing Ji
- Feng Wang
- Wenxian Wang
- Lin Wu
- Yingying Du
- Wen Li
- Ke Wang
- Miao Li
- Zhen Wang
- Yong Song
- Xiaotong Hu
- Xiaojia Wang
- Hong Mou
- Bin Wan
- Wei Wang
- Chengzhi Zhou
- Shengxiang Ren
- Qian Wang
- Liping Zhang
- Kainan Li
- Jia Wei
- Yu Han
- Peng Luo
- Jingjing Liu
- Jin Zhou
- Zhenying Guo
- Hong Wang
- Yi Shen
- Lin Wang
- Fei Pang
- Jing Zhao
- Jian Zhang
- Li Wang
- Li Lin
- Zhonghua Wang
- Peng Li
- Zhang Zhang
- Dejian Gu
- Xiuyu Cai
- Zhengbo Song
- Hong Qiu
- Dong Wang
- Wenzhao Zhong
- Zongyang Yu
- Liping Wang
- Weiguo Long
- Junping Zhang
Institutions
- Hebei Medical University (CN)
- Tongji University (CN)
- Beijing Tongren Hospital (CN)
- Fujian Medical University (CN)
- Nanjing University of Chinese Medicine (CN)
- Union Hospital (HK)
- University of Nottingham Ningbo China (CN)
- Central South University (CN)
- Nanchang University (CN)
- Army Medical University (CN)
- Shandong University (CN)
- Harbin Medical University (CN)
- Sun Yat-sen University (CN)
- Jinan University (CN)
- Guilin Medical University (CN)
- Shanghai Jiao Tong University (CN)
- Capital Medical University (CN)
- Anhui Medical University (CN)
- Chinese Academy of Sciences (CN)
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Peking University (CN)
- Sichuan University (CN)
- Fudan University (CN)
- National Health and Family Planning Commission (CN)
- Wenzhou Medical University (CN)
- Nanjing General Hospital of Nanjing Military Command (CN)
- Peking Union Medical College Hospital (CN)
- First Affiliated Hospital of Wenzhou Medical University (CN)
- Sir Run Run Shaw Hospital (CN)
- Tianjin Medical University Cancer Institute and Hospital (CN)
- Leshan Normal University (CN)
- Shanghai Chest Hospital (CN)
- Chinese PLA General Hospital (CN)
- Beijing Jishuitan Hospital (CN)
- Huzhou Normal University (CN)
- Wuhan University (CN)
- Zhengzhou University (CN)
- First Affiliated Hospital of Xiamen University (CN)
- Beijing Tian Tan Hospital (CN)
- National Clinical Research Center for Digestive Diseases (CN)
- Shanghai Medical Information Center (CN)
- Nanjing Children's Hospital (CN)
- Jiaxing University (CN)
- Fudan University Shanghai Cancer Center (CN)
- Peking University Cancer Hospital (CN)
- Fuyang City People's Hospital (CN)
- Qinghai No.3 People's Hospital (CN)
- Tongde Hospital of Zhejiang Province (CN)
- First Affiliated Hospital of Guangzhou Medical University (CN)
- 117th Hospital of People's Liberation Army (CN)
- Jilin Province Tumor Hospital (CN)
- Zhejiang Cancer Hospital (CN)
- Huadong Hospital (CN)
- Shanghai Changzheng Hospital (CN)
- Nanjing Maternity and Child Health Care Hospital (CN)
- Nanfang Hospital (CN)
- Affiliated Hospital of Hangzhou Normal University (CN)
- Third Affiliated Hospital of Harbin Medical University (CN)
- Huzhou Central Hospital (CN)
- Fourth Hospital of Hebei Medical University (CN)
- Second Affiliated Hospital of Nanchang University (CN)
- Nanjing Drum Tower Hospital (CN)
- Lishui Central Hospital (CN)
- Children's Hospital of Zhejiang University (CN)
- First Affiliated Hospital of Xinxiang Medical University (CN)
- Hunan Cancer Hospital (CN)
- Suzhou Municipal Hospital (CN)
- Shandong Provincial Hospital (CN)
- Xinqiao Hospital (CN)
- Sichuan Cancer Hospital (CN)
- Jinhua Academy of Agricultural Sciences (CN)
- Fuzhou General Hospital of Nanjing Military Command (CN)
- Zhujiang Hospital (CN)
- Zhejiang University Medical College Affiliated Stomatological Hospital (CN)
- First Affiliated Hospital of Xi'an Jiaotong University (CN)
- Zhoushan Hospital (CN)
- Zhongshan Hospital (CN)
- Shanghai Pulmonary Hospital (CN)
- Baotou Central Hospital (CN)
- Pudong Medical Center (CN)
- Zhejiang Shuren University (CN)
- Shanghai East Hospital (CN)
- The First Affiliated Hospital, Sun Yat-sen University (CN)
- Anhui Provincial Hospital (CN)
- Zhejiang Provincial People's Hospital (CN)
- Second Affiliated Hospital of Xi'an Jiaotong University (CN)
- Stomatology Hospital (CN)
- Peking University International Hospital (CN)
- First Affiliated Hospital of Anhui Medical University (CN)
- Women's Hospital, School of Medicine, Zhejiang University (CN)
- Northern Jiangsu People's Hospital (CN)
- Second Affiliated Hospital of Nanjing Medical University (CN)
- First Hospital of Jiaxing (CN)
- Peking University Shougang Hospital (CN)
- The First People's Hospital of Tianmen (CN)
- Renmin Hospital of Wuhan University (CN)
- Cancer Hospital of Chinese Academy of Medical Sciences (CN)
- Second Affiliated Hospital of Jilin University (CN)
- Chuxiong Normal University (CN)
- Henan Cancer Hospital (CN)
- Guangdong Academy of Medical Sciences (CN)
- Sun Yat-sen University Cancer Center (CN)
- Anhui Provincial Children's Hospital (CN)
- Ministry of Education (ET)
- Fujian Provincial Cancer Hospital (CN)
- Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine (CN)
- Zhengzhou People's Hospital (CN)
- Jiangsu Province Hospital (CN)
- Guizhou Provincial People's Hospital (CN)
- Nanjing Jiangning Hospital (CN)
- Third Xiangya Hospital (CN)
- Second Affiliated Hospital of Zhejiang University (CN)
- Zhejiang Taizhou Hospital (CN)
- Shanxi Academy of Medical Sciences (CN)
- Xijing Hospital (CN)
- Tongji Hospital (CN)
- Baotou Medical College (CN)
- Qilu Hospital of Shandong University (CN)
- Jinhua Central Hospital (CN)
- First Affiliated Hospital of Jinan University (CN)
- Union Hospital (CN)
- University of Chinese Academy of Sciences (CN)
- Hangzhou Medical College (CN)
- Hangzhou Cancer Hospital (CN)
- First Affiliated Hospital Zhejiang University (CN)
- State Key Laboratory of Biotherapy
- State Key Laboratory of Oncology in South China
- Huazhong University of Science and Technology (CN)
- Southern Medical University (CN)
- Zhejiang University (CN)
- Aksum University (ET)
- Yangzhou University (CN)
- Henan Medical University (CN)
- Taizhou University (CN)
- Nanjing Medical University (CN)
- Nanjing University (CN)
- China Medical University (CN)
- Guangzhou Medical University (CN)
- Silicon Labs (United States) (US)
- Air Force Medical University (CN)
Publication Details
- Journal
- Cancer Biology and Medicine
- Published
- 2026-02-17
- DOI
- https://doi.org/10.20892/j.issn.2095-3941.2025.0351
- Primary Topic
- Cancer Immunotherapy and Biomarkers
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- National Natural Science Foundation of China