Expert consensus on the detection and clinical application of tumor mutational burden

Zhenying Guo^#¹, Chunwei Xu^#², Shirong Zhang^#³, Yue Hao^#⁴, Xiaotong Hu⁵, Ming Zhao⁶, Chan Xiang⁷, Yingshi Piao⁸, Pingli Sun⁹, Xueping Xiang¹⁰, Jing Zhao¹¹, Huanwen Wu¹², Weixing Li¹³, Jinpu Yu¹⁴, Jingping Yuan¹⁵, Shuangshuang Wang¹⁶, Cong Wang¹⁷, Yun Gu¹⁸, Bingjian Lv¹⁹, Liping Zhang²⁰, Yueping Liu²¹, Xiaobin Cui²², Weizhong Gu²³, Yining Li²⁴, Wei Wang²⁵, Wenjun Yang²⁶, Weiguo Long²⁷, Jingjing Xiang²⁸, Hong Mou²⁹, Biao Liu³⁰, Huajuan Ruan³¹, Yubin Wang³², Yongjie Zhu³³, Feng Wang³⁴, Zhonghua Wang³⁵, Xiaomin Feng¹⁸, Xing Liu³⁶, Peng Li³⁷, Min Deng³⁸, Bin Lian³⁹, Lili Mao³⁹, Qian Wang⁴⁰, Wenxian Wang⁴, Zhengbo Song⁴, Ziming Li⁴¹, Wenzhao Zhong⁴², Zhijie Wang⁴³, Shengxiang Ren⁴⁴, Wenfeng Fang⁴⁵, Yongchang Zhang⁴⁶, Jingjing Liu⁴⁷, Xiuyu Cai⁴⁸, Anwen Liu⁴⁹, Wen Li⁵⁰, Ping Zhan⁵¹, Hongbing Liu⁵¹, Tangfeng Lv⁵¹, Liyun Miao⁵², Lingfeng Min⁵³, Yu Chen⁵⁴, Yu Zhang⁵⁵, Feng Wang⁵⁶, Zhansheng Jiang⁵⁷, Gen Lin⁵⁴, Long Huang⁴⁹, Xingxiang Pu⁵⁸, Rongbo Lin⁵⁴, Weifeng Liu⁵⁹, Chuangzhou Rao⁶⁰, Dongqing Lv⁶¹, Zongyang Yu⁶², Peng Shen⁶³, Xiaoyan Li⁶⁴, Chuanhao Tang⁶⁵, Chengzhi Zhou⁶⁶, Junping Zhang⁶⁷, Junli Xue⁶⁸, Hui Guo⁶⁹, Qian Chu⁷⁰, Rui Meng⁷¹, Jingxun Wu⁷², Rui Zhang⁷³, Jin Zhou⁷⁴, Zhengfei Zhu⁷⁵, Yongheng Li⁷⁶, Hong Qiu⁷⁰, Fan Xia⁷⁵, Yuanyuan Lu⁷⁷, Xiaofeng Chen⁷⁸, Rui Ge⁷⁹, Enyong Dai⁸⁰, Yu Han⁸¹, Jian Zhang⁸², Yinghua Ji⁸³, Xianbin Liang⁸⁴, Hongmei Zhang⁸⁵, Xuelei Ma⁸⁵, Xuewen Liu⁸⁶, Yu Yao⁸⁷, Peng Luo⁸², Weiwei Pan⁸⁸, Fei Pang⁸⁹, Fan Wu⁹⁰, Dejian Gu⁹¹, Li Wang⁹¹, Liping Wang⁹², Youcai Zhu⁹³, Li Lin⁶⁵, Weiwen Li⁹⁴, Xinqing Lin⁶⁶, Jing Cai⁴⁹, Ling Xu⁹⁵, Jisheng Li⁹⁶, Xiaodong Jiao⁹⁷, Kainan Li⁹⁸, Jia Wei⁹⁹, Huijing Feng⁶⁷, Lin Wang¹⁰⁰, Yingying Du¹⁰¹, Wang Yao¹⁰², Xuefei Shi¹⁰³, Xiaomin Niu⁴¹, Dongmei Yuan⁵¹, Yanwen Yao⁵¹, Yinbin Zhang⁶⁹, Binbin Song¹⁰⁴, Wenfeng Li¹⁰⁵, Jianfei Fu¹⁰⁶, Hong Wang¹⁰⁷, Mingxiang Ye⁵¹, Dong Wang⁵¹, Zhaofeng Wang⁵¹, Qing Ji⁴, Yuan Fang¹⁰⁸, Qing Wei⁴, Zhen Wang¹⁰⁹, Bin Wan¹¹⁰, Donglai Lv¹¹¹, Xiaofeng Li⁹³, Shengjie Yang¹¹², Jing Kang⁴², Jiatao Zhang⁴², Chao Zhang⁴², Lin Shi¹¹³, Yina Wang¹¹⁴, Bihui Li¹¹⁵, Zhang Zhang¹¹⁶, Ke Wang^{117

118}, Zhefeng Liu¹⁰⁷, Nong Yang⁴⁶, Lin Wu⁵⁸, Xiaobing Chen¹¹⁹, Gu Jin¹²⁰, Zhongwu Li¹²¹, Miao Li¹²², Guansong Wang¹²³, Jiandong Wang¹²⁴, Meiyu Fang⁴, Yong Fang¹²⁵, Xiaojia Wang⁴, Jing Chen⁷¹, Yiping Zhang⁴, Xixu Zhu¹⁰⁹, Yi Shen¹²⁶, Shenglin Ma¹²⁷, Biyun Wang¹²⁸, Lu Si³⁹, Yong Song⁵¹, Yuanzhi Lu¹²⁹, Aijun Liu¹³⁰, Yuchen Han⁷

Affiliations

¹ Cancer Center, Department of Pathology, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou 310014, China.
² Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou 310022, China.
³ Translational Medicine Research Center, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou First People's Hospital, Cancer Center, Westlake University School of Medicine, Hangzhou 310006, China.
⁴ Department of Chemotherapy, Chinese Academy of Sciences University Cancer Hospital (Zhejiang Cancer Hospital), Hangzhou 310022, China.
⁵ Department of Pathology, Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou 310016, China.
⁶ Ningbo Clinical Pathology Diagnosis Center, Ningbo 315100, China.
⁷ Department of Pathology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.
⁸ Department of Pathology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.
⁹ Department of Pathology, The Second Hospital of Jilin University, Changchun 130041, China.
¹⁰ Department of Pathology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310009, China.
¹¹ Department of Pathology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310003, China.
¹² Department of Pathology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100730, China.
¹³ Laboratory Medicine Center, Zhejiang Center for Clinical Laboratory, Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical College, Hangzhou 310014, China.
¹⁴ Department of Cancer Molecular Diagnostics Core, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China.
¹⁵ Department of Pathology, Renmin Hospital of Wuhan University, Wuhan 430060, China.
¹⁶ Department of Pathology, Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing 210029, China.
¹⁷ Department of Pathology, The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Nanjing 210029, China.
¹⁸ Department of Pathology, Women's Hospital of Nanjing Medical University, Nanjing Women and Children's Healthcare Hospital, Nanjing 210004, China.
¹⁹ Department of Surgical Pathology Women's Hospital, School of Medicine, Zhejiang University, Hangzhou 310006, of China.
²⁰ Department of Pathology, Shanghai Pudong Hospital, School of Medicine, Fudan University, Shanghai 201399, China.
²¹ Department of Pathology, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050011, China.
²² Department of Pathology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing 210008, China.
²³ Department of Pathology, Children's Hospital Zhejiang University School of Medicine, Hangzhou 310005, China.
²⁴ Department of Pathology, Stomatology Hospital, School of Stomatology, Zhejiang University, Hangzhou 310000, China.
²⁵ Department of Pathology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, China.
²⁶ Department of Pathology, Affiliated Hospital of Hangzhou Normal University, Hangzhou 310000, China.
²⁷ Department of Pathology, The People's Hospital of Leshan, Leshan 614000, China.
²⁸ Department of Pathology, Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine, Hangzhou 310006, China.
²⁹ Department of Pathology, Chun'an First People's Hospital, Hangzhou 311700, China.
³⁰ Department of Pathology, The Affiliated Suzhou Hospital, Nanjing Medical University, Suzhou 215006, China.
³¹ Department of Pathology, The First People's Hospital of Hangzhou Lin'an District, Affiliated Lin'an People's Hospital, Hangzhou Medical College, Hangzhou 311300, China.
³² Department of Pathology, Tiantai County People's Hospital, Taizhou 317200, China.
³³ Department of Pathology, First People's Hospital of Aksu, Aksu 843000, China.
³⁴ Department of Pathology, Xianju People's Hospital, Zhejiang Southeast Campus of Zhejiang Provincial People's Hospital, Affiliated Xianju's Hospital, Hangzhou Medical College, Taizhou 317300, China.
³⁵ Department of Pathology, Dinghai Branch of Zhejiang Provincial People's Hospital, Zhoushan 316000, China.
³⁶ Department of Pathology, Shulan (Hangzhou) Hospital, Hangzhou 310022, China.
³⁷ Department of Pathology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China.
³⁸ Department of Pathology, Zhejiang Provincial People's Hospital (Fuyang Campus), Hangzhou 311400, China.
³⁹ Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital & Institute, Beijing 100142, China.
⁴⁰ Department of Respiratory Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing 210029, China.
⁴¹ Department of Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.
⁴² Guangdong Lung Cancer Institute, Guangdong Provincial Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, Guangzhou 510080, China.
⁴³ State Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
⁴⁴ Department of Medical Oncology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai 200433, China.
⁴⁵ Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China.
⁴⁶ Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha 410013, China.
⁴⁷ Department of Thoracic Cancer, Jilin Cancer Hospital, Changchun 130012, China.
⁴⁸ Department of VIP Inpatient, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China.
⁴⁹ Department of Oncology, Second Affiliated Hospital of Nanchang University, Nanchang 330006, China.
⁵⁰ Key Laboratory of Respiratory Disease of Zhejiang Province, Department of Respiratory and Critical Care Medicine, Second Affiliated Hospital of Zhejiang University School of Medicine, Cancer Center, Zhejiang University, Hangzhou 310009, China.
⁵¹ Department of Respiratory Medicine, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, China.
⁵² Department of Respiratory Medicine, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China.
⁵³ Department of Respiratory Medicine, Clinical Medical School of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou 225001, China.
⁵⁴ Department of Medical Oncology, Fujian Medical University Cancer Hospital & Fujian Cancer Hospital, Fuzhou 350014, China.
⁵⁵ Department of Oncology, Guizhou Provincial People's Hospital, Guiyang 550001, China.
⁵⁶ Department of Internal Medicine, Cancer Center of PLA, Qinhuai Medical Area, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, China.
⁵⁷ Department of Integrative Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China.
⁵⁸ The Second Department of Thoracic Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha 410013, China.
⁵⁹ Department of Orthopedic Oncology Surgery, Beijing Ji shui tan Hospital, Peking University, Beijing 100035, China.
⁶⁰ Department of Radiotherapy and Chemotherapy, Hwamei Hospital, University of Chinese Academy of Sciences, Ningbo 315010, China.
⁶¹ Department of Pulmonary Medicine, Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China.
⁶² Department of Respiratory Medicine, the 900th Hospital of the Joint Logistics Team (the Former Fuzhou General Hospital), Fujian Medical University, Fuzhou 350025, China.
⁶³ Department of Oncology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.
⁶⁴ Department of Oncology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100700, China.
⁶⁵ Department of Medical Oncology, Peking University International Hospital, Beijing 102206, China.
⁶⁶ State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510300, China.
⁶⁷ Department of Thoracic Oncology, Shanxi Academy of Medical Sciences, Shanxi Bethune Hospital, Taiyuan 030032, China.
⁶⁸ Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200123, China.
⁶⁹ Department of Oncology, The Second Affiliated Hospital of Medical College, Xi'an Jiaotong University, Xi'an 710004, China.
⁷⁰ Department of Oncology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
⁷¹ Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.
⁷² Department of Medical Oncology, The First Affiliated Hospital of Medicine, Xiamen University, Xiamen 361003, China.
⁷³ Department of Medical Oncology, Cancer Hospital of China Medical University, Shenyang 110042, China.
⁷⁴ Department of Medical Oncology, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology, Chengdu 610041, China.
⁷⁵ Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
⁷⁶ Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing 100142, China.
⁷⁷ State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an 710032, China.
⁷⁸ Department of Oncology, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing 210029, China.
⁷⁹ Department of General Surgery, Huadong Hospital Affiliated to Fudan University, Shanghai 200040, China.
⁸⁰ Department of Oncology and Hematology, China-Japan Union Hospital of Jilin University, Changchun 130033, China.
⁸¹ Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, China.
⁸² Department of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.
⁸³ Department of Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang 453000, China.
⁸⁴ Department of Oncology, The Third People's Hospital of Zhengzhou, Zhengzhou 450000, China.
⁸⁵ Department of Biotherapy, State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, China.
⁸⁶ Department of Oncology, the Third Xiangya Hospital, Central South University, Changsha 410013, China.
⁸⁷ Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.
⁸⁸ Department of Cell Biology, College of Medicine, Jiaxing University, Jiaxing 314001, China.
⁸⁹ Department of Medical, Shanghai OrigiMed Co, Ltd, Shanghai 201114, China.
⁹⁰ Department of Medical, Menarini Silicon Biosystems SpA, Shanghai 200333, China.
⁹¹ Department of Medical, Geneplus-Beijing, Beijing 102200, China.
⁹² Department of Oncology, Baotou Cancer Hospital, Baotou 014000, China.
⁹³ Department of Thoracic Disease Diagnosis and Treatment Center, Zhejiang Rongjun Hospital, The Third Affiliated Hospital of Jiaxing University, Jiaxing 314000, China.
⁹⁴ Department of Oncology, Lishui Municipal Central Hospital, Lishui 323000, China.
⁹⁵ Department of Interventional Pulmonary Diseases, Anhui Chest Hospital, Hefei 230011, China.
⁹⁶ Department of Medical Oncology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250012, China.
⁹⁷ Department of Medical Oncology, Shanghai Changzheng Hospital, Naval Medical University, Shanghai 200070, China.
⁹⁸ Department of Oncology, Shandong Provincial Third Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250031, China.
⁹⁹ Department of The Comprehensive Cancer Center, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China.
¹⁰⁰ Department of Pathology, Shanxi Academy of Medical Sciences, Shanxi Bethune Hospital, Taiyuan 030032, China.
¹⁰¹ Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.
¹⁰² Department of Interventional Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510060, China.
¹⁰³ Department of Respiratory Medicine, Huzhou Hospital, Zhejiang University School of Medicine, Huzhou 313000, China.
¹⁰⁴ Department of Medical Oncology, The Affiliated Hospital of Jiaxing University, Jiaxing 314000, China.
¹⁰⁵ Department of Radiation Oncology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China.
¹⁰⁶ Department of Medical Oncology, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua 321000, China.
¹⁰⁷ Senior Department of Oncology, The 5th Medical Center of PLA General Hospital, Beijing 100071, China.
¹⁰⁸ Department of Pathology, Anhui Provincial Children's Hospital, Hefei 230051, China.
¹⁰⁹ Department of Radiation Oncology, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, China.
¹¹⁰ Department of Respiratory Medicine, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing 210002, China.
¹¹¹ Department of Clinical Oncology, The 901 Hospital of Joint Logistics Support Force of People Liberation Army, Hefei 230031, China.
¹¹² Department of Thoracic Surgery, Chuxiong Yi Autonomous Prefecture People's Hospital, Chuxiong 675000, China.
¹¹³ Department of Respiratory Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
¹¹⁴ Department of Oncology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310000, China.
¹¹⁵ Department of Oncology, The Second Affiliated Hospital of Guilin Medical University, Guilin 541199, China.
¹¹⁶ International Cooperative Laboratory of Traditional Chinese Medicine Modernization and Innovative Drug Discovery of Chinese Ministry of Education (MOE), Guangzhou City Key Laboratory of Precision Chemical Drug Development, School of Pharmacy, Jinan University, Guangzhou 510632, China.
¹¹⁷ National Health Commission (NHC) Key Laboratory of Nuclear Medicine, Jiangsu Key Laboratory of Molecular Nuclear Medicine, Jiangsu Institute of Nuclear Medicine, Wuxi 214063, China.
¹¹⁸ Department of Radiopharmaceuticals, School of Pharmacy, Nanjing Medical University, Nanjing 210000, China.
¹¹⁹ Department of Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou 450008, China.
¹²⁰ Department of Bone and Soft-tissue Surgery, Chinese Academy of Sciences University Cancer Hospital (Zhejiang Cancer Hospital), Hangzhou 310022, China.
¹²¹ Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Pathology, Peking University Cancer Hospital & Institute, Beijing 100142, China.
¹²² Department of Oncology, The Cancer Hospital of Qinghai Province, Xining 810001, China.
¹²³ Institute of Respiratory Diseases, Xinqiao Hospital, Third Military Medical University, Chongqing 400037, China.
¹²⁴ Department of Pathology, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, China.
¹²⁵ Department of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou 310016, China.
¹²⁶ Department of Thoracic Surgery, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, China.
¹²⁷ Department of Oncology, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou Cancer Hospital, Cancer Center, Westlake University School of Medicine, Hangzhou 310006, China.
¹²⁸ Department of Breast Cancer and Urological Medical Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
¹²⁹ Department of Clinical Pathology, The First Affiliated Hospital of Jinan University, Guangzhou 510630, China.
¹³⁰ Senior Department of Pathology, the 7th Medical Center of PLA General Hospital, Beijing 100700, China.

^# Contributed equally.

PMID: 41704094
PMCID: PMC12980037
DOI: 10.20892/j.issn.2095-3941.2025.0351

Expert consensus on the detection and clinical application of tumor mutational burden

Zhenying Guo et al. Cancer Biol Med. 2026.

. 2026 Feb 17;23(2):218-246.

doi: 10.20892/j.issn.2095-3941.2025.0351.

Authors

Affiliations

¹ Cancer Center, Department of Pathology, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou 310014, China.
² Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou 310022, China.
³ Translational Medicine Research Center, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou First People's Hospital, Cancer Center, Westlake University School of Medicine, Hangzhou 310006, China.
⁴ Department of Chemotherapy, Chinese Academy of Sciences University Cancer Hospital (Zhejiang Cancer Hospital), Hangzhou 310022, China.
⁵ Department of Pathology, Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou 310016, China.
⁶ Ningbo Clinical Pathology Diagnosis Center, Ningbo 315100, China.
⁷ Department of Pathology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.
⁸ Department of Pathology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.
⁹ Department of Pathology, The Second Hospital of Jilin University, Changchun 130041, China.
¹⁰ Department of Pathology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310009, China.
¹¹ Department of Pathology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310003, China.
¹² Department of Pathology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100730, China.
¹³ Laboratory Medicine Center, Zhejiang Center for Clinical Laboratory, Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical College, Hangzhou 310014, China.
¹⁴ Department of Cancer Molecular Diagnostics Core, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China.
¹⁵ Department of Pathology, Renmin Hospital of Wuhan University, Wuhan 430060, China.
¹⁶ Department of Pathology, Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing 210029, China.
¹⁷ Department of Pathology, The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Nanjing 210029, China.
¹⁸ Department of Pathology, Women's Hospital of Nanjing Medical University, Nanjing Women and Children's Healthcare Hospital, Nanjing 210004, China.
¹⁹ Department of Surgical Pathology Women's Hospital, School of Medicine, Zhejiang University, Hangzhou 310006, of China.
²⁰ Department of Pathology, Shanghai Pudong Hospital, School of Medicine, Fudan University, Shanghai 201399, China.
²¹ Department of Pathology, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050011, China.
²² Department of Pathology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing 210008, China.
²³ Department of Pathology, Children's Hospital Zhejiang University School of Medicine, Hangzhou 310005, China.
²⁴ Department of Pathology, Stomatology Hospital, School of Stomatology, Zhejiang University, Hangzhou 310000, China.
²⁵ Department of Pathology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, China.
²⁶ Department of Pathology, Affiliated Hospital of Hangzhou Normal University, Hangzhou 310000, China.
²⁷ Department of Pathology, The People's Hospital of Leshan, Leshan 614000, China.
²⁸ Department of Pathology, Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine, Hangzhou 310006, China.
²⁹ Department of Pathology, Chun'an First People's Hospital, Hangzhou 311700, China.
³⁰ Department of Pathology, The Affiliated Suzhou Hospital, Nanjing Medical University, Suzhou 215006, China.
³¹ Department of Pathology, The First People's Hospital of Hangzhou Lin'an District, Affiliated Lin'an People's Hospital, Hangzhou Medical College, Hangzhou 311300, China.
³² Department of Pathology, Tiantai County People's Hospital, Taizhou 317200, China.
³³ Department of Pathology, First People's Hospital of Aksu, Aksu 843000, China.
³⁴ Department of Pathology, Xianju People's Hospital, Zhejiang Southeast Campus of Zhejiang Provincial People's Hospital, Affiliated Xianju's Hospital, Hangzhou Medical College, Taizhou 317300, China.
³⁵ Department of Pathology, Dinghai Branch of Zhejiang Provincial People's Hospital, Zhoushan 316000, China.
³⁶ Department of Pathology, Shulan (Hangzhou) Hospital, Hangzhou 310022, China.
³⁷ Department of Pathology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China.
³⁸ Department of Pathology, Zhejiang Provincial People's Hospital (Fuyang Campus), Hangzhou 311400, China.
³⁹ Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital & Institute, Beijing 100142, China.
⁴⁰ Department of Respiratory Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing 210029, China.
⁴¹ Department of Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.
⁴² Guangdong Lung Cancer Institute, Guangdong Provincial Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, Guangzhou 510080, China.
⁴³ State Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
⁴⁴ Department of Medical Oncology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai 200433, China.
⁴⁵ Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China.
⁴⁶ Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha 410013, China.
⁴⁷ Department of Thoracic Cancer, Jilin Cancer Hospital, Changchun 130012, China.
⁴⁸ Department of VIP Inpatient, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China.
⁴⁹ Department of Oncology, Second Affiliated Hospital of Nanchang University, Nanchang 330006, China.
⁵⁰ Key Laboratory of Respiratory Disease of Zhejiang Province, Department of Respiratory and Critical Care Medicine, Second Affiliated Hospital of Zhejiang University School of Medicine, Cancer Center, Zhejiang University, Hangzhou 310009, China.
⁵¹ Department of Respiratory Medicine, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, China.
⁵² Department of Respiratory Medicine, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China.
⁵³ Department of Respiratory Medicine, Clinical Medical School of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou 225001, China.
⁵⁴ Department of Medical Oncology, Fujian Medical University Cancer Hospital & Fujian Cancer Hospital, Fuzhou 350014, China.
⁵⁵ Department of Oncology, Guizhou Provincial People's Hospital, Guiyang 550001, China.
⁵⁶ Department of Internal Medicine, Cancer Center of PLA, Qinhuai Medical Area, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, China.
⁵⁷ Department of Integrative Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China.
⁵⁸ The Second Department of Thoracic Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha 410013, China.
⁵⁹ Department of Orthopedic Oncology Surgery, Beijing Ji shui tan Hospital, Peking University, Beijing 100035, China.
⁶⁰ Department of Radiotherapy and Chemotherapy, Hwamei Hospital, University of Chinese Academy of Sciences, Ningbo 315010, China.
⁶¹ Department of Pulmonary Medicine, Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China.
⁶² Department of Respiratory Medicine, the 900th Hospital of the Joint Logistics Team (the Former Fuzhou General Hospital), Fujian Medical University, Fuzhou 350025, China.
⁶³ Department of Oncology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.
⁶⁴ Department of Oncology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100700, China.
⁶⁵ Department of Medical Oncology, Peking University International Hospital, Beijing 102206, China.
⁶⁶ State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510300, China.
⁶⁷ Department of Thoracic Oncology, Shanxi Academy of Medical Sciences, Shanxi Bethune Hospital, Taiyuan 030032, China.
⁶⁸ Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200123, China.
⁶⁹ Department of Oncology, The Second Affiliated Hospital of Medical College, Xi'an Jiaotong University, Xi'an 710004, China.
⁷⁰ Department of Oncology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
⁷¹ Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.
⁷² Department of Medical Oncology, The First Affiliated Hospital of Medicine, Xiamen University, Xiamen 361003, China.
⁷³ Department of Medical Oncology, Cancer Hospital of China Medical University, Shenyang 110042, China.
⁷⁴ Department of Medical Oncology, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology, Chengdu 610041, China.
⁷⁵ Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
⁷⁶ Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing 100142, China.
⁷⁷ State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an 710032, China.
⁷⁸ Department of Oncology, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing 210029, China.
⁷⁹ Department of General Surgery, Huadong Hospital Affiliated to Fudan University, Shanghai 200040, China.
⁸⁰ Department of Oncology and Hematology, China-Japan Union Hospital of Jilin University, Changchun 130033, China.
⁸¹ Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, China.
⁸² Department of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.
⁸³ Department of Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang 453000, China.
⁸⁴ Department of Oncology, The Third People's Hospital of Zhengzhou, Zhengzhou 450000, China.
⁸⁵ Department of Biotherapy, State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, China.
⁸⁶ Department of Oncology, the Third Xiangya Hospital, Central South University, Changsha 410013, China.
⁸⁷ Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.
⁸⁸ Department of Cell Biology, College of Medicine, Jiaxing University, Jiaxing 314001, China.
⁸⁹ Department of Medical, Shanghai OrigiMed Co, Ltd, Shanghai 201114, China.
⁹⁰ Department of Medical, Menarini Silicon Biosystems SpA, Shanghai 200333, China.
⁹¹ Department of Medical, Geneplus-Beijing, Beijing 102200, China.
⁹² Department of Oncology, Baotou Cancer Hospital, Baotou 014000, China.
⁹³ Department of Thoracic Disease Diagnosis and Treatment Center, Zhejiang Rongjun Hospital, The Third Affiliated Hospital of Jiaxing University, Jiaxing 314000, China.
⁹⁴ Department of Oncology, Lishui Municipal Central Hospital, Lishui 323000, China.
⁹⁵ Department of Interventional Pulmonary Diseases, Anhui Chest Hospital, Hefei 230011, China.
⁹⁶ Department of Medical Oncology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250012, China.
⁹⁷ Department of Medical Oncology, Shanghai Changzheng Hospital, Naval Medical University, Shanghai 200070, China.
⁹⁸ Department of Oncology, Shandong Provincial Third Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250031, China.
⁹⁹ Department of The Comprehensive Cancer Center, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing 210008, China.
¹⁰⁰ Department of Pathology, Shanxi Academy of Medical Sciences, Shanxi Bethune Hospital, Taiyuan 030032, China.
¹⁰¹ Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.
¹⁰² Department of Interventional Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510060, China.
¹⁰³ Department of Respiratory Medicine, Huzhou Hospital, Zhejiang University School of Medicine, Huzhou 313000, China.
¹⁰⁴ Department of Medical Oncology, The Affiliated Hospital of Jiaxing University, Jiaxing 314000, China.
¹⁰⁵ Department of Radiation Oncology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China.
¹⁰⁶ Department of Medical Oncology, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua 321000, China.
¹⁰⁷ Senior Department of Oncology, The 5th Medical Center of PLA General Hospital, Beijing 100071, China.
¹⁰⁸ Department of Pathology, Anhui Provincial Children's Hospital, Hefei 230051, China.
¹⁰⁹ Department of Radiation Oncology, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, China.
¹¹⁰ Department of Respiratory Medicine, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing 210002, China.
¹¹¹ Department of Clinical Oncology, The 901 Hospital of Joint Logistics Support Force of People Liberation Army, Hefei 230031, China.
¹¹² Department of Thoracic Surgery, Chuxiong Yi Autonomous Prefecture People's Hospital, Chuxiong 675000, China.
¹¹³ Department of Respiratory Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
¹¹⁴ Department of Oncology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310000, China.
¹¹⁵ Department of Oncology, The Second Affiliated Hospital of Guilin Medical University, Guilin 541199, China.
¹¹⁶ International Cooperative Laboratory of Traditional Chinese Medicine Modernization and Innovative Drug Discovery of Chinese Ministry of Education (MOE), Guangzhou City Key Laboratory of Precision Chemical Drug Development, School of Pharmacy, Jinan University, Guangzhou 510632, China.
¹¹⁷ National Health Commission (NHC) Key Laboratory of Nuclear Medicine, Jiangsu Key Laboratory of Molecular Nuclear Medicine, Jiangsu Institute of Nuclear Medicine, Wuxi 214063, China.
¹¹⁸ Department of Radiopharmaceuticals, School of Pharmacy, Nanjing Medical University, Nanjing 210000, China.
¹¹⁹ Department of Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou 450008, China.
¹²⁰ Department of Bone and Soft-tissue Surgery, Chinese Academy of Sciences University Cancer Hospital (Zhejiang Cancer Hospital), Hangzhou 310022, China.
¹²¹ Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Pathology, Peking University Cancer Hospital & Institute, Beijing 100142, China.
¹²² Department of Oncology, The Cancer Hospital of Qinghai Province, Xining 810001, China.
¹²³ Institute of Respiratory Diseases, Xinqiao Hospital, Third Military Medical University, Chongqing 400037, China.
¹²⁴ Department of Pathology, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, China.
¹²⁵ Department of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou 310016, China.
¹²⁶ Department of Thoracic Surgery, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, China.
¹²⁷ Department of Oncology, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou Cancer Hospital, Cancer Center, Westlake University School of Medicine, Hangzhou 310006, China.
¹²⁸ Department of Breast Cancer and Urological Medical Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
¹²⁹ Department of Clinical Pathology, The First Affiliated Hospital of Jinan University, Guangzhou 510630, China.
¹³⁰ Senior Department of Pathology, the 7th Medical Center of PLA General Hospital, Beijing 100700, China.

^# Contributed equally.

PMID: 41704094
PMCID: PMC12980037
DOI: 10.20892/j.issn.2095-3941.2025.0351

Abstract

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.

Keywords: Biomarkers; targeted panel sequencing; tumor immunotherapy; tumor mutational burden; whole-exome sequencing.

PubMed Disclaimer

Conflict of interest statement

No potential conflicts of interest are disclosed.

Figures

**Figure 1**
Flowchart of TMB testing, including sample preparation, quality control standards for sequencing data, TMB analysis principles, and key factors for TMB result reporting.

See this image and copyright information in PMC

References

1. Lawrence MS, Stojanov P, Polak P, Kryukov GV, Cibulskis K, Sivachenko A, et al. Mutational heterogeneity in cancer and the search for new cancer-associated genes. Nature. 2013;499(7457):214–8. - PMC - PubMed
1. Rizvi NA, Hellmann MD, Snyder A, Kvistborg P, Makarov V, Havel JJ, et al. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science. 2015;348(6230):124–8. - PMC - PubMed
1. Chalmers ZR, Connelly CF, Fabrizio D, Gay L, Ali SM, Ennis R, et al. Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden. Genome Med. 2017;9(1):34. - PMC - PubMed
1. Xu C, Hao Y, Wang D, Zhang S, Wang W, Wang Q, et al. ECLUNG consensus/guidelines development principles and methods (2024 edition) Intelligent Pharmacy. 2025;3(2):141–2.
1. Vega DM, Yee LM, McShane LM, Williams PM, Chen L, Vilimas T, et al. Aligning tumor mutational burden (TMB) quantification across diagnostic platforms: phase II of the Friends of Cancer Research TMB Harmonization Project. Ann Oncol. 2021;32(12):1626–36. - PubMed

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Expert consensus on the detection and clinical application of tumor mutational burden

Affiliations

Expert consensus on the detection and clinical application of tumor mutational burden

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical