echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Digestive System Information > The 2021 edition of the "Chinese Expert Consensus on High-throughput Sequencing for Molecular Detection of Colorectal Cancer" is released. What hardcores should I know?

    The 2021 edition of the "Chinese Expert Consensus on High-throughput Sequencing for Molecular Detection of Colorectal Cancer" is released. What hardcores should I know?

    • Last Update: 2021-05-09
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Heavy release: Recently, the "Journal of Clinical Oncology" released the 2021 version of the "Consensus of Chinese Experts on High-throughput Sequencing for Molecular Detection of Colorectal Cancer" (hereinafter referred to as the "Consensus").
    The "Consensus" was targeted by the Chinese Anti-Cancer Association Initiated by the professional committee, under the guidance of more than 20 experts in clinical, pathological and other fields, and the participation and support of more than 10 head diagnosis companies in the industry, combined with the actual diagnosis and treatment needs of colorectal cancer, the second-generation Qualcomm Provide guidance from the clinical perspective and laboratory process quality control perspective of next generation sequencing (NGS) testing.
    After one year of repeated discussions, it was officially published in the Journal of Clinical Oncology, Volume 26, Issue 3, March 2021 .

    What is the background of the launch of the 2021 version of Consensus? What is the significance, and what are the highlights? 2021 edition of "Chinese Expert Consensus on High-throughput Sequencing for Molecular Detection of Colorectal Cancer".
    Journal of Clinical Oncology.
    2021;26(3):253-264 NGS track is hot, and the quality control process urgently needs to regulate the incidence of colorectal cancer in my country Shows an upward trend year by year.
    Data from the International Agency for Research on Cancer (IARC) of the World Health Organization show that the number of new cases of colorectal cancer in my country in 2020 will be 560,000, and the number of deaths from colorectal cancer will reach 29.
    Ten thousand cases [1].

    About 25% of patients with colorectal cancer have had distant metastases at the time of diagnosis.

    In addition, 30% of patients have metastases during treatment, and the prognosis of patients with metastatic colorectal cancer is poor, and the 5-year survival rate has dropped to 11.
    7% [2].

    In recent years, with the advancement of diagnosis and treatment and the emergence of targeted drugs and immunotherapy, more and more colorectal cancer patients have passed the five-year survival period and achieved longer survival benefits.

    Among patients with metastatic colorectal cancer, patients with wild-type RAS gene can achieve survival benefits through specific targeted therapy drugs (such as anti-EGFR monoclonal antibodies) and have a good prognosis.

    Molecular marker detection is a prerequisite for screening people who benefit from targeted therapy.
    With the rapid development of detection technology in recent years, NGS can quickly generate very large DNA molecules due to the ability to sequence hundreds of thousands to millions of DNA molecules at a time.
    Genomics, epigenomics, and transcriptomics research data sets undoubtedly provide greater possibilities for accurate diagnosis.

    The comprehensive advantages of NGS detection in terms of throughput, cost and efficiency have shown more and more broad application prospects in the detection of tumor gene mutations.

    With the development of precision diagnosis and treatment of colorectal cancer, the NGS platform in the hospital has increased significantly.
    There are a large number of third-party laboratories that can perform NGS testing.
    The combination of NGS instruments and reagents is diversified.
    Each platform adopts different performance parameters, which imposes requirements on testing quality management.
    There are many challenges.

    The NGS testing technology process is complex and requires high laboratory environmental conditions, personnel capabilities and quality management.
    Problems in any link will affect the accuracy of the test results, and then affect clinical decision-making [3].

    In order to ensure the accuracy and standardization of clinical diagnosis and treatment, it is initiated by clinicians in combination with the actual diagnosis and treatment needs of colorectal cancer, under the guidance of pathology and laboratory experts, and the participation of head diagnosis companies in the industry, respectively, from the clinical perspective and laboratory of colorectal cancer NGS detection.
    From the perspective of process quality control, a consensus of Chinese experts was jointly drafted to guide the standardized application of NGS detection technology in the diagnosis and treatment of colorectal cancer. From the clinical and laboratory, based on the establishment of industry norms and standards, the six highlights of the "Consensus" are first to look at in order to solve the current problems in clinical applications and improve the understanding and application of NGS for colorectal cancer molecular detection by practitioners in related industries.
    The release of the 2021 version of the "Consensus" proposes for the first time clinical and laboratory specifications, from the clinical significance of colorectal cancer biomarker testing, to sample processing and transportation, report interpretation and standard templates, and the requirements for NGS laboratory construction.
    In order to guide the standardized application of NGS detection technology in the diagnosis and treatment of colorectal cancer, it is reflected in: 1) Clinicians standardize sampling and more accurate report interpretation; 2) NGS industry is better regulated to ensure the accuracy of the detection process and report.
    Colorectal cancer targeted therapy and immunotherapy provide a more standard reference basis.

    Which highlights of the "Consensus" are worth paying attention to? Highlight 1: Starting from the clinical application of colorectal cancer NGS detection and laboratory process quality control, experts from the entire industry chain jointly draft specifications and standards; Highlight 2: clarify the "necessary" and "optional" results Relevant biomarkers for rectal cancer diagnosis and treatment; Highlight 3: Collected TMB kit information provided by some NGS companies currently on the market; Highlight 4: Make clear recommendations for molecular testing content at different disease stages; Highlight 5: Provide NGS test reports Template; Highlight 6: Clarified reference documents for NGS laboratory construction.

    With the rapid development of NGS, strengthening industry supervision has become an international consensus.
    With the rapid development of NGS technology, the continuous changes in industry regulations have also brought various challenges to practical applications.
    Regulatory agencies around the world are actively formulating regulations to promote the healthy development of the genetic testing industry.

    In the United States, clinical laboratories are supervised by several governing bodies.

    For example, the American College of Pathologists (CAP) develops best practice guidelines for clinical laboratories.

    With the development of molecular technology, organizations such as the American Medical Genetics and Genomics (ACMG) and the Association of Molecular Pathology (AMP) have also entered the field.

    In 2015, ACMG and AMP issued a joint guideline on the interpretation of clinical diagnostic genetic testing.

    These guidelines strongly recommend that clinical molecular genetic testing should be performed in a certified laboratory and be specific to include who can interpret the results.

    In my country, genetic testing has become a prerequisite for accurate clinical diagnosis and treatment of tumors, but the consensus on the application of NGS is limited.

    In 2017, my country officially published the Chinese version of "ACMG Classification Standards and Guidelines for Genetic Variation", which has been officially authorized by ACMG.

    Since then, consensus on the application of NGS technology in colorectal cancer, hematological tumors, lung cancer and other diseases has been introduced one after another.

    Today, the 2021 version of the "Chinese Expert Consensus on High-throughput Sequencing for Colorectal Cancer Molecular Detection" has been released.
    It is foreseeable that in the future, as the genetic testing industry standards and specifications become more and more perfect, it will further promote the precise diagnosis and treatment of colorectal cancer and NGS technology.
    Application of the norm.

    Written at the end, NGS has obvious throughput advantages and the advantage of discovering unknown gene mutations, but there are also various challenges in use including detection technology, data management, analysis and reporting, interpretation and clinical consultation.

    The official release of the 2021 version of the "Consensus" will definitely play an important role in promoting the standardization of NGS, providing clinicians and industry testers with standardized and valuable guidance.
    In addition to assisting clinicians to provide reference for precise treatment decisions, it also To achieve standardization and standardization of testing and quality control in clinical laboratories.

    On April 21, 2021, the "Consensus" will also be released online through relevant media.
    A number of experts have respectively addressed: Professor Xu Ruihua, Dean of Sun Yat-sen University Cancer Hospital: Professor Xu Ruihua, Director, Dean, and Director of Sun Yat-sen University Cancer Center Director of the State Key Laboratory of Oncology in South China Director of the Provincial and Ministry Co-constructed Collaborative Innovation Center for Cancer Medicine Director of the National Center for New Drugs (Anti-tumor Drugs) Clinical Trials Member of the Ministry of Education, Science and Technology Committee of the Department of Biology and Medicine Vice Chairman of the Chinese Anti-Cancer Association Vice Chairman of the Chinese Society of Clinical Oncology Chairman, Chinese Medical Biotechnology Association Vice Chairman, Guangdong Anti-Cancer Association Chairman, China Anti-Cancer Association Targeted Therapy Professional Committee Chairman, Chinese Society of Clinical Oncology, Gastric Cancer Expert Committee Chairman, Chinese Society of Clinical Oncology, Colon Cancer Expert Committee, Designated Chairperson The rapid development of precision diagnosis and treatment of rectal cancer has now entered the era of molecular pathology.
    Under this trend, precision detection represented by NGS technology has gradually moved from scientific research laboratories to clinical applications.

    The information obtained from genetic testing of patients with metastatic colorectal cancer will have a very important impact on treatment and prognosis.

    The implementation of the "Consensus" brings another step forward in the accurate detection of colorectal cancer.

    We hope that through the joint efforts of various hospitals, clinical units, and precision diagnosis companies, we will promote the standardization of genetic testing and reporting.
    We also hope that through our efforts, genetic testing will be included in medical insurance as soon as possible in the future to reduce the burden on patients.

    Professor Liang Zhiyong, Director of the Department of Pathology, Peking Union Medical College Hospital: Professor Liang Zhiyong, Chief Physician, Director of the Department of Pathology, Peking Union Medical College Hospital, PhD supervisor, Chairman of the Pathology Branch of the Chinese Medical Association, Director of the Chinese Medical Care International Exchange Promotion Association, Director of the Pathology Professional Committee, Chinese Medical Association Pathology The leader of the Molecular Pathology Quality Control Group of the Academic Branch and the Pathology Quality Control Center of the National Health Commission, the editor-in-chief of the Journal of Diagnostic Pathology, the deputy editor-in-chief of the Chinese Journal of Pathology.
    The quality control of molecular pathology in China is developing, and the molecular pathology testing standards for colorectal cancer are constantly updated.

    However, the popularity of genetic testing in China, the detection rate of colorectal cancer biomarkers, especially the RAS genetic testing rate, and the standardization of testing procedures still lag behind those of European and American countries.
    The testing capabilities of primary hospitals also need to be improved.
    The molecular testing platforms of many hospitals need to be improved urgently.

    I believe that the release of this "consensus" will also bring instructive significance to clinicians and pathologists, and make genetic testing more accurate and standardized in clinical practice, which will benefit more colorectal cancer patients.

    Special thanks to the writing of the "Consensus" from preparation to release, for the guidance of more than 20 clinical, pathological and laboratory experts and the support of more than ten companies for accurate diagnosis of the head, including: expert team members (ranked by phonetic alphabet of surnames): Bai Wei (Shanxi Cancer Hospital), Guo Zengqing (Fujian Cancer Hospital), Hu Xiaohua (The First Affiliated Hospital of Guangxi Medical University), Li Yuhong (Sun Yat-sen University Cancer Hospital), Liu Jing (Shanghai Ruijin Hospital), Qiu Meng (Sichuan University, West China) Hospital), Wang Feng (Sun Yat-sen University Tumor Hospital), Xu Ruihua (Sun Yat-sen University Tumor Hospital), Ying Jieer (University Tumor Hospital, Chinese Academy of Sciences), Zhang Yanqiao (Harbin Medical University Tumor Hospital), Zeng Shan (Central South University Xiangya Members of the writing group of the hospital (ranked by phonetic surname): Chen Gong (Sun Yat-sen University Cancer Hospital), Liang Zhiyong (Chinese Academy of Medical Sciences Peking Union Medical College Hospital), Liang Li (Southern Medical University Southern Hospital), Shao Jianyong (Sun Yat-sen University Cancer Hospital) ), Sudan (University of Chinese Academy of Sciences Cancer Hospital), Tang Yuan (Sichuan University West China Hospital), Wang Feng (Sun Yat-sen University Cancer Hospital), Wan Desen (Sun Yat-sen University Cancer Hospital), Wu Huanwen (Chinese Academy of Medical Sciences Peking Union Medical College Hospital) , Xue Weicheng (Peking University Cancer Hospital), Xu Ruihua (Sun Yat-sen University Cancer Hospital), Ying Jianming (Chinese Academy of Medical Sciences Cancer Hospital), Zhang Bo (Peking University Third Hospital), Zhou Weixun (Chinese Academy of Medical Sciences Peking Union Medical College Hospital), Zhou Xiaoyan (Fudan University-affiliated cancer hospital) diagnostic companies (in alphabetical order of company names): Guangzhou Golden Field Medical Laboratory Group Co.
    , Ltd.
    , Guangzhou Burning Rock Medical Laboratory Co.
    , Ltd.
    , Jiangsu Simcere Medical Diagnosis Co.
    , Ltd.
    , Nanjing Shihe Gene Co.
    , Ltd.
    , Qiuzhen Medical Technology (Beijing) Co.
    , Ltd.
    , Shanghai Kunyuan Biotechnology Co.
    , Ltd.
    , Shanghai Reon Gene Technology Co.
    , Ltd.
    , Shanghai Silidi Biotechnology Co.
    , Ltd.
    , Wuxi Zhenhe Biotechnology Co.
    , Ltd.
    , Xiamen Aide Biomedicine Technology Co.
    , Ltd.
    , Immena (China) Scientific Equipment Co.
    , Ltd.
    , Zhiben Medical Technology (Shanghai) Co.
    , Ltd. References[1] International Agency for Research on Cancer.
    Latest global cancer data: Cancer burden rises to 19.
    3 million new cases and 10.
    0 million cancer deaths in 2020[EB/OL].
    [2021-01-10].
    https:// www.
    iarc.
    fr/faq/latest-global-cancer-data-2020-qa/.
    [2] Siegel R, DeSantis C, Virgo K, et al.
    Cancer treatment and survivorship statistics, 2012.
    CA Cancer J Clin 2012; 62:220-41.
    [3] Beijing Clinical Laboratory Center, Laboratory Medicine Branch of Beijing Medical Association, Department of Laboratory Diagnostics, Capital Medical University, etc.
    Beijing Expert Consensus on Standardization of High-throughput Sequencing Technology Clinical Detection (First Edition General Part) [J].
    Chinese Medical Journal, 2019,99(43): 3393-3397.
     
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.