IVD行业动态 News of IVD

#前沿/Article

1. 3月3日，复旦大学团队于Gastroenterology绘制出基于中国人群的结直肠癌基因组变异特征图谱，并鉴定出其中可精准预测结直肠癌靶向治疗和免疫治疗疗效的基因组标志物。

1. The terms of Ye Xu integrated analysis provides insights into CRC prognostic stratification, drug response, and personalized genomics-guided targeted and immunotherapies (March 3, Gastroenterology).

2. 3月23日，贝勒大学医学院团队于Nat Rev Clin Oncol深度剖析了全球范围内的胃癌流行病学趋势、主要危险因素及其变化情况，并就此提出了未来胃癌防治的几大要点。

2. The terms of Hashem B El-Serag highlight the latest trends in incidence and mortality using an evidence-based approach, including clinical and public health inference, on the basis of the quality of the evidence available, and highlight burning questions as well as gaps in knowledge and public health practice that need to be addressed to reduce gastric cancer burden worldwide. (March 23, Nat Rev Clin Oncol).

#国内/China

1. 近日，华大基因发布了首份《2023年全球结直肠癌认知现状报告》，旨在揭示结直肠癌防控工作所面临的挑战。

1. Recently, BGI released the first "Global Status Report on Colorectal Cancer Awareness in 2023", which aims to reveal the challenges faced by the prevention and control of colorectal cancer.

2. 5月4日，国家药监局召开2022年度疫苗监管质量管理体系管理评审会议，总结体系建设运行情况，评价体系的适宜性、充分性和有效性，安排部署下一步重点工作。

2. May 4, the NMPA held the 2022 Vaccine Regulatory Quality Management System Management Review Meeting to summarize the construction and operation of the system, evaluate the suitability, adequacy and effectiveness of the system, and arrange the deployment of key tasks for the next step.

3. 5月5日，卡尤迪生物科技宜兴有限公司首次注册获批新型冠状病毒2019-nCoV和甲型乙型流感病毒核酸检测试剂盒（荧光PCR法）（国械注准20233400584）。

3. May 5, Coyote Bioscience registered and approved the FlashDetect™ LyocartD SARS-CoV-2&Flu A&Flu B Assay for the first time (NO. 20233400584).

4. 5月5日，科美诊断首次注册获批单纯疱疹病毒1+2型IgG抗体（HSV1+2 IgG）检测试剂盒（光激化学发光法，国械注准20233400585）。

4. May 5, ChemClin Diagnositics registered and approved the HSV1+2 IgG antibody detection kit for the first time (Chemiluminescence method, NO. 20233400585).

5. 5月5日，深圳迈瑞首次注册获批乙型肝炎病毒核心抗体测定试剂盒（化学发光免疫分析法国械注准20233400582）。

5. May 5, Mindray registered and approved the Hepatitis B virus core antibody assay kit for the first time (Chemiluminescent immunoassay, NO. 20233400582).

#国际/International

1. 5月2日，意大利卫生部更新“2020-2025 年国家预防计划 (PNP)”研讨会。

1. May 2, Workshop proceedings National prevention plan 2020-2025: Schools that promote health (Italy).

2. 5月3日，法国CNR Santé 全体会议重点介绍3个创新现场解决方案，包括Medical Presence 64 是一个促进在该地区安装全科医生（在其专业和个人项目中）的团体。

2. May 3, CNR Santé plenary (France) Highlighting 3 examples of innovative field solutions, include Medical Presence 64 is a collective that facilitates the installation of general practitioners (in their professional and personal projects) in the territory.

3. 5月3日，美国FDA 批准首个呼吸道合胞病毒 (RSV) 疫苗, Arexvy 批准用于60岁及以上的个人。

3. May 3, the U.S. FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine, Arexvy Approved for Individuals 60 Years of Age and Older.

4. 5月3日，WHO发文称：本地合作是全球实现与健康相关的可持续发展目标的关键。

4. May 3, WHO published: Collaborating locally is key for progress globally towards health-related SDGs.

5. 5月3日，韩国保健福祉部发文称：在韩国接受治疗的国际患者人数从 2021 年的 146,000 人增加到 2022 年的 248,000 人，增长了 70.1%。

5. May 3, The Ministry of Health and Welfare (Minister Cho, KyooHong) said the number of international patients treated in Korea rose by 70.1% from 146,000 in 2021 to 248,000 in 2022.