【新华社】我国新型肺癌早诊试剂盒获批上市

Core Viewpoint - The research team from the Chinese Academy of Sciences in Hangzhou has developed a test kit for lung cancer-related antibodies, which has received Class III medical device registration from the National Medical Products Administration, potentially improving early diagnosis rates for lung cancer [2]. Group 1 - The test kit utilizes low-dose spiral CT, which is commonly used for lung cancer screening but struggles to differentiate between benign and malignant nodules, leading to low patient follow-up compliance [2]. - The project has focused on tumor autoantibody detection technology since 2016, aiming to capture early molecular signals of lung cancer, providing alerts even when cancer cell counts are very low [2][4]. - The test kit has been tested in several hospitals, including Huazhong University of Science and Technology and Sun Yat-sen University, involving 1,463 patients with lung nodules, of which 794 were lung cancer cases, with early lung cancer samples accounting for 58.19% [4]. Group 2 - The team has developed over 400 key proteins related to early lung cancer using a million-level cancer tissue library and high-throughput screening technology, ultimately identifying 13 optimal diagnostic markers, 8 of which are new combinations [4]. - The sensitivity for detecting early lung cancer exceeds 65%, and its accuracy is better than traditional tumor markers, complementing imaging diagnostics [4]. - The technology is expected to be promoted in grassroots hospitals and health check-up institutions, enhancing screening coverage for high-risk populations and supporting the "Healthy China 2030" cancer early screening strategy [4].