A novel reagent kit for early lung cancer detection, developed by researchers from the Hangzhou Institute of Medicine under the Chinese Academy of Sciences, has received Class III medical device registration from China's National Medical Products Administration. The kit is expected to improve early diagnosis rates of lung cancer.

Lung cancer remains the most common and deadliest cancer in China. Most early-stage lung cancers present as small pulmonary nodules. An estimated 150 million people in China have pulmonary nodules, with over 95 percent being benign, according to public data. 

Current diagnostic methods, including CT imaging, sputum cytology, and conventional tumor antigen markers, either lack sensitivity or are unsuitable for early screening.  

While low-dose spiral CT has been widely used for lung cancer screening in recent years, it often cannot distinguish between benign and malignant nodules, requiring patients to undergo regular follow-ups. Compliance with such follow-up monitoring, however, remains low.

"Determining whether a pulmonary nodule is benign or malignant is key to solving the challenge of early lung cancer diagnosis and reducing lung cancer mortality," said Hu Hai, a researcher at the Hangzhou Institute of Medicine and the project's lead scientist.  

Hu explained that since 2016, the research team has focused on detecting tumor autoantibodies, antibodies that the immune system produces when detecting early cancer cells, to capture early "molecular signals" of lung cancer. This approach can provide early warning even when cancer cells are extremely few and the condition is asymptomatic, making it suitable for early screening.

To develop the test, researchers screened hundreds of cancer-related proteins using advanced biotechnology and AI, eventually identifying a panel of 13 biomarkers that together indicate early lung cancer. Eight of these markers are entirely new discoveries.

The kit has been tested at several major hospitals in China, including Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and Beijing Chest Hospital affiliated to Capital Medical University.

The trials involved 1,463 patients with pulmonary nodules, including 794 confirmed lung cancer cases, of which 58.19 percent were early-stage. Results showed a sensitivity of over 65 percent for early lung cancer detection, with accuracy superior to traditional tumor markers.  

"The kit can complement imaging diagnostics and may be widely adopted in primary hospitals and physical examination centers to improve screening coverage among high-risk populations," Hu said.