近日，国家药品监督管理局正式批准了我国首个用于肺结节辅助诊断的体外诊断试剂盒上市。该产品基于高通量测序和人工智能算法，通过检测血液中特定的循环肿瘤DNA（ctDNA）甲基化标志物，对肺结节良恶性进行风险评估，为临床医生提供更精准的决策支持。肺癌是我国发病率和死亡率最高的恶性肿瘤之一，而早期发现肺结节并准确判断其性质，是提高肺癌治愈率的关键。传统影像学检查虽能发现结节，但难以区分良恶性，常导致过度随访或不必要的手术。此次获批的试剂盒填补了国内在肺结节分子辅助诊断领域的空白，具有无创、便捷、高灵敏度等优势。临床试验数据显示，该试剂盒在区分良性与恶性肺结节方面表现出良好的敏感性和特异性，尤其适用于直径小于2厘米的结节人群。未来，该技术有望与低剂量CT等影像手段结合，构建多模态肺癌早筛体系，提升我国肺癌早诊早治水平。
Recently, China’s National Medical Products Administration (NMPA) has officially approved the country’s first in vitro diagnostic kit for auxiliary diagnosis of pulmonary nodules. Leveraging high-throughput sequencing and artificial intelligence algorithms, this test evaluates the risk of malignancy in lung nodules by detecting specific methylation markers of circulating tumor DNA (ctDNA) in blood, offering clinicians more precise decision-making support.Lung cancer remains the leading cause of cancer-related deaths in China. Early detection of pulmonary nodules and accurate differentiation between benign and malignant lesions are critical to improving survival rates. While conventional imaging can identify nodules, it often fails to reliably distinguish their nature, leading to unnecessary follow-ups or surgeries. This newly approved diagnostic kit fills a significant gap in China’s molecular diagnostics landscape for pulmonary nodules, offering a non-invasive, convenient, and highly sensitive solution.Clinical trial data demonstrate that the kit achieves strong sensitivity and specificity in differentiating benign from malignant nodules, particularly in patients with nodules smaller than 2 centimeters. In the future, this technology is expected to be integrated with low-dose CT and other imaging modalities to establish a multimodal early lung cancer screening system, significantly enhancing China’s capacity for early detection and intervention.
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