According to recent monitoring data, China recorded 1,060,600 new cases of lung cancer in 2022, accounting for 22% of all malignant tumors. Lung cancer-related deaths reached 733,300, representing 28.5% of all cancer fatalities. The incidence and mortality rates were 75.13 per 100,000 and 51.94 per 100,000, respectively, with an overall upward trend. Despite recent improvements, the five-year survival rate for lung cancer patients in China remains relatively low. However, early diagnosis and treatment can significantly enhance this survival rate.

The primary risk factors for lung cancer include tobacco exposure, air pollution, occupational hazards, chronic obstructive pulmonary disease (COPD), and a family history of lung cancer.

Recent advancements in precision diagnosis and treatments for intermediate and advanced lung cancer have improved patient outcomes, though lung cancer continues to have the highest incidence and mortality rates among malignant tumors. Early detection and appropriate intervention are crucial for improving overall prognosis. The integration of multi-omics technologies—such as imaging genomics, interventional diagnostics, genomics, proteomics, big data, and artificial intelligence—into early lung cancer diagnosis has shown significant progress and plays a key role in improving outcomes.

Histological Techniques and Biomarkers

Modern histological techniques, including genomics, epigenomics, transcriptomics, proteomics, metabolomics, microbiomics, and exosome analysis, have been instrumental in developing biomarkers. These biomarkers are valuable not only for screening and early diagnosis but also for guiding treatment decisions, monitoring disease progression, assessing and predicting treatment efficacy, and forecasting patient prognosis.

Several studies have indicated that autoantibodies can be detected months or even years before a cancer diagnosis is made through imaging. These autoantibodies are an independent risk factor for lung cancer, aiding in identifying high-risk populations.

DNA methylation has emerged as a significant marker for early cancer screening and is widely used both domestically and internationally.

Liquid biopsy, particularly plasma testing, has rapidly advanced in recent years. Its non-invasive, real-time capabilities, coupled with its ability to address tumor heterogeneity, have made it a popular choice in tumor screening, diagnosis, and treatment monitoring. Among the various techniques, circulating tumor DNA (ctDNA) testing is the most widely used in clinical practice, especially in lung cancer, where it plays a critical role in precision treatment and patient management.

Recent Industry Developments

In July 2024, Riken Genesis Co., Ltd., Amoy Diagnostics, and Precision Medicine Asia Co., Ltd. announced that the Japanese Ministry of Health, Labour, and Welfare had approved the AmoyDx® Pan Lung Cancer PCR Panel as a companion diagnostic for Haiyitan® (gumarontinib), a product of Haihe Biopharma K.K. Haiyitan®, in 50 mg tablet form, was approved in June 2024 for patients with unresectable advanced or recurrent non-small cell lung cancer with MET exon 14 (METex14) skipping mutations.

In June 2024, Roche announced that its Ventana PD-L1 (SP263) assay received a CE-IVDR label expansion for use as a companion diagnostic with Regeneron's Libtayo (cemiplimab) in combination with platinum-based doublet chemotherapy in lung cancer patients. 

In May 2024, Guardant Health announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). The certification from TÜV SÜD Product Service is for tumor mutation profiling in patients with any solid cancerous tumor and for companion diagnostic indications to identify patients who may benefit from certain targeted therapies for advanced non-small cell lung cancer and breast cancer.