Clinical Advancement of ctDNA Liquid Biopsy Technology

This clinical trial (NCT04566432) validated the clinical utility of circulating tumor DNA (ctDNA)-based liquid biopsy in patients with non-small cell lung cancer (NSCLC), presenting a new paradigm for the precision diagnostics market. Traditional tissue biopsies are invasive and pose a significant physical burden on patients, but this study opens the door to real-time tracking of the genetic profile of cancer through blood analysis. Geneplus-Beijing Co. Ltd., which led this research, focused on capturing trace amounts of tumor-derived genetic material in the blood to detect disease progression early. This maximizes patient convenience and allows for quantitative assessment of treatment response, contributing to improved personalized treatment outcomes.

Tracking Clonal Evolution to Overcome Immune Checkpoint Inhibitor Resistance

Pembrolizumab and other immune checkpoint inhibitors (ICIs) have become a mainstay in lung cancer treatment, but the biggest challenge is drug resistance that develops during treatment. Cancer cells undergo clonal evolution, inducing genetic mutations to survive under treatment pressure. This study successfully captured the dynamic changes of genetic mutations through longitudinal blood analysis of patients receiving immune checkpoint inhibitors. This allows for early detection and management of resistance clones at a genetic level, even before the cancer shows signs of recurrence in imaging.

Geneplus's Differentiated Multi-Gene Panel Technology

This clinical trial actively utilized Geneplus's core technology, a multi-gene panel test that simultaneously analyzes 1021 tumor-related genes. This panel can precisely decode a wide range of genomic profiles, including single nucleotide variants (SNVs) and insertions/deletions (Indels), as well as copy number variations (CNVs) and fusion genes. In particular, it can simultaneously measure tumor mutational burden (TMB) and microsatellite instability (MSI), both important indicators for immunotherapy, demonstrating excellent competitiveness in the companion diagnostics (CDx) field. Compared to products such as Guardant360 from Guardant Health, the number of covered genes is overwhelmingly higher, making it advantageous for analyzing complex cancer genomes in a comprehensive manner.

Growth Driver for the Precision Medicine Market for Non-Small Cell Lung Cancer

The global NSCLC treatment market is expected to reach approximately USD 20 billion to 31 billion by 2026, with an annual growth rate of around 10%, making the growth of companion diagnostics essential. In particular, with immune-oncology therapies becoming the standard of care for patients with stage III or later NSCLC, the demand for appropriate patient selection and drug response monitoring is rapidly increasing. The combination of liquid biopsy and immune-oncology therapy is a useful tool that can prevent unnecessary prescriptions of expensive cancer drugs and guide patients who do not respond to treatment to switch to other targeted therapies.

Commercialization Roadmap and Future Changes in the Clinical Setting

With the completion of the study, the scientific basis for Geneplus's liquid biopsy technology to be integrated into the standard treatment process in the clinical setting has been further strengthened. In the future, through the acquisition of approval from the National Medical Products Administration (NMPA) and the acceleration of clinical entry, the company plans to accelerate its entry into the companion diagnostics and cancer recurrence monitoring markets, primarily in the Asia-Pacific (APAC) region. If partnerships with multinational pharmaceutical companies for joint clinical trials for new cancer drugs are expanded, additional financial gains, such as milestone payments, can also be expected.