2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.06B.10 Clinical Feasibility of Multiplex Digital PCR for Major Mutation Detection in NSCLC Patients: The Droplex NSCLC Panel Test

EP.06B.10 Clinical Feasibility of Multiplex Digital PCR for Major Mutation Detection in NSCLC Patients: The Droplex NSCLC Panel Test

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The study evaluates the clinical feasibility of the Droplex NSCLC Panel Test, a multiplex digital PCR-based test kit, for detecting major mutations in non-small cell lung cancer (NSCLC) patients. This novel test overcomes the limitations of next-generation sequencing (NGS), particularly its long turnaround time, extensive DNA/RNA input requirements, and need for specialized expertise. Droplex offers a simplified workflow, high sensitivity and specificity, minimal sample needs, and a one-day turnaround time at lower costs than NGS, making it a promising option for mutation detection.<br /><br />The Droplex NSCLC Panel Test can identify 180 key mutations across 11 genes significant in NSCLC (such as EGFR, ALK, ROS1, BRAF, and others) using DNA and RNA from FFPE (formalin-fixed paraffin-embedded) tissue samples. The test utilizes oligo mixtures for detecting mutations in four key genes and fusions in seven others. By using a single sample for DNA and RNA extraction and employing a six-channel digital PCR system, the analytical performance of the test was validated with high concordance compared to existing molecular testing methods.<br /><br />Comparatively, Droplex offers several advantages over NGS, including higher sensitivity, straightforward data interpretation, and absolute mutation load quantification. It achieves these with a much faster one-day turnaround and reduced structural complexities, detecting specific genetic alterations at lower costs and smaller sample quantities.<br /><br />Results from a blind test of 100 samples demonstrated a 94% concordance with existing diagnostic results. With its high accuracy and cost-effectiveness, the Droplex NSCLC Panel Test emerges as a practical diagnostic tool for NSCLC, supporting its promise as a first-line diagnostic resource. The study received backing from the National Research Foundation of Korea, indicating its importance within current diagnostic innovation efforts.

Asset Subtitle

Kyung A Kim

Meta Tag

Speaker Kyung A Kim

Topic Pathology and Biomarkers

Keywords

Droplex NSCLC Panel Test

digital PCR

non-small cell lung cancer

mutation detection

EGFR

ALK

ROS1

BRAF

FFPE tissue samples

National Research Foundation of Korea