Diagnostic Performance of a Multiplex Circulating Tumor DNA Assay for Lung Cancer Detection

Lung cancer remains the leading cause of cancer-related death worldwide, largely due to late-stage diagnosis. Although low-dose computed tomography (LDCT) screening can reduce mortality, it is limited by high false-positive rates, radiation exposure, and low adherence. Thus, there is an urgent need for precise, accessible, and non-invasive diagnostic alternatives. This study evaluated the diagnostic accuracy of a novel multiplexed digital droplet polymerase chain reaction (ddPCR) assay targeting hypermethylated ctDNA markers (HOXA9, OTX1, MCIDAS, SP9, and TFAP2B) in plasma for lung cancer detection.