Diagnostic study demonstrates high-sensitivity tumor mutation detection in plasma from colorectal cancer patients, highlighting a viable microfluidic liquid biopsy platform.
Key Points
To develop and evaluate an integrated microfluidic platform capable of capturing tumor-derived extracellular vesicles and identifying low-abundance DNA mutations with single-nucleotide resolution.
Engineered the MIRACLE platform, combining anti-EpCAM-functionalized magnetic beads inside a herringbone-structured microfluidic chip with a 7-plex single base extension assay and MALDI-TOF mass spectrometry.
Assessed analytical performance and detection limits across wild-type extracellular vesicle backgrounds.
Validated the clinical detection of key mutations using plasma samples from 26 colorectal cancer patients.
Achieved an extracellular vesicle capture efficiency exceeding 98% and established a mutation detection limit of 0.05% tumor-derived vesicles in background wild-type vesicles.
Demonstrated 96.2% diagnostic accuracy and 93.3% sensitivity in clinical plasma validation (N=26), correctly identifying key mutations including G12V, G13D, and G12D.