Electrochemical Detection of BRAF V600E Mutation in a Liquid Biopsy Format: LAMPing the Way to an Improved Diagnostics and Treatment

Abstract The BRAF V600E substitution, predominantly found in melanoma and metastatic colorectal cancer (mCRC), is associated with aggressive traits and poor prognosis. Molecular testing of the BRAF mutational status is crucial for guiding therapeutic decisions, driving the necessity for new rapid diagnostic technologies. Here, a novel LAMP‐based assay is presented for fast and selective amplification of mutated DNA, coupled with simple electrochemical detection on electrode biochips. The assay demonstrated high selectivity across cell lines and in 51 cancer patients, detecting mutations in both tumor tissue DNA and circulating tumor DNA (ctDNA) in serum. Clear discrimination between the mutated and wild‐type sequences is achieved, in perfect agreement with either NGS or ddPCR. The bioassay offers a simple and efficient alternative to traditional PCR methods for point‐of‐care diagnostics, particularly in settings with limited equipment and resources.