Evaluation of a novel saliva‐based epidermal growth factor receptor mutation detection for lung cancer: A pilot study

Abstract

BackgroundThis article describes a pilot study evaluating a novel liquid biopsy system for non‐small cell lung cancer (NSCLC) patients. The electric field‐induced release and measurement (EFIRM) method utilizes an electrochemical biosensor for detecting oncogenic mutations in biofluids.MethodsSaliva and plasma of 17 patients were collected from three cancer centers prior to and after surgical resection. The EFIRM method was then applied to the collected samples to assay for exon 19 deletion and p.L858 mutations. EFIRM results were compared with cobas results of exon 19 deletion and p.L858 mutation detection in cancer tissues.ResultsThe EFIRM method was found to detect exon 19 deletion with an area under the curve (AUC) of 1.0 in both saliva and plasma samples in lung cancer patients. For L858R mutation detection, the AUC of saliva was 1.0, while the AUC of plasma was 0.98. Strong correlations were also found between presurgery and post‐surgery samples for both saliva (0.86 for exon 19 and 0.98 for L858R) and plasma (0.73 for exon 19 and 0.94 for L858R).ConclusionOur study demonstrates the feasibility of utilizing EFIRM to rapidly, non‐invasively, and conveniently detect epidermal growth factor receptor mutations in the saliva of patients with NSCLC, with results corresponding perfectly with the results of cobas tissue genotyping.

A field guide for cancer diagnostics using cell‐free DNA: From principles to practice and clinical applications

“…3 Notably, cfDNA and ctDNA can also be detected in urine of patients with bladder cancer, 4-6 colorectal cancer, 7,8 and was recently reported for patients with non-small cell lung cancer (NSCLC). 9,10 Other biological materials, such as stool, 11,12 saliva, 13 cerebrospinal fluid, 14 and pleural fluid 15 can also serve as sources of ctDNA.…”

Saliva-Exosomics in Cancer: Molecular Characterization of Cancer-Derived Exosomes in Saliva

“…Recently, we developed a novel salivary diagnostics platform EFIRM (electric field-induced release and measurement) that can detect and quantify ctDNA with high sensitivity using electrochemical sensor [50]. We tested the ability of EFIRM to detect tyrosine kinase inhibitor-sensitive EGFR mutations (exon 19 deletion and L858R mutations) directly from saliva and plasma of lung cancer patients [50,59]. A receiver-operating characteristic (ROC) curve analysis demonstrated that EFIRM detected EGFR exon 19 deletion and L858R mutation in saliva with an area under the ROC curve (AUC) of 0.94 and 0.96, respectively, suggesting that saliva-based EGFR mutation detection (SABER) met the clinical requirements.…”

Salivary biomarkers in cancer detection

“…The receiver operating characteristic (ROC) analysis indicated that EFIRM detected the exon 19 deletion with the AUC of 0.94 and the L858R mutation with an AUC of 0.96 [12]. Pu et al used EFIRM to detect exon 19 deletion and L858R mutations in saliva and plasma samples of lung cancer patients [57]. This study resulted in the detection of exon 19 deletion with the AUC of 1.0 in both saliva and plasma samples in lung cancer patients.…”