The emergence of “precision medicine” marks a notable shift in cancer treatment, moving from a tumor type–oriented approach to a more targeted, gene‐oriented approach. Detecting low‐abundance mutant genes in blood is challenging but crucial for personalized treatment plans. Herein, a novel platform combining catalytic hairpin self‐assembly (CHA)‐mediated self‐calibrating surface‐enhanced Raman spectroscopy (SERS) with a high‐throughput Raman system (CCSPS) was designed. This platform enables ultrasensitive and rapid genotype analysis of gene mutations. The development of CCSPS specifically targets EGFR mutations, which serve as crucial therapeutic targets for precision therapy in lung cancer. This system shows excellent sensitivity and selectivity, capable of detecting multiple EGFR mutations (Del‐19, L858R, and T790M) with a detection limit as low as attomolar levels. Additionally, precise genotyping analysis was successfully conducted on 42 clinical samples using the CCSPS, yielding results consistent with those obtained through next‐generation sequencing. These results underscore the efficacy of the CCSPS in noninvasively identifying circulating tumor DNA (ctDNA) mutations, facilitating immediate therapeutic decision making at the bedside. In summary, the CCSPS is a fast, accurate, versatile, and compact testing system capable of precisely screening individuals who stand to benefit from targeted therapy, thus promoting personalized and precise healthcare.

中文翻译：

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通过基于表面增强拉曼光谱的光学传感芯片进行精确基因分型，以指导肺癌的靶向治疗


“精准医疗”的出现标志着癌症治疗的显著转变，从以肿瘤类型为导向的方法转变为更具针对性、以基因为导向的方法。检测血液中的低丰度突变基因具有挑战性，但对于个性化治疗计划至关重要。在此，设计了一个将催化发夹自组装 （CHA） 介导的自校准表面增强拉曼光谱 （SERS） 与高通量拉曼系统 （CCSPS） 相结合的新平台。该平台能够对基因突变进行超灵敏和快速的基因型分析。CCSPS 的开发专门针对 EGFR 突变，EGFR 突变是肺癌精准治疗的关键治疗靶点。该系统具有出色的灵敏度和选择性，能够检测多种 EGFR 突变（Del-19、L858R 和 T790M），检测限低至阿摩尔水平。此外，使用 CCSPS 对 42 个临床样本成功进行了精确的基因分型分析，产生的结果与通过下一代测序获得的结果一致。这些结果强调了 CCSPS 在无创识别循环肿瘤 DNA （ctDNA） 突变方面的疗效，有助于在床边立即做出治疗决策。总之，CCSPS 是一种快速、准确、多功能且紧凑的测试系统，能够精确筛查从靶向治疗中受益的个体，从而促进个性化和精准的医疗保健。