Rapid, Multiplexed Biosensor for Non-Invasive Detection of Gene Mutations and Personalization of Therapy in Non-Small Cell Lung Cancer

项目摘要/摘要 用于非侵入性检测基因突变和个体化的快速、复合生物传感器 非小细胞肺癌的治疗 迫切需要改进的血液液体活组织检查来辅助检测循环的肿瘤DNA。 (CtDNA)。由于ctdna是一种非常特异的癌症，这种检测方法对于指导癌症治疗将是革命性的。 可以非侵入性收集的生物标记物，从而解决了传统侵入性组织的挑战 活组织检查。CtDNA的检测具有挑战性，因为这些生物标记物以微量浓度存在，并且 数量远远超过背景野生型DNA。吉纳公司建议开发一种电化学检测 一种快速、灵敏和选择性地检测与之相关的EGFR基因单碱基突变的方法 非小细胞肺癌(NSCLC)对酪氨酸激酶抑制剂(TKI)类药物的敏感性。这个 开发的方法将适用于多重ctdna检测，并与肺癌患者血浆进行验证。 样品，并集成到原型微流控设备中，从而实现了一个重要的里程碑， 监管评估。这项技术将有助于增加非小细胞肺癌患者获得个性化治疗的机会 更好的治疗结果，并提供比黄金标准数字聚合酶链式反应检测更具竞争力的竞争优势 在更低的成本方面，最大限度地减少了样品制备要求，增加了多路检测，以及更多 更快的样本到答案周转时间。

PROJECT SUMMARY/ABSTRACT Rapid, Multiplexed Biosensor for Non-Invasive Detection of Gene Mutations and Personalization of Therapy in Non-Small Cell Lung Cancer There is an urgent need for improved blood-based liquid biopsies to aid the detection circulating tumor DNA (ctDNA). Such assays will be revolutionary for guiding cancer treatment because ctDNA is a very specific cancer biomarker that can be collected non-invasively, thus addressing the challenges of traditional invasive tissue biopsies. Detection of ctDNA is challenging because these biomarkers exist at trace concentrations and are vastly outnumbered by background wild type DNA. Giner, Inc. proposes to develop an electrochemical detection method for rapid, sensitive, and selective detection of single-base mutations in the EGFR gene associated with sensitivity to the tyrosine kinase inhibitor (TKI) class of drugs in non-small cell lung cancer (NSCLC). The developed assay will be adapted for multiplexed ctDNA detection, validated with lung cancer patient plasma samples, and integrated into a prototype microfluidic device, thus achieving a significant milestone toward regulatory evaluation. This technology will help increase access of personalized therapies to NSCLC patients for better treatment outcomes, and offer a compelling competitive advantage over gold standard digital PCR tests in terms of lower cost, minimized sample preparation requirements, increased multiplexed detection, and a much faster sample-to-answer turnaround time.