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

项目总结/摘要 用于基因突变和个体化非侵入性检测的快速、多路生物传感器 非小细胞肺癌的治疗 迫切需要改进的血液液体活检，以帮助检测循环肿瘤DNA （ctDNA）。这种检测方法对于指导癌症治疗将是革命性的，因为ctDNA是一种非常特异的癌症。 生物标志物，可以收集非侵入性，从而解决了传统的侵入性组织的挑战， 活组织检查ctDNA的检测是具有挑战性的，因为这些生物标志物以痕量浓度存在，并且是 数量远远超过背景野生型DNA。Giner公司建议开发一种电化学检测 一种快速、灵敏、选择性检测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。的 开发的检测方法将适用于多重ctDNA检测，并使用肺癌患者血浆进行验证 样品，并集成到原型微流体装置，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NSCLC患者获得个性化治疗的机会， 更好的治疗结果，并提供比金标准数字PCR检测更具竞争力的优势 在较低的成本、最小化的样品制备要求、增加的多路检测以及更大的 更快的样本到答案的周转时间。

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.