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

用于非小细胞肺癌基因突变非侵入性检测和个性化治疗的快速多重生物传感器

基本信息

批准号：
9908983
负责人：
Castro S Laicer
金额：
$ 29.99万
依托单位：
GINER, INC.
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-17 至 2020-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9908983
关键词：
Address Adoption Alkynes American Archives Azides Benchmarking Biological Assay Biological Markers Biopsy Biosensor Blood Cancer Etiology Cancer Gene Mutation Cancer Patient Categories Cell Line Cessation of life Chemicals Chest Clinical Collaborations Consumption Custom DNA DNA Primers DNA Probes DNA amplification Detection Device Designs Devices Diagnosis Diagnostic Disease Disease Progression Drug resistance EGFR gene Early Diagnosis Early treatment Enzymes Epidermal Growth Factor Receptor Evaluation Exons FDA approved Gene Frequency Gene Mutation Genotype Goals Gold Head Hour Human Hybrids Institutes Intervention Laboratory Research Ligation Malignant Neoplasms Malignant neoplasm of lung Manufacturer Name Measures Mediating Medical Device Methods Microfluidic Microchips Microfluidics Modeling Molecular Biology Mutation Non-Invasive Cancer Detection Non-Small-Cell Lung Carcinoma Oncologist Outcome Oxidation-Reduction Patients Performance Pharmaceutical Preparations Pharmacologic Substance Phase Plasma Positioning Attribute Preparation Process Reaction Reporter Reporting Resistance Sampling Secure Sensitivity and Specificity Signal Transduction Small Business Innovation Research Grant Specificity System Techniques Technology Test Result Testing Time Tissues Training Translational Research Treatment outcome Tumor Tissue Tyrosine Kinase Inhibitor United States Validation Woman base cancer biomarkers cancer therapy clinical application clinical care clinical diagnostics clinically actionable commercialization cost cycloaddition design digital experience improved liquid biopsy men multiplex detection mutant personalized medicine point of care pre-clinical programs prototype rapid technique research and development resistance mutation sensor sensor technology targeted cancer therapy targeted treatment technology development treatment response tumor tumor DNA

项目摘要

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.

项目概要/摘要用于基因突变非侵入性检测和个体化的快速、多重生物传感器非小细胞肺癌的治疗迫切需要改进血液液体活检来帮助检测循环肿瘤 DNA （ctDNA）。此类检测对于指导癌症治疗将是革命性的，因为 ctDNA 是一种非常特殊的癌症可以非侵入性收集的生物标志物，从而解决传统侵入性组织的挑战活检。 ctDNA 的检测具有挑战性，因为这些生物标志物以微量浓度存在，并且其数量远远超过背景野生型 DNA。 Giner, Inc. 提议开发一种电化学检测方法快速、灵敏、选择性检测与 EGFR 基因相关的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。这开发的检测方法将适用于多重 ctDNA 检测，并用肺癌患者血浆进行验证样本，并集成到原型微流体装置中，从而实现了一个重要的里程碑监管评估。该技术将有助于增加 NSCLC 患者获得个性化治疗的机会更好的治疗结果，并提供比黄金标准数字 PCR 测试更具吸引力的竞争优势在降低成本、最小化样品制备要求、增加多重检测以及更多方面更快的样品到答案的周转时间。