Topic 353: Highly Accurate Low Cost ctDNA Diagnostics with Magnetic Nanoparticle Enabled Automated Sample Prep - Moonshot

这项研究的目标是开发一种高精度、自动化和低成本的ctDNA测试，通过识别血浆样本中是否出现某些DNA突变来监测转移性乳腺癌患者的治疗效果。越来越多的证据表明，血流中某些DNA突变的存在与乳腺癌对激素治疗产生抵抗有关。NVIGEN将开发一种测试，可以足够早地检测到这些DNA突变的出现，以便医生可以开出更有效的治疗方案，以改善患者的预后。这项测试包括使用NVIGEN专有的分子工程磁性纳米颗粒从血液样本的血浆部分捕获DNA，并在自动化工作流程中对特定DNA突变的高度敏感目标进行浓缩。在拟议的计划中，NVIGEN将优化工作流程，确认测试检测多种相关DNA突变的能力，并进行临床验证，以验证测试检测到的DNA突变与治疗效果相关，为医生选择更有效的乳腺癌患者治疗方法提供依据。这项测试不仅将帮助乳腺癌患者，而且该技术还可以扩展到更广泛的其他癌症类型。

The goal of the research is to develop a highly accurate, automated, and low-cost ctDNA test to monitor efficacy of treatment of metastatic breast cancer patients by identifying the emergence of certain DNA mutations in plasma samples. There is growing evidence that the presence of certain DNA mutations in the blood stream correlates with breast cancer becoming resistance to hormone treatment. NVIGEN will develop a test that can detect the emergence of these DNA mutations early enough so that Physicians can prescribe a more effective treatment to improve patient outcome. The test involves captureing DNA from the plasma portion of blood samples using NVIGEN's proprietary molecularly engineered magnetic nanoparticles combined with highly sensitive target enrichment of specific DNA mutation in an automated workflow. During the proposed program, NVIGEN will optimize the workflow, confirm the test's ability to detect multiple relevant DNA mutations, and conduct clinical validations to verify that the DNA mutations detected by the test correlate with efficacy of treatment providing a basis for physicians to select more effective treatments for breast cancer patients. This test will not only help breast cancer patients but the technology can also be extended for a broad range of other cancer types.