Digital Melt Curve Analysis Platform for Longitudinal Cancer Patient Monitoring

用于纵向癌症患者监测的数字熔解曲线分析平台

• 批准号: 10256226
• 负责人: Paul Ju-Sung Hung
• 金额: $ 77.27万
• 依托单位: COMBINATI, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2021-05-11
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10256226
• 关键词: Adopted; Adoption; Architecture; Back; Biological Assay; Blinded; Breast Cancer Patient; Calibration; Cancer Patient; Chemistry; Clinical; Collection; Color; Computer software; Computers; DNA; Dana-Farber Cancer Institute; Data; Data Analyses; Development; Dimensions; ESR1 gene; Evolution; Gene Frequency; Genomics; Genotype; Goals; Gold; Image; Image Analysis; Journals; Letters; Light; Mainstreaming; Manuscripts; Mechanics; Memory; Metastatic breast cancer; Microfluidics; Monitor; Mutation; Nucleic Acids; Optics; Oranges; Patient Monitoring; Patients; Peer Review; Performance; Phase; Process; Protocols documentation; Publications; Reagent; Reproducibility; Research; Resolution; Risk; Running; Sampling; Science; Small Business Innovation Research Grant; Source; Speed; System; Technology; Temperature; Testing; Time; Training; Validation; cell free DNA; clinically relevant; cost; cyanine dye 5; data exchange; design; detection limit; digital; fluorescence imaging; graphical user interface; image processing; improved; instrument; invention; lens; liquid biopsy; machine learning algorithm; meetings; melting; multidimensional data; mutant; mutation assay; neural network; product development; sensor; simulation

Abstract Building on its commercially available Absolute Q digital PCR platform, during the 24-month Phase 2 SBIR project, Combinati will complete the development of the first Digital Melt Curve Analysis (DMCA) platform to the market to further advance the adoption of digital genomics for highly accurate, sensitive and reproducible nucleic acid quantification for longitudinal patient monitoring. To provide the “whole product” solution and prove the function, we will demonstrate the DMCA platform with Luminex’s 11- plex ESR1 (Estrogen Receptor 1) assay and conduct Beta testing at Dana Farber Cancer Institute: 1. Three beta instruments and the analysis software capable of digital melt curve analysis. 2. Complete dMCA validation internally with commercially available melt calibration kits. 3. Demonstrate <0.1% Mutation Allele Frequency of 11 cell-free DNA targets using Luminex Corporation’s discrete melt assay. 4. Beta testing at Dana Farber Cancer Institute

摘要 在为期24个月的第二阶段，以其商用Absolute Q数字PCR平台为基础 SBIR项目，Combinati将完成第一个数字熔融曲线分析（DMCA）的开发 平台推向市场，以进一步推动数字基因组学的采用， 以及用于纵向患者监测的可再现的核酸定量。提供“全 产品”解决方案并证明功能，我们将使用Luminex的11- plex ESR 1（雌激素受体1）检测并在Dana Farber癌症研究所进行β检测： 1.三台beta仪器和能够进行数字熔解曲线分析的分析软件。 2.使用市售熔解校准试剂盒完成dMCA内部验证。 3.使用Luminex证明11个无细胞DNA靶标的突变等位基因频率<0.1% 公司的离散熔解测定。 4. Dana Farber癌症研究所的Beta测试