Digital Melt Curve Analysis Platform for Longitudinal Cancer Patient Monitoring

摘要 基于其商用Absolute Q数字PCR平台，在为期24个月的第2阶段， 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”解决方案和证明功能，我们将展示DMCA平台与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

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