Digital Melt Curve Analysis Platform for Longitudinal Cancer Patient Monitoring

摘要 在24个月的第二阶段期间，建立在其商用的绝对Q数字聚合酶链式反应平台上 SBIR项目，Combinati将完成第一个数字熔化曲线分析(DMCA)的开发 平台推向市场，进一步推进数字基因组学的采用，实现高度准确、灵敏 以及可重复的核酸定量，用于纵向患者监测。以提供“整体” 产品“解决方案并证明其功能，我们将使用Luminex的11- Dana Farber癌症研究所的Plex ESR1(雌激素受体1)测试和Beta测试： 1.具有数字化熔体曲线分析功能的三台测试仪和分析软件。 2.使用市售的熔体校准套件在内部完成DMCA验证。 3.使用Luminex演示11个无细胞DNA靶点的0.1%突变等位基因频率 公司的离散熔融分析。 4.达纳·法伯癌症研究所的贝塔测试

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