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

基本信息

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
项目类别：
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

项目摘要

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

抽象的在为期 24 个月的第 2 阶段中，以其市售的 Absolute Q 数字 PCR 平台为基础 SBIR 项目，Combinati 将完成第一个数字熔解曲线分析 (DMCA) 的开发平台推向市场，进一步推动数字基因组学的采用，以实现高精度、灵敏的以及可重复的核酸定量，用于纵向患者监测。产品”解决方案并证明功能，我们将使用 Luminex 的 11- 演示 DMCA 平台 plex ESR1（雌激素受体 1）测定并在 Dana Farber 癌症研究所进行 Beta 测试： 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. 使用市售熔体校准套件在内部完成 dMCA 验证。 3. 使用 Luminex 展示 11 个无细胞 DNA 靶标的 <0.1% 突变等位基因频率公司的离散熔解测定。 4. 达纳法伯癌症研究所的 Beta 测试