Digital Melt Curve Analysis Platform for Longitudinal Cancer Patient Monitoring


Year of Award:
2021
Status:
Complete
Award Type:
R44
Project Number:
CA261523
RFA Number:
PAR-18-303
Technology Track:
Molecular & Cellular Analysis Technologies
PI/Project Leader:
HUNG, PAUL JU-SUNG
Institution:
COMBINATI, INC.

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