Digital Melt Curve Analysis Platform for Longitudinal Cancer Patient Monitoring

NIH RePORTER · NIH · R44 · $772,720 · view on reporter.nih.gov ↗

Abstract

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

Key facts

NIH application ID
10256226
Project number
1R44CA261523-01
Recipient
COMBINATI, INC.
Principal Investigator
Paul Ju-Sung Hung
Activity code
R44
Funding institute
NIH
Fiscal year
2021
Award amount
$772,720
Award type
1
Project period
2021-04-01 → 2021-05-11