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Digital Melt Curve Analysis Platform for Longitudinal Cancer Patient Monitoring

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44CA261523-01
Agency Tracking Number: R44CA261523
Amount: $772,720.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: PAR18-303
Timeline
Solicitation Year: 2018
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-04-01
Award End Date (Contract End Date): 2023-03-31
Small Business Information
3436 RAMBOW DR
Palo Alto, CA 94306-3638
United States
DUNS: 080013010
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 PAUL HUNG
 (510) 703-6887
 paul.hung@combinati.com
Business Contact
 PAUL HUNG
Phone: (415) 890-6885
Email: paul.hung@combinati.com
Research Institution
N/A
Abstract

AbstractBuilding 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 andlt;0.1% Mutation Allele Frequency of 11 cell-free DNA targets using LuminexCorporation’s discrete melt assay.
4. Beta testing at Dana Farber Cancer InstituteNarrativeSince PCR was invented back in 1983, it has become the gold standard for applications requiring
quantification of nucleic acids. The continuous evolution of the technology enables PCR to be more
quantitative (qPCR), more accurate, precise and reproducible (digital PCR). In parallel, with the invention
of melt curve analysis in 1997, it opens another dimension in melt temperatures for applications requiring
simple and inexpensive genotyping, high degree qualitative multiplexing without sequencing, and assay
optimization. Despite that there is a handful of dPCR platforms in the market, none of them supports
Melt Curve Analysis. By combining melt curve analysis with digital PCR, Combinati strives to accelerate
the adoption of digital genomics for all nucleic acid quantification needs in research and clinical markets.

* Information listed above is at the time of submission. *

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