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Digital Melt Curve Analysis Platform for Longitudinal Cancer Patient Monitoring

Award Number: R44CA261523
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2021
PERIOD OF PERFORMANCE END DATE: 05/11/2021

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Digital Melt Curve Analysis Platform for Longitudinal Cancer Patient Monitoring - 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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = -$562,690 )
2023	2021	COMBINATI INCORPORATED	3436 RAMBOW DR	PALO ALTO	CA	94306	SANTA CLARA	USA	Cancer Biology Research	000	1	3/13/2023	NEW	-$562,690
														Subtotal = -$562,690

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	COMBINATI INCORPORATED	3436 RAMBOW DR	PALO ALTO	CA	94306	SANTA CLARA	USA	Cancer Biology Research	000	1	2/28/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $772,720 )
2021	2021	COMBINATI INCORPORATED	3436 RAINBOW DRIVE	PALO ALTO	CA	94306	SANTA CLARA	USA	Cancer Biology Research	000	1	3/29/2021	NEW	$772,720
														Subtotal = $772,720

Grand Total All Awards = $210,030

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Digital Melt Curve Analysis Platform for Longitudinal Cancer Patient Monitoring

Award Number: R44CA261523

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/01/2021

PERIOD OF PERFORMANCE END DATE: 05/11/2021

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