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Micromolded Digital Nucleic Acid Test Consumable

Award Number: R43HG009640
ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/01/2017
PERIOD OF PERFORMANCE END DATE: 11/30/2017

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Micromolded Digital Nucleic Acid Test Consumable - Abstract For the Phase 1 SBIR project, COMBiNATi will prove the feasibility of an array digital PCR (adPCR) consumable using copy number variation (CNV) analysis as the application. Digital PCR (dPCR) technology has drawn attentions in both genomic research and clinical research communities for its ability to detect rare events (high sensitivity), less prone to inhibition (high specificity), quantify without a standard curve (high precision), and access to well-developed qPCR reagents. Applications which could benefit from the high precision nature of dPCR include: ¿ Quantification or validation of NGS (Next Gen Sequencing) library to maximize yield ¿ Highly sensitive viral load test for early disease interception ¿ Mutation guided prescription of cancer drugs for improved efficacy ¿ Liquid biopsy with nucleic acids for continuous therapeutic monitoring However, current dPCR platforms are slow to overtake the current gold standard qPCR, mainly because the cost of consumables is high, the workflow is complicated, and the commercially available platforms are not amenable to automation. With the proposed adPCR consumable technology, we will deliver the first turnkey dPCR platform with efficient running cost for absolute nucleic acid quantification. The 9 month Phase 1 SBIR project will allow COMBiNATi to complete the following key value hypothesis of our consumable, which will serve as the new product design spec for platform development effort in Phase 2: 1. Efficient running cost: <$2 COGS/data point with the consumable technology which allows high density reagent digitization on a standard format using a scalable manufacturing process. 2. Open platform: Off-the-shelf PCR reagents are compatible with the consumable without purchasing of additional reagents such as oil for ddPCR. 3. Value in CNV analysis: Demonstrate a viable assay where digital analysis outperforms conventional qPCR technology.


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: 2018 ( Subtotal = $0 )
2018	2017	COMBINATI INCORPORATED	3436 RAINBOW DRIVE	PALO ALTO	CA	94306	SANTA CLARA	USA	Human Genome Research	000	1	5/25/2018	NEW	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $215,000 )
2017	2017	COMBINATI INCORPORATED	3436 RAINBOW DRIVE	PALO ALTO	CA	94306	SANTA CLARA	USA	Human Genome Research	000	1	2/24/2017	NEW	$215,000
														Subtotal = $215,000

Grand Total All Awards = $215,000

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Micromolded Digital Nucleic Acid Test Consumable

Award Number: R43HG009640

ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/01/2017

PERIOD OF PERFORMANCE END DATE: 11/30/2017

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