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Micromolded Digital Nucleic Acid Test Consumable

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HG009640-01
Agency Tracking Number: R43HG009640
Amount: $215,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 172
Solicitation Number: PA16-302
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-03-01
Award End Date (Contract End Date): 2017-11-30
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: (510) 703-6887
Email: paul.hung@combinati.com
Research Institution
N/A
Abstract

Abstract
For the Phase 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 month Phase 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
Efficient running cost andlt $ COGS data point with the consumable technology which allows high
density reagent digitization on a standard format using a scalable manufacturing process
Open platform Off the shelf PCR reagents are compatible with the consumable without
purchasing of additional reagents such as oil for ddPCR
Value in CNV analysis Demonstrate a viable assay where digital analysis outperforms
conventional qPCR technology Narrative
There are growing scientific literature showing that nucleic acids could complement proteins as
next gen biomarkers when it comes to disease prognosis diagnosis as well as therapeutics monitoring
COMBiNATi will deliver the best in class digital nucleic acid test platform to enable precision
personalized medicine

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

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