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High Density Array Digital PCR for Cancer Rare Mutation Quantification

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43CA221597-01A1
Agency Tracking Number: R43CA221597
Amount: $225,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 100
Solicitation Number: PA16-302
Solicitation Year: 2016
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-04-01
Award End Date (Contract End Date): 2019-03-31
Small Business Information
Palo Alto, CA 94306-3638
United States
DUNS: 080013010
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (510) 703-6887
Business Contact
Phone: (415) 890-6885
Research Institution

AbstractFor the PhaseSBIR projectCOMBiNATi is looking to prove the feasibility of an injection moldedk array digital PCR consumable for KRAS GR cancer rare mutation quantification analysisDigital
PCRdPCRhas drawn attentions in both cancer genomic research and clinical research communities for
its ability to detect rare eventshigh sensitivityless prone to inhibitionhigh specificityno need for an
internal standardhigh precisionand access to well developed PCR reagentsEnvisioned applications
enabled by dPCR in cancer translational research and clinical applications includeMutation guided prescription of cancer drugs for improved efficacyLiquid biopsy with cell free nucleic acids for continuous therapeutic monitoringHowevercurrent dPCR platforms are slow to overtake the gold standard qPCRdespite its superior
performance in rare mutation detectionmainly because the cost of consumables is highand the
workflow is complicatedOur vision is to develop an entry level turnkey dPCR platform to allow
load walkaway workflow and the best in class combination of cost per sampleand performance per
experimentaccelerating the transition from qPCR to dPCR in the cancer research communityThemonth PhaseSBIR project will allow COMBiNATi to complete the feasibility of the following
key value hypothesiswhich will serve as the new product design spec for Phaseplatform
development effortHigh sensitivitymutation to wildtypedetection limitSingle workflowReagent partitioningthermal cycling and image acquisition in one systemOpen platformOff the shelf PCR reagents are compatible with the platform without purchasingof additional reagents from COMBiNATi NarrativeThere are increasing evidences showing that nucleic acids could complement proteins as
additional biomarkers when it comes to cancer prognosisdiagnosisas well as therapeutics efficacy
monitoringCombinati is developing a precision nucleic acid quantification platform building on its
unique consumable technology in the hope to accelerate the adoption of digital PCRdPCRin the
cancer genomic research marketin academicindustrial and clinical settingsOur goal is to accelerate its
transition from benchtop to bedsideWith the help from this PhaseSBIR projectwe will prove the
feasibility of the injection molded consumable for rare mutation detection with walkaway operationas
well as an open platform with standard qPCR reagents

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

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