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Self-Digitization Microfluidic Platform for Digital PCR

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44GM123797-01
Agency Tracking Number: R44GM123797
Amount: $1,144,304.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 400
Solicitation Number: PA18-591
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-04-01
Award End Date (Contract End Date): 2020-03-31
Small Business Information
7009 40TH AVE NE
Seattle, WA 98115-6005
United States
DUNS: 078456317
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (425) 220-2128
Business Contact
Phone: (206) 524-2330
Research Institution

Project Summary AbstractThis SBIR Direct Phase II project will produce a complete platform to perform nucleic acid quantificationNAQby digital polymerase chain reactiondPCRThe platform will consist of a complete instrument that
handles devices and executes all phases of the assaydigitizationamplificationand detectionin one
instrumentoffering truewalk awaycapabilities within a closed systemIt will also include a consumable chip
specifically tailored to high sensitivity applications such as circulating tumor DNActDNAresearch and
diagnosticsa rapidly growing market projected to exceed $billion byThe platform will be valuable for
biomedical research and clinical diagnostic applicationswith specific health related impact in areas such as
cancer diagnostics and treatment monitoringinfectious disease diagnosticsviral load monitoring and moreThe platform is based on Self DigitizationSDtechnologya simplerobust method that efficiently uses a
network of channels and wells to spontaneously partition samples into an array of predefined compartmentsThis platform is ideally suited for digital polymerase chain reactiondPCRapplicationsdPCR works by
partitioning samples into hundredsthousandsor even millions of individual volumes where each volume may
or may not contain target DNAOnly volumes with target DNA give a positive signal resulting in adigitalyes no signalfrom which Poisson statistics can then give direct determination of sample concentrationsDigital PCR directly provides absolute quantificationis robust against variations in reaction efficiencyis
incredibly sensitiveand has nearly unlimited resolution capabilitiesmaking it technically superior to the
current NAQgold standardof qPCRHoweverno commercial dPCR system is currently able to be compete
with qPCR because of issues with workflowthroughputand costAmong dPCR platformsthe SD mechanism
is uniquely suited to efficiently handle large sample volumeswhich provides a strong value proposition in highsensitivity applicationsand allows for direct competition with qPCR based assaysproviding a path to compete
in both the dPCR and qPCR marketThe primary objective of this proposal is to produce a platform that overcomes the workflowthroughputcostand flexibility hurdles that have limited existing commercial dPCR systemsparticularly in their inability to
penetrate the largerreal timeor qPCR marketThe first Aim will be development and construction of the
instrumentincluding a digitization mechanism that will preparesamples in parallela high speed
thermalcycling systeman imaging system to rapidly analyze samplesand integrated software to enable all
stages from a singlegocommandThe second Aim will be development of materials and device designs to
enable manufacturing of commercially viable devicesThe third Aim will encompass validation of the platform
with clinically relevant and valuable NAQ assaysSpecificallyit will be validated with an assay relevant to
ctDNA research and diagnostics Project Narrative
This research will generate a digital PCRdPCRplatform to perform nucleic acid quantificationNAQconsisting of a stand alone instrument withwalk awaycapabilitiesand commercially viable devices to
perform high sensitivity assaysThis instrument will offer unrivaled workflow capabilities and cost profiles that
will transform the dPCR market and enable inroads into the larger qPCR marketIt will impact and enable
many biological research and clinical applications including cancer diagnostics and treatment monitoringinfectious disease detectionand viral load monitoring

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

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