Integrated Digital PCR Platform with a Micromolded Siphoning Array

Abstract Combinati is looking to bring an integrated digital PCR platform with injection molded microfluidic consumables from lab to marketplace to advance the biomedical research Digital PCR 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 no need for an internal standard high precision and access to well developed PCR reagents However current dPCR instruments are capital intensive cost per sample is high and the workflow is complicated The year Phase SBIR project will allow Combinati to complete the validation of the following key value hypothesis which will serve as the new product design spec for Phase commercialization effort Combinati s unique consumable technology allows high density reagent digitization on a standard format using a scalable manufacturing process The industry standard format allows integration of pneumatics thermal optical and software modules into one benchtop instrument to offer significant workflow advantage over current commercially available products Off the shelf PCR reagents are compatible with the platform without purchasing of specialized reagents Narrative There are increasing evidences showing that nucleic acids could complement proteins as additional biomarkers when it comes to disease prevention prognosis diagnosis as well as therapeutics efficacy monitoring Combinati is developing a precision nucleic acid quantification platform in the hope to accelerate the adoption of dPCR technology in the genomic research market and catalyze its transition from benchtop to bedside With the help from this Phase SBIR project we will prove the feasibility of an integrated digital PCR dPCR platform with the best combination of workflow easiness cost sample throughput run and performance experiment