Micromolded Digital Nucleic Acid Test Consumable

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