Micromolded Digital Nucleic Acid Test Consumable

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Abstract For the Phase 1 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 9 month Phase 1 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 2: 1. Efficient running cost: <$2 COGS/data point with the consumable technology which allows high density reagent digitization on a standard format using a scalable manufacturing process. 2. Open platform: Off-the-shelf PCR reagents are compatible with the consumable without purchasing of additional reagents such as oil for ddPCR. 3. Value in CNV analysis: Demonstrate a viable assay where digital analysis outperforms conventional qPCR technology.