For the Phase 1 SBIR project, COMBiNATi is looking to prove the feasibility of an injection molded 100k array digital PCR consumable for KRAS G12R cancer rare mutation quantification analysis. Digital PCR (dPCR) has drawn attentions in both cancer 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. Envisioned applications enabled by dPCR in cancer translational research and clinical applications include: ? Mutation guided prescription of cancer drugs for improved efficacy ? Liquid biopsy with cell-free nucleic acids for continuous therapeutic monitoring However, current dPCR platforms are slow to overtake the gold standard qPCR, despite its superior performance in rare mutation detection, mainly because the cost of consumables is high, and the workflow is complicated. Our vision is to develop an entry-level turnkey dPCR platform to allow load/walkaway workflow and the best-in-class combination of cost per sample, and performance per experiment, accelerating the transition from qPCR to dPCR in the cancer research community. The 9 month Phase 1 SBIR project will allow COMBiNATi to complete the feasibility of the following key value hypothesis, which will serve as the new product design spec for Phase 2 platform development effort: 1. High sensitivity: 0.01% (mutation to wildtype) detection limit. 2. Single workflow: Reagent partitioning, thermal cycling and image acquisition in one system. 3. Open platform: Off-the-shelf PCR reagents are compatible with the platform without purchasing of additional reagents from COMBiNATi.
There are increasing evidences showing that nucleic acids could complement proteins as additional biomarkers when it comes to cancer prognosis, diagnosis, as well as therapeutics efficacy monitoring. Combinati is developing a precision nucleic acid quantification platform building on its unique consumable technology in the hope to accelerate the adoption of digital PCR (dPCR) in the cancer genomic research market, in academic, industrial and clinical settings. Our goal is to accelerate its transition from benchtop to bedside. With the help from this Phase 1 SBIR project, we will prove the feasibility of the injection molded consumable for rare mutation detection with walkaway operation, as well as an open platform with standard qPCR reagents.
