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 2 year Phase 1 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 2 commercialization effort: 1. Combinati?s unique consumable technology allows high density reagent digitization on a standard format using a scalable manufacturing process. 2. 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. 3. Off-the-shelf PCR reagents are compatible with the platform without purchasing of specialized reagents.
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 1 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.