Co-Diagnostics develops and sells PCR diagnostic test reagents and kits for detecting infectious diseases, including COVID-19, influenza, tuberculosis, hepatitis B and C, HPV, malaria, dengue, and Zika. The company sells these lab-based tests globally through distributors in over 50 countries to clinical labs and, in the U.S., to CLIA-certified labs. Co-Diagnostics also sells mosquito-vector surveillance PCR tests to municipal mosquito abatement districts in the U.S. The company's core proprietary technology is its Co-Primers system, a patented PCR primer and probe design that reduces false positives and enables multiplexing. Co-Diagnostics' central development initiative is the Co-Dx PCR platform, a compact point-of-care and at-home PCR system consisting of a handheld instrument, proprietary single-use test cups with lyophilized reagents, and a smartphone app that delivers results in roughly 30 minutes — all without requiring trained lab technicians or RNA/DNA extraction. The platform is not yet approved; Co-Diagnostics is pursuing FDA 510(k) clearance for respiratory, TB, and HPV tests. The intended business model is a razor-and-blade structure: place instruments and generate recurring revenue from test cups. Key geographies include the U.S., India (operated through the CoSara joint venture), and the MENA region (through the newly formed CoMira joint venture). The company is pre-commercialization, with current revenue consisting mostly of NIH and Gates Foundation grants, and funds operations through equity offerings and grant funding.
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