Co-Diagnostics (CODX) Status update summary

Strategic Collaborations and Platform Development

• Entered a non-exclusive, early-stage collaboration with ReadyGo Diagnostics to develop blood-based molecular testing, initially focused on Ebola, leveraging ReadyGo's field-capable sample preparation technology and the Co-Dx PCR platform.

• The collaboration aims to create a practical, decentralized workflow for molecular testing in remote and resource-limited settings, supporting rapid outbreak response.

• Successful blood-based workflow could expand platform applications to a broader range of blood-borne pathogens, including HIV and hepatitis B/C, opening significant new market opportunities.

• The integrated approach combines sample preparation, molecular detection, and real-time data sharing to address urgent health challenges.

Manufacturing and Scalability Advancements

• Automated cartridge production lines have doubled throughput and reduced labor requirements by more than half, supporting efficient scale-up and international technology transfer.

• Transition from manual to automated production reduced cycle time by 82% (from 30.47 to 16.77 seconds) and increased projected output per shift by 164% (from 757 to 2,000 cups).

• Automation enhances quality control and consistency, enabling reliable replication of manufacturing processes in regions like India and Saudi Arabia.

• Over 600,000 cartridges have been produced to date, demonstrating readiness for increased demand.

Progress in India and Regional Market Context

• CoSara joint venture in India has expanded its installed base with 24 new PCR instruments and launched in-house oligonucleotide synthesis and extraction kit production.

• The diagnostic market in India and neighboring countries is estimated at $13 billion, with point-of-care diagnostics growing at 8.5% annually.

• Clinical studies for tuberculosis using the decentralized workflow are nearing completion, targeting regulatory submissions to India's CDSCO and the WHO ERPD.

• Clinical studies in India are validating a complete decentralized workflow for MTB (tuberculosis), with 24,774 positive cases out of 132,480 tests and an 18.7% national positivity rate.

• In-house capabilities for master mix, extraction kits, and oligonucleotide production are being expanded to support scalable, cost-efficient operations and future applications.