Co-Diagnostics, Inc.
For the period ended Mar 31, 2026. Filed Mar 31, 2026.
View on SEC.govAbout this filing
A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.
Mar 31, 2026 · Filed Mar 31, 2026
Use the contents to explore the available documents and sections.
Contents
EX-99.1 · Recent Developments:
Recent Developments:
| ● | Received CDSCO license to manufacture and sell the CoSara PCR Pro® instrument in India, representing a key regulatory milestone and enabling commercialization readiness |
| ● | Signed an agreement to expand CoSara Diagnostics’ commercial and distribution territory across South Asia to include Bangladesh, Pakistan, Nepal, and Sri Lanka, increasing the regional addressable market to approximately $13 billion |
| ● | Initiated shipments of PCR Pro® instruments and tuberculosis (TB) test* materials to India to support upcoming clinical performance studies, with the instrument and test kits being aligned with new WHO guidance on TB testing |
| ● | Strengthened the intellectual property portfolio with a new international patent granted in Japan |
“Over the past year, we made meaningful progress across multiple initiatives that have positioned the Company for its next phase of growth, including advancing our clinical pipeline, expanding our global footprint, and preparing for commercialization of the platform in 2026,” said Dwight Egan, Chief Executive Officer of Co-Diagnostics. “Importantly, we have remained focused on execution and continued to build momentum across the business. Our strategy is centered on four key pillars: advancing CoSara and our broader opportunity in India, executing on our CoMira joint venture in the Middle East and Northern Africa, progressing our clinical programs toward key regulatory milestones, and expanding our AI-driven capabilities. Together, these initiatives support our scalable, globally deployable diagnostics platform and reinforce our focus on long-term value creation.”
Mr. Egan continued, “Based on dramatically reduced rates of COVID prevalence in our clinical study locations, we are currently planning on an initial FDA 510(k) submission for our upper respiratory test focused on flu A, flu B, and RSV. As we move forward, we remain committed to disciplined performance as we advance toward commercialization, and we anticipate that this modified approach will allow us to accelerate regulatory and commercialization timelines while retaining the flexibility to incorporate COVID into the test at a later stage if conditions change.
“We believe the progress we’ve made in our clinical studies and on all other initiatives are creating a clear path to unlock the full potential of our platform as we enter the next phase of execution in 2026.”
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.