Co-Diagnostics, Inc.
For the period ended Aug 13, 2026. Filed Aug 13, 2026.
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Aug 13, 2026 · Filed Aug 13, 2026
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Contents
EX-99.1 · Recent Developments:
Recent Developments:
| ● | Completed the clinical and analytical performance studies supporting the Company’s FDA 510(k) submission for the Co-Dx PCR Flu A/B & RSV test on the Co-Dx PCR Pro instrument, including a clinical study enrolling more than 1,400 patients across nine U.S. clinical sites and an analytical program spanning 27 studies and more than 10,000 PCR test runs |
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| ● | Submitted a 510(k) premarket notification, together with a concurrent CLIA Waiver by Application, to the U.S. Food and Drug Administration for the Co-Dx PCR Flu A/B & RSV test on the Co-Dx PCR Pro instrument, marking a significant regulatory milestone toward commercialization of the Company’s point-of-care molecular diagnostics platform |
| ● | Appointed Wes Lindsey, Ph.D., MBA, as Chief Scientific Officer to lead the Company’s scientific and regulatory strategy, including FDA submissions and continued expansion of the Co-Dx product pipeline |
| ● | Initiated clinical performance studies in India for the CoSara PCR MTB test through CoSara Diagnostics, advancing the Company’s tuberculosis commercialization strategy in one of the world’s largest TB markets |
| ● | The Company’s joint venture, CoSara Diagnostics provided Bundibugyo virus test kits for analytical studies in India and continued development of a pan-Ebola assay strategy, while the Company successfully completed a proof-of-concept study evaluating extraction-free plasma-based testing capabilities on the Co-Dx PCR platform |
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