Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test
Submission includes a concurrent CLIA Waiver by Application for use of the test on the Co-Dx PCR Pro® instrument in decentralized point-of-care settings.
Co-Diagnostics Raises Capital Through Warrant Inducement Ahead of FDA Review
A company still awaiting its first FDA clearance just structured a capital raise around the urgency of that wait. On July 30, 2026, Co-Diagnostics, Inc. entered into a warrant inducement agreement with existing warrant holders, convincing them to exercise warrants early in exchange for new warrants at revised terms. The transaction is straightforward on its […]
Co-Diagnostics Invited to Participate in NPOC Tuberculosis Diagnostics Workshop in Bangkok, Thailand
Workshop brings together national TB programs, researchers, donors, and technical agencies from 21 countries to advance implementation of WHO-recommended near-point-of-care diagnostics.
Co-Diagnostics Completes Clinical and Analytical Studies in Preparation for FDA 510(k) Submission of Upper Respiratory Point-of-Care Test
More than 1,400 patients enrolled across 9 clinical sites; analytical performance testing included 27 individual studies and over 10,000 PCR test cup runs.
Co-Diagnostics Advances Ebola PCR Assay Development Strategy with Joint Venture CoSara
Joint development strategy has been developed to address international deployment requirements if current outbreak continues or expands globally
Co-Diagnostics Joint Venture CoSara Receives CDSCO License to Manufacture and Sell CoSara PCR Pro™ Instrument
CDSCO license on Form MD-5 authorizes CoSara to manufacture PCR Pro instrument in its Ranoli, India facility for sale or distribution
Co-Diagnostics Receives Grant of Australian Patent Covering Co-Dx PCR Platform Technologies
The Australian patent represents the first patent granted for the Company’s new point-of-care testing platform.
Co-Diagnostics Joint Venture, CoSara, Invited to Participate in 2nd Advanced TB Diagnostics Course in Chennai, India
Co-Diagnostics Joint Venture, CoSara, Invited to Participate in 2nd Advanced TB Diagnostics Course in Chennai, India
Co-Diagnostics to Integrate and Implement Proprietary Artificial Intelligence Technology into Co-Dx™ Primer Ai™ Platform
Company forms new AI business unit, led by Chief Technology & AI Officer Christopher Thurston, to unify and advance Co-Dx’s existing and future AI initiatives
Co-Diagnostics Signs Definitive Agreement with Arabian Eagle in the Kingdom of Saudi Arabia to Establish CoMira Diagnostics and Localize Co-Dx™ PCR Platform Across the Middle East
The new Saudi-based CoMira Diagnostics joint venture will be engaged in manufacturing and distribution of the Company’s upcoming Co-Dx™ PCR platform and other Co-Dx IP across KSA and 18 other MENA countries
Co-Diagnostics, Inc. Signs Strategic MOU with Partner in Kingdom of Saudi Arabia to Introduce Co-Dx™ PCR Platform to Middle East
The Memorandum of Understanding includes the formation of a Joint Venture in the Kingdom of Saudi Arabia for manufacturing and distribution of the Company’s upcoming Co-Dx™ PCR platform and other Co-Dx IP
Co-Diagnostics, Inc. Submits First FDA 510(k) Application for Co-Dx PCR Pro Platform
The Company expects that the application for OTC clearance will shortly be followed by pursuit of POC clearance, with other tests in the pipeline to meet the needs of a global market
