CODX - Co-Diagnostics, Inc.
A structural shift is underway in the biodefense landscape. The declaration of a Public Health Emergency of International Concern (PHEIC) by the World Health Organization on May 17, 2026, for the Bundibugyo virus Ebola outbreak should be seen by investors as more than a headline, because it is a fundamental catalyst.
Joint development strategy has been developed to address international deployment requirements if current outbreak continues or expands globally SALT LAKE CITY, May 26, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has advanced the PCR assay development strategy for the Bundibugyo virus ("BDBV") currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo ("DRC") and Uganda, with the support of CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV"), the Indian joint venture between Co-Dx and Ambalal Sarabhai Enterprises Limited ("ASE Group").
SALT LAKE CITY, May 19, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx", or the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has entered into a securities purchase agreement with certain institutional investors to sell an aggregate of 1,647,447 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 3,294,894 shares of common stock, in a private placement priced at-the-market under Nasdaq rules (the "Offering"). The combined effective offering price for each share of common stock (or pre-funded warrant in-lieu thereof) and accompanying warrants to be issued is $1.821.
Recent pathogens illustrate need for improved situational awareness capabilities, such as those provided by the Co-Dx PCR point-of-care platform Follows outbreak of Ebola and WHO emergency declaration, and enhanced CDC traveler screening measures SALT LAKE CITY, May 19, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has completed the assay development strategy for the Bundibugyo virus ("BDBV") currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo and Uganda. "We are pleased to report that we have completed the assay development strategy for BDBV, and should a situation arise requiring the assay, we expect we would be well positioned to execute the strategy and rapidly make the test available," said Dwight Egan, Co-Diagnostics Chief Executive Officer.
Co-Diagnostics, Inc. (CODX) Q1 2026 Earnings Call Transcript
Advancing Global Commercialization Through CoSara Regulatory Progress and Regional Expansion Executing Clinical Strategy with Upper Respiratory Submission Preparation and TB Study Initiation Expanding International Presence and Reinforcing Platform Differentiation Through Partnerships and IP SALT LAKE CITY, May 14, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx," or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced its financial results for the first quarter ended March 31, 2026. First Quarter 2026 Business Highlights: Received CDSCO license to manufacture and sell the CoSara PCR Pro® instrument in India, marking a key regulatory milestone and supporting commercialization readiness Received ISO 13485 certification for CoSara's manufacturing facility in India, supporting regulatory submissions and meeting international quality standards Entered into an agreement to expand CoSara Diagnostics' commercial and distribution territory across South Asia to include Bangladesh, Pakistan, Nepal, and Sri Lanka, increasing the regional total 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 designed to support testing approaches reflected in recent WHO guidance on TB testing Strengthened distributor relationships and expanded market presence through CoSara Diagnostics' participation in regional conferences in India Showcased the Co-Dx PCR platform at industry events including Medical Korea 2026 in Seoul, South Korea and World Health Expo Labs Dubai in Dubai, UAE, highlighting the Company's point-of-care testing platform and engaging with global stakeholders Expanded the intellectual property portfolio with the issuance of a new international patent in Japan First Quarter 2026 Financial Results: Revenue of $0.15 million, compared to $0.05 million in the first quarter of 2025 Operating expenses of $9.2 million, compared to $8.6 million in the same period last year, driven by research and development spending on clinical studies and to advance other growth initiatives Operating loss of $9.2 million, compared to $8.6 million in the first quarter of 2025 Net loss of $9.1 million, or $4.06 per share, compared to a net loss of $7.5 million, or $7.05 per share, in the same period last year, primarily driven by higher operating expenses and lower other income, including the absence of certain remeasurement gains recognized in the prior-year period Adjusted EBITDA loss of $8.7 million, compared to a loss of $7.4 million in the first quarter of 2025 Cash and cash equivalents totaled $8.2 million as of March 31, 2026, compared to $11.9 million as of December 31, 2025.
Lease execution highlights transition from approval to development and advances localized manufacturing strategy in the Kingdom of Saudi Arabia in accordance with Vision 2030 SALT LAKE CITY, May 8, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that its joint venture, CoMira Diagnostics LLC ("CoMira"), has finalized a lease agreement for its planned manufacturing facility in Sudair Industrial City in the Kingdom of Saudi Arabia ("KSA"). The lease execution represents a key milestone as CoMira advances domestic manufacturing capabilities within the KSA and follows the Company's previously announced approval for an industrial land allocation in Sudair Industrial City by the Saudi Authority for Industrial Cities and Technology Zones ("MODON").
SALT LAKE CITY, April 30, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced it will release its first quarter 2026 financial results on Thursday, May 14, 2026, after the market close. The Company will also host a conference call and webcast on the same day at 4:30 p.m.
MTB test on Co-Dx PCR platform* to be presented at roundtable with Stop TB Partnership, U.S. Department of State, and global stakeholders SALT LAKE CITY, April 16, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has been invited to participate in the Stop TB Partnership Summit in Washington, D.C. on April 17, 2026.
Company to engage with global customers and distributors while expanding international commercial relationships SALT LAKE CITY, April 14, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced it will participate in the Congress of the European Society of Clinical Microbiology and Infectious Disease ("ESCMID Global") 2026, taking place April 17-21 in Munich, Germany. ESCMID Global 2026 features academic and industry programming that brings together clinical microbiology and infectious diseases leaders dedicated to advancing scientific, education, research and state-of-the-art technologies.
Trade mission itinerary of business, government, and industry briefings across Switzerland and Germany to include site visits to Roche Diagnostics, UBS, Zurich Innovation Park and more SALT LAKE CITY, April 9, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced Company executives will be participating in the latest World Trade Center (WTC) Utah trade mission with Utah Governor Cox and the Governor's Office of Economic Opportunity, taking place April 13-22 in locations across Switzerland and Germany. "Switzerland and Germany are home to many of the world's leading technology, diagnostics, financial and R&D environments," said Dwight Egan, Chief Executive Officer, Co-Diagnostics, Inc. "We are pleased to be part of this prestigious trade mission and to help further the goals of our community, while strengthening our own international network of strategic partners and advancing important Co-Dx initiatives.
Co-Diagnostics, Inc. (CODX) Q4 2025 Earnings Call Transcript
Advancing Global Commercialization Strategy Through CoSara and CoMira Joint Ventures Progressing Clinical Pipeline and Regulatory Pathways for PCR Platform Strengthening Technology Leadership with AI Integration and Expanding IP Portfolio SALT LAKE CITY, March 31, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (NASDAQ: CODX) ("Co-Diagnostics," "Co-Dx," or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced its financial results for the full year ended December 31, 2025. Full Year 2025 Financial Results: Revenue of $0.6 million, compared to $3.9 million in 2024, primarily due to lower grant revenue Operating expenses of $50.6 million, compared to $43.0 million in 2024, driven by a non-cash impairment charge of $18.9 million from revaluation of intangible assets Operating loss of $50.2 million, compared to $40.1 million in 2024 Net loss of $46.9 million, or $35.25 per share, compared to net loss of $37.6 million, or $37.22 per share in 2024, primarily due to intangible asset impairment charges and lower grant revenue, partially offset by decreases in operating expenses and a benefit from income taxes Adjusted EBITDA loss of $28.0 million, compared to a loss of $33.5 million in 2024 Cash, cash equivalents, and marketable investment securities totaled $11.9 million as of December 31, 2025, compared to $29.7 million as of December 31, 2024 Full Year 2025 Business Highlights: Closed $3.8 million offering of 9.62 million shares of common stock at an offering price of $0.40 per share on a pre-reverse split basis Closed $7.0 million offering of 12.7 million shares of common stock at an offering price of $0.55 per share on a pre-reverse split basis Continued advancement of CoSara Diagnostics joint venture in India, including regulatory progress and manufacturing readiness for PCR Pro® instrument* Signed definitive agreement with Arabian Eagle to establish CoMira Diagnostics joint venture in Saudi Arabia; currently progressing on execution and finalizing lease for manufacturing facility Initiated and advanced clinical evaluations of upper respiratory multiplex test Further progressed development across pipeline programs, including tuberculosis (TB) and HPV tests Expanded the AI business unit, integrating machine learning capabilities into the Co-Dx™ Primer Ai™ platform Strengthened the intellectual property portfolio with a new international patent granted in Australia Engaged Maxim Group to pursue SPAC transaction for CoSara Diagnostics Received recognition from Utah Governor's Office and BioUtah for the formation of CoMira Diagnostics 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.
The near-term commencement of clinical studies is expected to align with recent WHO tuberculosis recommendations for near-point-of-care molecular testing and utilizing tongue swab samples New recommendations are aligned with the design of Co-Dx's proprietary test, platform, and mission SALT LAKE CITY, March 25, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has commenced shipments of PCR Pro ® instruments*, Co-Dx™ PCR MTB test kits* for tuberculosis ("TB"), and proprietary sample preparation instruments to its joint venture CoSara Diagnostics Pvt. Ltd. ("CoSara") in India.
These materials are necessary to begin clinical performance studies of the TB test on the PCR platform, as the company completes final steps toward initiating those studies in the near term.
Expansion into Bangladesh, Pakistan, Nepal, and Sri Lanka increases TAM in region to $13 billion and supports commercialization strategy for the PCR Pro ® and SARAGENE ® product line SALT LAKE CITY, March 20, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that the Company has signed an agreement for CoSara Diagnostics Pvt. Ltd. ("CoSara"), the Indian joint venture between Co-Dx and Ambalal Sarabhai Enterprises Limited ("ASE Group"), to significantly expand its commercial and distribution territory across South Asia to now include Bangladesh, Pakistan, Nepal, and Sri Lanka.
CoSara is the Indian joint venture between Co-Dx and Ambalal Sarabhai Enterprises Limited.
SALT LAKE CITY, March 17, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced it will release its fourth quarter and full year 2025 financial results on Tuesday, March 31, 2026, after the market close. The Company will also host a conference call and webcast on the same day at 4:30 p.m.
Co-Dx to join WTC Utah and other Utah legislative and industry delegates March 19-22 in Seoul, South Korea SALT LAKE CITY, March 16, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that Co-Dx will accompany World Trade Center (WTC) Utah, the Utah Governor's Office of Economic Opportunity (GOEO), BioUtah, and other legislative and industry leaders at Medical Korea 2026, taking place March 19-22 in Seoul, South Korea. Co-Dx will participate in a healthcare business roundtable on March 19th and will conduct a presentation highlighting the Company's upcoming Co-Dx PCR point-of-care platform*.
SALT LAKE CITY, March 12, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that the Japan Patent Office ("JPO") has granted Japanese Patent No. 7797537, titled "Systems, Methods, and Apparatus for Automated Self-Contained Biological Analysis.