Co-Diagnostics (CODX)
Develops portable PCR instruments, test cups, and molecular assays.
Co-Diagnostics, Inc. (CODX) Q2 2026 Earnings Call Transcript
Co-Diagnostics, Inc. (CODX) Q2 2026 Earnings Call Transcript
Co-Diagnostics Reports Second Quarter 2026 Financial Results
Advancing Commercialization Through FDA Submission, Global Clinical Progress and Manufacturing Expansion Strengthening Integrated Co-Dx PCR Platform Through Scientific Innovation, Cloud Connectivity and AI-Enabled Capabilities SALT LAKE CITY, Aug. 13, 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 second quarter ended June 30, 2026. Second Quarter 2026 Business Highlights: Advanced CoMira Diagnostics' manufacturing strategy in the Kingdom of Saudi Arabia through Saudi approval for a manufacturing facility industrial site and execution of a lease agreement in Sudair Industrial City, supporting planned localized production and future commercialization across the Middle East and North Africa (MENA) Expanded commercial outreach through participation in a European trade mission with the Utah Governor's Office and World Trade Center Utah, while showcasing the Co-Dx PCR platform and CE-IVD solutions at ESCMID Global 2026 to engage prospective customers, distributors, and strategic partners Presented the Co-Dx PCR tuberculosis (TB) platform at the Stop TB Partnership Summit in Washington, D.C.
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 SALT LAKE CITY, Aug. 6, 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 submitted a Dual 510(k) premarket notification, with a concurrent CLIA Waiver by Application, to the U.S. Food and Drug Administration ("FDA") for the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument*. The submission follows the Company's previously announced completion of the clinical and analytical performance studies supporting the test.
Co-Diagnostics Announces Second Quarter 2026 Earnings Release Date and Webcast
SALT LAKE CITY, July 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 second quarter 2026 financial results on Thursday, August 13, 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-Diagnostics Appoints Wes Lindsey, PhD, MBA as Chief Scientific Officer
SALT LAKE CITY, July 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 the appointment of Wes Lindsey, PhD, MBA as the Company's new Chief Scientific Officer ("CSO"). Dr. Lindsey brings more than 20 years' experience in molecular diagnostics.
Co-Diagnostics Invited to Participate in NPOC Tuberculosis Diagnostics Workshop in Bangkok, Thailand
Invited by the Stop TB Partnership and the Global Fund to participate as a manufacturer partner 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 SALT LAKE CITY, July 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 it has been invited to participate as a manufacturer partner in the United Nations Office for Project Services' (UNOPS) Global Implementation Workshop on Near Point of Care (NPOC) TB Diagnostics in Bangkok, Thailand, July 8-10, 2026. The workshop is intended to bring together national tuberculosis ("MTB" or "TB") programs, national reference laboratories, implementers, researchers, donors, and technical agencies to share early implementation experience with NPOC platforms, to translate the new WHO guidelines on NPOC diagnostics (including tongue swabs and sputum pooling) into national policy and operational plans, and to support countries preparing the NPOC components of their Global Fund GC8 funding requests.
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 Analytical data to support concurrent 510(k) submission with CLIA Waiver by Application for point-of-care settings, with submission targeted for Q3 2026 SALT LAKE CITY, July 1, 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 the completion of clinical and analytical performance studies for the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument* that the Company currently expects to include in its planned submission package. Completion of these studies represents a significant milestone in preparation of a Dual 510(k) and CLIA Waiver by Application submission to the U.S. Food and Drug Administration ("FDA"), targeted for Q3 2026.
Co-Diagnostics Vector Smart® Division Expands Footprint to 21 States
Expansion coincides with Co-Dx webinar for prospective mosquito abatement district customers in honor of National Mosquito Control Awareness Week SALT LAKE CITY, June 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 its mosquito abatement district ("MAD") customer base for the Vector Smart® line of products and services have grown to include MADs in 21 states, with four new full laboratory installs added in June alone. The announcement coincides with Co-Dx hosting a webinar for prospective MAD customers in recognition of National Mosquito Control Awareness Week.
Co-Diagnostics Advances Latin American Commercialization Strategy for Co-Dx™ PCR Pro® with Mexico Distributor Agreement
Longstanding distribution partner to support future deployment of Co-Dx™ PCR Pro ® and expanding menu of molecular diagnostics products across a key Latin American market SALT LAKE CITY, June 11, 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 an exclusive distribution agreement with its longstanding partner in Mexico for the Co-Dx™ PCR point-of-care platform*, including the PCR Pro® instrument and associated test kits, advancing the Company's strategy to expand its commercialization network and footprint in Latin America ahead of the platform's market launch, which remains subject to applicable regulatory review and authorization. "We are pleased to continue building on our longstanding relationship in Mexico with a distributor that played an important role in the successful deployment of our molecular diagnostics products during the COVID-19 pandemic," said Dwight Egan, Chief Executive Officer of Co-Diagnostics.
Co-Diagnostics and CoSara Advance Ebola PCR Test Development and Co-Dx™ PCR Point-of-Care Platform Capabilities
Dual-assay strategy designed to support outbreak response and surveillance efforts in affected regions Potential blood-based Ebola assay would represent an important expansion of Co-Dx™ PCR point-of-care platform capabilities SALT LAKE CITY, June 2, 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 continued progress in its Ebola PCR development program with joint venture CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV").
Is Co-Diagnostics National Security's Next Diagnostic Pick?
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.
Co-Diagnostics, Inc. (CODX) Q1 2026 Earnings Call Transcript
Co-Diagnostics, Inc. (CODX) Q1 2026 Earnings Call Transcript
Co-Diagnostics Reports First Quarter 2026 Financial Results
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.
Co-Diagnostics Announces First Quarter 2026 Earnings Release Date and Webcast
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.
Co-Diagnostics Invited to Present at Stop TB Partnership Summit in Washington, D.C.
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.
Co-Diagnostics Executives to Participate in European Trade Mission with Utah Governor and WTC Utah
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
Co-Diagnostics, Inc. (CODX) Q4 2025 Earnings Call Transcript
Co-Diagnostics Reports Full Year 2025 Financial Results
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.
Co-Diagnostics Ships Diagnostic Materials to India for Initiation of Tuberculosis Clinical Studies Following Recently Issued Guidance from the World Health Organization
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.
EXCLUSIVE: Co-Diagnostics Ships Diagnostic Tests To India Ahead Of TB Study Launch
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.