• They're like the Intel for the molecular diagnostics industry, providing the essential 'processors' (reagents) that power disease detection tests.
• Think of them as a focused Abbott Laboratories for PCR-based diagnostic tests, developing kits for everything from COVID-19 to mosquito-borne illnesses, and even portable testing devices.
• They are like a Carvana for lab-quality diagnostic tests, aiming to make sophisticated molecular testing (like PCR) more accessible, even at point-of-care or at home.

• PCR Diagnostic Reagents: These are core components developed, manufactured, and sold for diagnostic tests that detect and analyze nucleic acid molecules.
• PCR Diagnostic Tests: A variety of diagnostic tests for infectious diseases including COVID-19, tuberculosis, hepatitis B and C, human papilloma virus, malaria, chikungunya, dengue, and the zika virus.
• Multiplexed Mosquito Tests: Three specific tests designed to identify diseases carried by mosquitos.
• Molecular Tools: Products for the detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications, including identifying genetic traits in plant and animal genomes.
• Portable PCR Device: A device designed to bring PCR testing capabilities to patients in point-of-care and at-home settings.
• Integrated Lab Systems: Self-contained laboratory systems comprising diagnostic equipment from other manufacturers, intended for resale.

Co-Diagnostics, Inc. (CODX) primarily sells its molecular diagnostics products, reagents, and testing equipment to other companies and organizations, rather than directly to individuals. While specific major customer names are not publicly disclosed in the provided background information (and are generally not made public by companies in this industry unless a customer represents a significant portion of revenue), Co-Diagnostics' clientele can be categorized based on its product offerings and target applications:

• Clinical and Diagnostic Laboratories: This broad category includes hospitals, independent diagnostic laboratories, and various point-of-care settings. These customers utilize Co-Diagnostics' PCR diagnostic tests (e.g., for COVID-19, tuberculosis, hepatitis B and C, human papilloma virus), reagents, molecular tools for infectious disease detection, and liquid biopsy solutions for cancer screening. They also serve as potential users for the portable PCR device.
• Public Health Organizations and Government Agencies: These entities are major customers for large-scale testing programs, disease surveillance (e.g., for mosquito-borne viruses like dengue, chikungunya, and zika), and public health initiatives, particularly concerning infectious disease outbreaks and environmental monitoring.
• Agricultural and Veterinary Sector: Companies and institutions in this sector purchase tests for identifying genetic traits in plant and animal genomes, supporting applications in agriculture, animal health, and breeding programs.

Dwight H. Egan, Chief Executive Officer, Co-President and Chairman of the Board

Mr. Egan is a co-founder of Co-Diagnostics, Inc., and has served as an officer and director since April 2013. He has been involved in private investment since February 1999. Previously, he was a senior executive at Data Broadcasting Corporation from 1995 to 1999, a provider of wireless, real-time financial market data. Mr. Egan also co-founded Broadcast International, Inc. in 1984, serving as its CEO and Chairman of the Board until its acquisition by Data Broadcasting Corporation in 1995, which led to the creation of CBS MarketWatch, a financial news site that underwent an initial public offering. His experience includes directing a public company and working with capital markets.

Brian L. Brown, CPA, Chief Financial Officer, Secretary and Principal Accounting Officer

Mr. Brown was appointed Chief Financial Officer in February 2021. Prior to joining Co-Diagnostics, he served as CFO of A-Core Concrete Cutting, Inc., a privately held specialty construction company. He also held roles as Vice President of Accounting, Treasury & Investor Relations, and Director of Finance for Sportsman's Warehouse Holdings, Inc. (Nasdaq: SPWH), a publicly traded outdoor sporting goods retailer, for over 10 years. Mr. Brown is a licensed CPA in Utah and holds both a Master of Professional Accountancy and a Bachelor of Arts in Accounting from the University of Utah. His responsibilities have included SEC reporting, internal controls, audits, mergers and acquisitions, and financial forecasting.

Richard Abbott, President

Mr. Abbott was appointed President of Co-Diagnostics, Inc. in March 2024. Before this role, he served as President of Advanced Conceptions, Inc., a wholly-owned subsidiary of Co-Diagnostics since December 2021, where he was instrumental in establishing the teams and technology for the Co-Dx PCR platform. With over 25 years of experience in senior leadership positions within in-vitro diagnostics companies, Mr. Abbott's background includes serving as VP of Engineering at BioFire Diagnostics, where he led cross-functional teams that generated billions of dollars in revenue. He holds a Master of Science degree from Brigham Young University and an M.B.A. from the Wharton Business School.

Seth Egan, Chief Commercialization Officer

Mr. Egan is a co-founder of Co-Diagnostics, Inc. and has spearheaded the company's sales, marketing, and product commercialization efforts since its inception. He has been pivotal in executive management, including company operations, financings, product introductions, and managing the Co-Dx/CoSara joint venture relationship in India. His leadership has contributed to the sale of approximately 35 million Logix Smart® tests globally. Mr. Egan earned a Bachelor of Science in Business Communications from Utah Valley University.

Christopher Thurston, Chief Technology Officer and AI Officer

Mr. Thurston was appointed Chief Technology Officer in March 2024. He has a history of developing software platforms for companies such as Ernst and Young and BioMerieux. As a co-inventor of the Co-Dx PCR platform at Idaho Molecular, which was acquired by Co-Dx in 2021, he now leads the company's newly formed artificial intelligence business unit. In this role, Mr. Thurston is responsible for integrating proprietary AI applications into the Co-Dx™ Primer Ai™ platform.

Key Risks to Co-Diagnostics (CODX)

1. Financial Viability Due to Significant Revenue Decline and High Cash Burn: Co-Diagnostics has experienced a drastic reduction in revenue following the maturation of the COVID-19 testing market. For example, Q3 2025 revenue was only $0.1 million, a substantial decline from previous periods. The company is operating at a significant net loss, which was $5.9 million in Q3 2025. This situation is unsustainable without constant financing, as operating expenses vastly exceed current revenue. The company's limited cash and marketable securities, which stood at $11.4 million as of September 30, 2025, provide a very short cash runway, sufficient for only a few quarters of operation.
2. Regulatory Challenges and Delays in Commercializing New Diagnostic Platforms: A critical risk stems from delays in obtaining regulatory approvals, particularly for its Co-Dx PCR platform (including the Co-Dx PCR Home™ and Co-Dx PCR Pro™). The entire platform remains under regulatory review and is not yet available for sale, pushing back crucial revenue-generating commercialization timelines. Management's target for commercialization in mid-2026 is highly contingent on successful and timely resubmission to regulatory bodies like the U.S. Food and Drug Administration (FDA). A prior US FDA submission withdrawal in February 2025 underscores the challenges in this area.
3. Market Dependence and Intense Competition Post-COVID-19 Pandemic: Co-Diagnostics' revenue was heavily reliant on its COVID-19 diagnostic kits, and the decline in demand for these tests has significantly impacted its financial performance. The company is currently undergoing a "post-pandemic platform pivot" to develop and commercialize new multiplex tests for point-of-care use. However, the molecular diagnostics market is intensely competitive, and successfully establishing a strong position with its new pipeline, while also navigating customer demands for comprehensive solutions, presents a significant ongoing challenge.

Co-Diagnostics (NASDAQ: CODX) operates within several significant addressable markets for its molecular diagnostic products and services.

• Infectious Disease Molecular Diagnostics Market (Global): The global infectious disease molecular diagnostics market size was calculated at approximately USD 46.03 billion in 2024 and is expected to reach around USD 63.37 billion by 2034. This market encompasses a broad range of molecular tests for infectious agents, including many of the diseases Co-Diagnostics targets. The Polymerase Chain Reaction (PCR) segment accounted for the largest revenue share in 2024 within this market.
• PCR Molecular Diagnostics Market (Global): The global PCR molecular diagnostics market size was valued at USD 8.67 billion in 2024 and is projected to grow to USD 14.28 billion by 2033, exhibiting a compound annual growth rate (CAGR) of 5.7%. Another estimate places the global PCR market at USD 10.75 billion in 2025, growing to USD 22.81 billion by 2034.
• COVID-19 Diagnostic Tests Market (Global): The global COVID-19 diagnostics market size reached USD 58.3 billion in 2024. However, it is projected to decline to USD 29.0 billion by 2033.
• Tuberculosis Diagnostic Tests Market (Global): The global tuberculosis diagnostics test market size was estimated at USD 2.4 billion in 2024 and is expected to grow to USD 4.1 billion by 2034. In North America, this market stood at USD 0.62 billion in 2023, with the U.S. market projected to reach USD 0.67 billion by 2026.
• Hepatitis B and C Diagnostic Tests Market (Global): The global hepatitis diagnostic tests market size was valued at USD 3.82 billion in 2023 and is expected to reach USD 5.90 billion by 2030. The North America hepatitis diagnostic tests market dominated in 2023 with a revenue share of 42.7%.
• Human Papillomavirus (HPV) Testing Market (Global): The global HPV testing market size is anticipated to rise from US$ 1,400 million in 2025 to US$ 2,816.3 million by 2032. For the combined HPV testing and Pap test market, the global size was valued at USD 4.7 billion in 2025, projected to reach USD 7.2 billion by 2034. North America is the largest market, accounting for approximately 50% of the global share for HPV testing.
• Malaria Diagnostics Market (Global): The global malaria diagnostics market size was valued at around USD 819.1 million in 2023 and is estimated to grow at a 5% CAGR from 2024 to 2032. The U.S. malaria diagnostics market size reached USD 303.1 million in 2023.
• Mosquito-borne Infections Testing Market (Global): The global mosquito-borne infections testing market size was calculated at USD 27.11 billion in 2024 and is predicted to increase to approximately USD 39.52 billion by 2034. This market includes tests for diseases such as dengue, malaria, and Zika virus.
• Liquid Biopsy Market for Cancer Screening (Global): The global liquid biopsy market size was estimated at USD 7.05 billion in 2025 and is predicted to rise to USD 22.69 billion by 2034. North America accounted for the largest market share of 45.59% in 2024. The U.S. liquid biopsy market is projected to rise from US$ 2.78 billion in 2026 to US$ 8.90 billion by 2035.
• Point-of-Care (POC) Molecular Diagnostics Market / Portable PCR Devices (Global): The global point-of-care molecular diagnostics market size was calculated at US$ 4.05 billion in 2024, growing to US$ 4.48 billion in 2025, and is projected to reach around US$ 11.03 billion by 2034. North America held approximately a 40-45% share in the global point-of-care molecular diagnostics market in 2024.
• Agricultural Applications (Molecular Tools): null

1. Launch and Commercialization of the Co-Dx PCR Point-of-Care Platform and New Diagnostic Tests: Co-Diagnostics is actively focused on bringing its proprietary Co-Dx PCR platform to the point-of-care market. This includes a robust pipeline of diagnostic tests for critical indications such as Tuberculosis (TB), an enhanced COVID-19 test, a 4-plex respiratory panel (influenza A/B, COVID-19, RSV), and an 8-plex Human Papillomavirus (HPV) panel. Clinical evaluations for these tests commenced in 2025, with commercialization in target markets anticipated as early as mid-2026, pending necessary regulatory approvals from bodies like the U.S. FDA, SAHPRA in South Africa, and CDSCO in India. The company believes its platform can revolutionize infectious disease testing by making it more affordable, accessible, and decentralized.
2. Geographic Market Expansion: The company is strategically expanding its presence in international markets, with a particular focus on India and South Africa. India is identified as a top priority for TB testing, with plans for regulatory submissions and leveraging the existing footprint of its joint venture, CoSara Diagnostics, for manufacturing and commercialization. CoSara has already received a CDSCO license to manufacture and sell the CoSara PCR Pro™ Instrument in India and obtained ISO 13485 certification. Additionally, Co-Diagnostics has secured patents for its Co-Dx PCR platform technologies in Japan and Australia, further strengthening its international intellectual property protection and supporting global market expansion. The Middle East market is also being targeted for respiratory infectious disease diagnostics.
3. Increased Adoption of Decentralized Point-of-Care and At-Home Diagnostic Testing: Co-Diagnostics is positioned to capitalize on the growing market trend towards decentralized diagnostic solutions, including point-of-care and at-home testing. The Co-Dx PCR platform is specifically designed to deliver gold-standard PCR accuracy in compact, user-friendly devices suitable for near-patient environments. The rising patient preference for rapid and convenient testing in settings like physician offices is projected to fuel significant growth in the respiratory infectious disease diagnostics market, which the Co-Dx platform addresses.

Share Repurchases

• Co-Diagnostics authorized a share repurchase program of up to $30.0 million in March 2022.
• By June 30, 2025, the company completed repurchases totaling approximately $15.58 million for 4,848,678 shares under the program.

Share Issuance

• Between December 31, 2024, and September 30, 2025, Co-Diagnostics issued approximately 15 million shares.
• Following the third quarter of 2025, a Registered Direct Offering (RDO) generated approximately $7.0 million in gross proceeds.
• A 1-for-30 reverse stock split was implemented effective January 2, 2026, to regain Nasdaq compliance and reduce the number of outstanding shares.

Inbound Investments

• In 2023, the company received approximately $12.6 million in grant funding to support regulatory and clinical validation activities for its tuberculosis (TB) test, upper respiratory multiplex panel, and human papillomavirus (HPV) test development.

Outbound Investments

• In the third quarter of 2025, Co-Diagnostics formed CoMira Diagnostics, a joint venture with Arabian Eagle Manufacturing, to commercialize Co-Dx technologies and intellectual property across KSA and 18 MENA nations.
• The company engaged Maxim Group LLC in Q3 2025 to explore a potential strategic transaction, including a SPAC transaction, for its existing joint venture in India, CoSara Diagnostics.

Capital Expenditures

• In 2024, Co-Diagnostics inaugurated a new manufacturing facility in South Salt Lake, dedicated to producing Co-Primers oligonucleotides, the Co-Dx PCR Pro instrument, and test cups for the new Co-Dx PCR platform.
• Capital expenditures totaled approximately $641,065 over the 12 months ending February 2023.
• The company is prioritizing its capital towards the advancement and commercialization of its Co-Dx PCR platform and associated diagnostic tests.