Company and CoSara believe that ISO certification is a critical component of the regulatory requirements for clearance of new platform *The Co-Dx PCR platform (including the PCR Homeâ"¢, PCR Proâ"¢, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. About Co-Diagnostics, Inc.: Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics tec ...

Core Insights - Co-Diagnostics, Inc. announced that its Indian joint venture, CoSara Diagnostics Pvt. Ltd., is enhancing its distributor network across India and participated in two regional conferences to promote its diagnostic products [1][2]. Group 1: Company Developments - CoSara is expanding its distributor base, currently having over 40 distributors in India, and introduced its SARAGENE® diagnostic products at recent conferences [2]. - The company is preparing to assist in clinical performance studies for the Co-Dx PCR Mycobacterium Tuberculosis (MTB) Test and will manufacture the PCR Pro™ instrument and MTB test cups in alignment with the "Make in India" initiative [3]. Group 2: Events and Participation - CoSara exhibited at the 44th Gujarat Association of Pathologists & Microbiologists (GAPM) conference on January 10-11 and also participated in the 13th Association of Clinical Laboratory Analysts & Practitioners (ACLAP) conference in Maharashtra during the same period [3]. Group 3: Product Information - The Co-Dx PCR platform, which includes the PCR Home™, PCR Pro™, and associated tests, is currently under review by the FDA and is not yet available for sale [4].

Core Insights - CoDiagnostics (CODX) has received a patent from the Australian Patent Office for its Co-Dx PCR platform, marking a significant milestone for its point-of-care technology [1][8]. Company Developments - The patent strengthens CODX's long-term commercialization strategy by securing intellectual property in Australia, a region that could become a vital market in the future [2][10]. - The Co-Dx PCR platform is still under regulatory review and not yet available for sale, but the patent enhances CODX's position for future commercialization and partnership opportunities [11][4]. - The patent covers the PCR Pro instrument and proprietary test cups, which are designed for high-quality PCR testing in decentralized settings [9][8]. Market Performance - Following the patent announcement, CODX shares fell by 21.1% at the market close, with a total decline of 35.5% over the past six months, contrasting with a 6.2% growth in the industry and a 14.1% gain in the S&P 500 during the same period [3][6]. Industry Outlook - The global molecular diagnostics market is projected to grow from an estimated $18.85 billion in 2025 to $25.59 billion by 2033, with a compound annual growth rate (CAGR) of 4.06% from 2026 to 2033 [12]. - Key drivers for this growth include technological advancements, an aging population, and increasing demand for precise genetic testing solutions [12].

Core Viewpoint - Co-Diagnostics (CODX) has announced a reverse stock split at a ratio of 1-for-30 shares to comply with Nasdaq's minimum bid price requirement [1] Group 1: Reverse Stock Split Details - The reverse stock split will take effect at 12:01 a.m. ET on January 2, 2026 [1] - Co-Dx's common stock will continue to trade on The Nasdaq Capital Market under the symbol "CODX" and will begin trading on a split-adjusted basis on the same date [1] - The new CUSIP number for Co-Dx's common stock after the reverse stock split will be 189763 204 [1] Group 2: Compliance and Listing - The purpose of the reverse stock split is to enable Co-Diagnostics to regain compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market [1]

SALT LAKE CITY, Dec. 17, 2025 /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 performed an in silico analysis of the Co-Primers® used in its Logix Smart® ABC test* for the detection of influenza A, influenza B and COVID-19. The analysis showed a high homology against 3,900 influenza sequences, confirming comparable reactivity of the p ...

Core Insights - Co-Diagnostics, Inc. announced ongoing Phase II preclinical study data for its Co-Dx PCR MTB and HPV tests, supporting advancement to clinical performance testing [1][4] Group 1: Co-Dx PCR MTB Test - CoSara Diagnostics Pvt. Ltd. is supporting Phase II preclinical studies for the Co-Dx PCR MTB test, which evaluates Mycobacterium tuberculosis detection [2] - Phase I studies included 354 clinical specimens, while Phase II has evaluated 211 sputum specimens to establish concordance with other tests [2] Group 2: Co-Dx PCR HPV Test - The Phase I preclinical studies for the 8-type HPV multiplex test involved 286 clinical specimens to validate the Co-Primers® test chemistry [3] - Phase II has analyzed 53 specimens to facilitate the detection of three high-risk HPV genotypes, with ongoing refinement of the application algorithm [3] Group 3: Upcoming Events and Engagement - CoSara will host a booth at VIROCON 2025, providing an opportunity for attendees to learn more about the TB and HPV tests on the Co-Dx PCR platform [4] - VIROCON 2025 is organized by the India Council of Medical Research - National Institute of Virology, focusing on innovations in public health related to viral epidemics [5]

Core Insights - Co-Diagnostics, Inc. (CODX) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3] - The Zacks rating system is based on changes in earnings estimates, providing a more objective measure for investors compared to traditional Wall Street ratings [2][9] Earnings Estimates and Stock Performance - The correlation between changes in earnings estimates and stock price movements is strong, influenced by institutional investors who adjust their valuations based on these estimates [4][5] - CoDiagnostics is expected to earn -$0.72 per share for the fiscal year ending December 2025, with no year-over-year change, but the Zacks Consensus Estimate has increased by 8.9% over the past three months [8] Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7] - The upgrade of CoDiagnostics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10]

Core Insights - Co-Diagnostics, Inc. reported a quarterly loss of $0.16 per share, better than the Zacks Consensus Estimate of a loss of $0.19, and an improvement from a loss of $0.32 per share a year ago, resulting in an earnings surprise of +15.79% [1] - The company posted revenues of $0.15 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 51.67%, and a decline from $0.64 million in the same quarter last year [2] - Co-Diagnostics shares have decreased by approximately 47.2% year-to-date, contrasting with the S&P 500's gain of 16.5% [3] Earnings Outlook - The earnings outlook for Co-Diagnostics is uncertain, with current consensus EPS estimates at -$0.16 on $0.3 million in revenues for the upcoming quarter and -$0.79 on $0.81 million in revenues for the current fiscal year [7] - The estimate revisions trend for Co-Diagnostics was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical Services industry, to which Co-Diagnostics belongs, is currently ranked in the bottom 39% of over 250 Zacks industries, suggesting potential challenges for stock performance [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact investor sentiment [5]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $0.1 million, a decrease from $0.6 million in the same period last year, with all revenue recognized coming from product sales in the current quarter [19] - Total operating expenses decreased to $7.1 million in Q3 2025 from $10.6 million in Q3 2024, reflecting a focus on operational efficiency [19] - Net loss for Q3 2025 was $5.9 million, or a loss of $0.16 per fully diluted share, compared to a $9.7 million loss, or $0.32 per fully diluted share in the same period last year [20] - Adjusted EBITDA was a loss of $6.3 million in Q3 2025, improved from a loss of $8.8 million in Q3 2024 [21] - The company ended the quarter with $11.4 million in cash, cash equivalents, and marketable investment securities [21] Business Line Data and Key Metrics Changes - The company is focused on four main growth pillars: strategic alternatives for the Indian joint venture, international expansion through the Comera joint venture, innovation via the AI business unit, and clinical evaluations for new tests [4][5] - The upcoming upper respiratory multiplex test is designed to detect Flu A, Flu B, COVID-19, and RSV, marking a significant addition to the product portfolio [13][14] Market Data and Key Metrics Changes - The global market size for infectious disease diagnostics is expected to grow to $73.56 billion by 2030, with North America being the largest geographical market [15] - The respiratory infectious disease testing market in the Middle East is expanding, driven by investments in public health initiatives [15] Company Strategy and Development Direction - The company is pursuing a SPAC transaction for its Indian joint venture, Cosera Diagnostics, to unlock value and support long-term funding strategies [5][7] - The Comera joint venture aims to localize the CODEX PCR platform in the Middle East and North Africa, enhancing the company's international footprint [9][10] - The AI business unit is focused on developing AI-powered diagnostics and improving operational efficiency, positioning the company for growth in healthcare technology [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about multiple commercial launches expected in 2026 and ongoing development within the test pipeline [22] - The company is strategically allocating resources to support development priorities and regulatory submissions [21][22] Other Important Information - The company closed two strategic direct offerings totaling gross proceeds of $10.8 million, strengthening its balance sheet [17] - The RADxTech grant from the NIH supports the clinical evaluation of the upper respiratory multiplex test, underscoring its public health relevance [13][15] Q&A Session Summary Question: Performance of Cosera and Comera - Management is pleased with the performance of both Cosera and Comera, highlighting the established footprint in India and the strategic importance of the joint venture in Saudi Arabia [25][26][28] Question: Interaction of Cosera spin-out with MTB and HPV programs - Management indicated a concrete plan in India to address tuberculosis and HPV, emphasizing the need for accessible and accurate diagnostics [33][35] Question: Affordability of PCR Pro - The company aims to produce the PCR Pro at a price point of $300-$500, leveraging a fresh approach in engineering and the use of co-primers for multiplexing [37][39] Question: Relevance of products for the Comera market - All current pipeline products are deemed relevant for the Comera market, particularly the upper respiratory multiplex test [40]

Core Insights - Co-Diagnostics is entering a critical phase of growth, focusing on operational, financial, and strategic resilience to create lasting shareholder value [1][4][20] Financial Performance - For Q3 2025, total revenue was $100,000, down from $600,000 in the same period last year, with all revenue coming from product sales [23] - Total operating expenses decreased to $7.1 million from $10.6 million year-over-year, reflecting improved operational efficiency [23] - Net loss for Q3 2025 was $5.9 million, or $0.16 per fully diluted share, compared to a loss of $9.7 million, or $0.32 per share, in Q3 2024 [24] - Adjusted EBITDA loss improved to $300,000 from a loss of $8.8 million in the prior year [24] - The company ended the quarter with $11.4 million in cash and equivalents, indicating a focus on maintaining a healthy balance sheet [24] Strategic Initiatives - The company is engaging Maxim Group to explore strategic alternatives for its Indian joint venture, Kocera Diagnostics, potentially including a merger with a SPAC [4][6] - The Comira joint venture with Arabian Eagle aims to expand Co-Diagnostics' presence in Saudi Arabia and 18 additional MENA nations [4][9] - The AI business unit is focused on enhancing operational efficiency and developing proprietary AI-powered diagnostics [11][12] - Upcoming clinical evaluations for an upper respiratory multiplex test will validate the company's scientific leadership and support regulatory submissions [14][16] Market Expansion - The Comira joint venture will localize the Kodiak PCR platform across the MENA region, with a focus on manufacturing and distribution [9][10] - The partnership aligns with Saudi Vision 2030, emphasizing technology localization and healthcare innovation [10] - The company is also advancing its tuberculosis and HPV multiplex tests, supported by grants from the Bill and Melinda Gates Foundation, to address unmet needs in international markets [19][20] Future Outlook - Co-Diagnostics anticipates multiple commercial launches in 2026, supported by a robust development pipeline and strategic resource allocation [26] - The company is committed to optimizing its operating footprint to drive efficiency gains and cost savings [24][26] - The introduction of competitively priced diagnostics is expected to position Co-Diagnostics as a leader in point-of-care PCR diagnostics [20][36]