SALT LAKE CITY, Feb. 9, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (OTC: 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 will participate in an exhibition at the upcoming World Health Expo Labs Dubai ("WHX Labs"), taking place February 10–13, 2026, at the Dubai World Trade Centre. World Health Expo Labs Dubai, formerly Medlab Middle East, is a multi-day international exhibition that c ...

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]

Core Viewpoint - Co-Diagnostics, Inc. has conducted an in silico analysis of its Logix Smart ABC test, confirming its effectiveness against the influenza A H3N2 subclade K, which is significant due to the current flu season and vaccine mismatch [1][2][3]. Group 1: Company Developments - The Logix Smart ABC test has shown high homology against 3,900 influenza sequences, indicating comparable reactivity against the H3N2 subclade K [1]. - The test received CE-marking in November 2020 for the simultaneous detection of influenza A, influenza B, and SARS-CoV-2, with no concerns regarding sensitivity from emerging H3N2 strains [3]. - In November 2025, the company initiated clinical performance testing for a new PCR Flu A/B, COVID-19, RSV point-of-care multiplex test, aimed at FDA 510(k) clearance [4]. Group 2: Industry Context - The World Health Organization reports that seasonal influenza leads to approximately 3–5 million severe illness cases and 290,000–650,000 respiratory fatalities annually [2]. - The current flu vaccine is mismatched with the H3N2 subclade K, which has limited natural immunity in communities, raising concerns about higher hospitalization and death rates [2]. - Preliminary data indicates that countries like Japan and the UK are experiencing earlier flu seasons in 2025, following a record flu season in Australia [2].

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]