Co-Diagnostics Signs Definitive Agreement with Arabian Eagle in the Kingdom of Saudi Arabia to Establish CoMira Diagnostics and Localize Co-Dx™ PCR Platform Across the Middle East

Rhea-AI Summary

Co-Diagnostics (NASDAQ: CODX) signed a definitive joint venture agreement with Arabian Eagle to form CoMira Diagnostics in the Kingdom of Saudi Arabia to research, develop, manufacture, assemble, distribute, and commercialize Co-Dx technologies across KSA and 18 additional MENA countries. CoMira will pursue SFDA clearance to facilitate regional market entry and receive an exclusive license to manufacture and commercialize Co-Dx IP, including the upcoming Co-Dx PCR point-of-care platform. Infectious-disease tests slated for clinical evaluations before the end of 2025 include tuberculosis, an 8-type HPV multiplex, and a respiratory multiplex for influenza A/B, COVID-19, and RSV. The platform remains subject to regulatory review and is not yet available for sale.

Positive

• Joint venture: Definitive JV with Arabian Eagle to form CoMira in KSA
• Regional scope: Manufacturing and distribution across KSA plus 18 MENA countries
• Exclusive license: CoMira to receive exclusive rights to Co-Dx IP and upcoming platform
• Clinical timeline: Clinical evaluations for multiple infectious tests planned before end of 2025
• Regulatory route: Planned SFDA clearance intended to facilitate broader Territory entry

Negative

• Regulatory status: Co-Dx PCR platform is under review and not available for sale
• Clinical uncertainty: Key infectious-disease tests pending clinical evaluations scheduled before end of 2025

Insights

Commercial Strategy Expert

Joint venture creates localized manufacturing and exclusive regional commercial rights, expanding distribution across 19 MENA countries.

The agreement establishes CoMira Diagnostics as a Saudi‑based JV between Co-Dx and Arabian Eagle to manufacture, assemble and commercialize the Co-Dx PCR platform and existing IP across KSA and 18 other MENA countries, using an exclusive license model.

Revenue and market access depend on successful SFDA registration and facility setup led by Arabian Eagle; operational execution, local regulatory timelines, and supply‑chain buildout are key dependencies and risks.

Watch for completion of SFDA clearance and the JV’s manufacturing ramp; clinical evaluations slated to begin before the end of 2025 are immediate milestones that will affect commercial timing in the next 6–18 months.

Regulatory & Clinical Expert

Regulatory path via the SFDA is the pivotal gating item for regional rollout and clinical validation of platform tests.

The partners plan to pursue SFDA clearance first, aiming to leverage that approval for broader entry across the Territory; the JV will support regulatory registration and local compliance as core responsibilities.

Clinical evaluations for infectious‑disease assays on the upcoming Co-Dx PCR platform, including tuberculosis, an 8‑type HPV multiplex, and an upper respiratory multiplex, are scheduled to begin before the end of 2025; test performance and regulatory submissions will determine timing for commercialization.

Monitor SFDA submission status and initial clinical readouts as the primary indicators of near‑term regulatory and market progress over the next 6–12 months.

The new Saudi-based CoMira Diagnostics joint venture will be engaged in manufacturing and distribution of the Company's upcoming Co-Dx™ PCR platform and other Co-Dx IP across KSA and 18 other MENA countries

SALT LAKE CITY, Oct. 27, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has entered into a definitive agreement with Arabian Eagle Manufacturing ("Arabian Eagle"), a regional manufacturing and distribution company based in the Kingdom of Saudi Arabia ("KSA") to form a joint venture ("JV"), CoMira Diagnostics ("CoMira"), to research, develop, manufacture, assemble, distribute, and commercialize Co-Dx technologies and intellectual property, including the Company's upcoming Co-Dx™ PCR point-of-care platform*, within KSA and 18 other countries (the "Territory") throughout the Middle East and North Africa ("MENA").

CoMira's mission aligns with the key pillars of Saudi Vision 2030, supporting technology localization, industrial diversification, and healthcare innovation, as the new venture engages in research, development, manufacturing, assembly, distribution, and commercialization of Co-Dx products.

The CoMira partners also believe that initially pursuing regulatory clearance with the Saudi Food & Drug Administration ("SFDA") will directly facilitate entry into many other countries in the Territory.

Company CEO Dwight Egan commented "We are pleased to announce this agreement to establish the relationship with Arabian Eagle, our valued partners in the Middle East, as we expand the reach of our exciting healthcare innovations into a region with a large and growing market for medical devices and point-of-care diagnostics. The KSA has published the key demand drivers that underpin that anticipated growth, and we believe that our cutting-edge PCR technology, along with the scope and mission of CoMira, addresses those drivers while reinforcing our resolve to close the accessibility gap between high-quality PCR diagnostics and those who need them."

"Arabian Eagle Manufacturing is proud to partner with Co-Diagnostics in establishing a transformative platform for molecular diagnostics within the Kingdom of Saudi Arabia," remarked Ihssan Rjoob, CEO of Arabian Eagle. "This collaboration supports the goals of Saudi Arabia's Vision 2030 by advancing health security, driving technology localization, and promoting sustainable industrial growth.

"This partnership represents a compelling model for combining international innovation with strong local leadership, utilizing machine learning and AI for continuous process improvement, and delivering lasting impact across healthcare and manufacturing ecosystems," continued Mr. Rjoob.

"Most importantly, we believe that our shared mission to empower patients, clinicians, and healthcare providers with faster, more accessible and reliable diagnostic tools, will ultimately contribute to better health outcomes across the region."

The principals of Arabian Eagle ran the primary distributor in the Middle East and were instrumental in KSA being one of the largest international markets for the Company's Logix Smart® tests. According to the JV agreement, Arabian Eagle will contribute local operational and customer support, lead the manufacturing facility set-up and regulatory clearance/registration responsibilities, manage other logistics activities and ensure compliance with local industrial and commercial laws in pursuit of the JV's objectives across the Territory.

Similar to the Company's partnership in India with its existing JV, CoSara Diagnostics Pvt Ltd, Co-Dx will provide CoMira an exclusive license to use, manufacture, and commercialize the licensed IP, which will include the upcoming Co-Dx PCR platform as well as the Company's existing suite of lab-based PCR diagnostic products. Infectious disease tests on the new platform currently in preparation to begin clinical evaluations before the end of 2025 in various jurisdictions include tuberculosis, an 8-type HPV multiplex test, and an upper respiratory multiplex test for influenza A and B, COVID-19, and RSV.

Other MENA countries included in the Territory consist of Bahrain, Iraq, Jordan, Kuwait, Lebanon, Oman, Palestine, Qatar, Syria, Turkey, United Arab Emirates (UAE), Yemen, Algeria, Egypt, Libya, Morocco, Sudan and Tunisia.

*The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not currently 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 technologies. The Company's technologies are utilized for tests that are designed to detect and/or analyze nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform (subject to regulatory review and not currently for sale) and to identify genetic markers for use in applications other than infectious disease.

About Arabian Eagle Manufacturing:
Arabian Eagle Manufacturing is a Saudi-based investment and operating company focused on building high-impact industrial and healthcare ventures across the Kingdom. The company integrates artificial intelligence and automation technologies to accelerate growth, efficiency, and innovation across its projects.

Arabian Eagle Manufacturing's mission aligns with the objectives of Saudi Vision 2030, with a firm commitment to strengthening national capabilities, supporting healthcare providers with cutting-edge technologies, and enhancing the quality of care available to patients. Through regional expertise, regulatory insight, and global collaboration, the company aims to position Saudi Arabia as a leader in sustainable healthcare innovation.

Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the CoMira Diagnostics joint venture in the Kingdom of Saudi Arabia, potential licensing, development, manufacturing, distribution and commercialization of Co-Diagnostics' products, the alignment of such activities with KSA's Vision 2030 initiatives, anticipated regulatory submissions, clearances, and approvals, eligibility for government incentives, ongoing discussions with the Company's regional partner, the potential benefits of such arrangements, the availability and regulatory status of the Company's upcoming Co-Dx™ PCR platform, clearance by SFDA allowing access to other MENA countries and the Company's ability to expand access to its diagnostic technologies in the Middle East and North Africa. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in these statements, including but not limited to risks related to the negotiation and performance of definitive agreements, obtaining regulatory approvals, establishing and operating manufacturing and other local facilities, market acceptance, supply-chain or quality-system challenges, and geopolitical or economic conditions. Additional information about these and other risks is included in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. All forward-looking statements are based on current expectations and assumptions, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Please note that we disclaim any responsibility for the content of external links provided in this press release. These links are provided solely for the reader's convenience and do not constitute endorsement by the Company.

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SOURCE Co-Diagnostics

FAQ

What did Co-Diagnostics (CODX) announce about the CoMira joint venture in Saudi Arabia on October 27, 2025?

Co-Diagnostics announced a definitive JV with Arabian Eagle to form CoMira to localize manufacturing and commercialize Co-Dx IP across KSA and 18 other MENA countries.

Which countries will CoMira cover under the Co-Diagnostics (CODX) agreement?

CoMira's Territory includes KSA plus 18 MENA countries such as UAE, Egypt, Turkey, Qatar, Kuwait, Bahrain, Oman, Jordan, Lebanon, and others listed in the agreement.

How will the CoMira JV affect CODX's regulatory pathway and market entry in the Middle East?

CoMira will pursue SFDA clearance in KSA, which the partners expect to facilitate entry into many other countries in the Territory.

What diagnostic tests will Co-Diagnostics (CODX) seek to evaluate on the Co-Dx PCR platform before end of 2025?

Planned clinical evaluations include tuberculosis, an 8-type HPV multiplex, and an upper respiratory multiplex for influenza A/B, COVID-19, and RSV.

Will the Co-Dx PCR platform be immediately available for sale in the region after the JV announcement?

No; the Co-Dx PCR platform is subject to regulatory review and is not currently available for sale.

What operational roles will Arabian Eagle perform in the CoMira joint venture with CODX?

Arabian Eagle will lead manufacturing facility set-up, local operations and customer support, regulatory clearance/registration, logistics, and compliance across the Territory.