Co-Diagnostics, Inc. Signs Strategic MOU with Partner in Kingdom of Saudi Arabia to Introduce Co-Dx™ PCR Platform to Middle East

Rhea-AI Summary

Co-Diagnostics (NASDAQ:CODX) has signed a strategic Memorandum of Understanding (MOU) with a partner in Saudi Arabia to establish a joint venture for manufacturing and distributing its Co-Dx™ PCR platform across the Middle East and North Africa (MENA) region.

The planned JV aligns with Saudi Arabia's Vision 2030 initiatives and follows a similar model to CODX's Indian joint venture, CoSara Diagnostics. The Saudi partner will provide local operational support, infrastructure, personnel, and regulatory expertise throughout the MENA region. Saudi Arabia represents one of the largest international markets for CODX's Logix Smart® tests.

The Co-Dx PCR platform, including PCR Home™ and PCR Pro™, is currently pending regulatory review and is not yet available for sale.

Positive

• Strategic expansion into MENA region through joint venture in Saudi Arabia
• Potential access to Saudi government incentives through Vision 2030 alignment
• Leveraging established presence in one of company's largest international markets
• Local partner providing critical operational and regulatory expertise

Negative

• Co-Dx PCR platform still pending FDA and regulatory approvals
• Agreement is preliminary (MOU stage) with final terms yet to be determined

The Memorandum of Understanding includes the formation of a Joint Venture in the Kingdom of Saudi Arabia for manufacturing and distribution of the Company's upcoming Co-Dx™ PCR platform and other Co-Dx IP

SALT LAKE CITY, Sept. 16, 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 signed a strategic Memorandum of Understanding (MOU) with a regional manufacturing and distribution company located in the Kingdom of Saudi Arabia (KSA), to explore a joint venture (JV) that would be granted a license to develop, manufacture, and sell Co-Dx intellectual property throughout the Middle East and North Africa (MENA), including the Company's upcoming Co-Dx™ PCR point-of-care platform.*

KSA has been one of largest international markets for the Company's Logix Smart® tests. The JV's mission of engaging in research, development, manufacturing, assembly, distribution and commercialization of Co-Dx products would be anticipated to be aligned with the initiatives outlined in KSA's Vision 2030, which the Company believes would allow the JV to be eligible to benefit from applicable KSA government incentives.

According to the MOU, the KSA partner company in the JV would contribute local operational support, access to infrastructure, personnel, regulatory expertise, and other mission-critical resources in furtherance of the JV's objectives across MENA countries, similar to the Company's operations in India through its Indian JV, CoSara Diagnostics Pvt Ltd.

"We are pleased to announce this Memorandum to formalize the structure, scope and mission of an anticipated joint venture in KSA, which we believe illustrates our dedication to increasing the accessibility of high-quality PCR diagnostics on a global scale," remarked Company CEO Dwight Egan. "We look forward to the ongoing discussions with the KSA partner as we explore ways to expand our reach across this important region, for both our upcoming Co-Dx PCR platform as well as our existing suite of lab-based PCR diagnostic products."

*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 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 technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of 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 and to identify genetic markers for use in applications other than infectious disease.

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 may include, but are not limited to, statements regarding the anticipated 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, 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, 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 numerous 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 execution of definitive agreements, the receipt of any required regulatory approvals, the Company's ability to successfully establish and operate the joint venture, the performance and acceptance of the Company's products, changes in government policies or incentives, competition, and other risks described 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 is the purpose of Co-Diagnostics' (CODX) MOU with Saudi Arabia?

The MOU aims to establish a joint venture in Saudi Arabia for manufacturing and distributing Co-Dx's PCR platform and other diagnostic products throughout the Middle East and North Africa region.

What will the Saudi partner contribute to CODX's joint venture?

The Saudi partner will provide local operational support, infrastructure, personnel, and regulatory expertise for operations across MENA countries.

Is Co-Diagnostics' PCR platform currently available in Saudi Arabia?

No, the Co-Dx PCR platform (including PCR Home™ and PCR Pro™) is still subject to FDA and regulatory review and is not yet available for sale.

How does the Saudi Arabia joint venture compare to CODX's other international operations?

The Saudi Arabia joint venture follows a similar model to CODX's existing Indian joint venture, CoSara Diagnostics Pvt Ltd.

What is the significance of Saudi Arabia for Co-Diagnostics?

Saudi Arabia represents one of the largest international markets for Co-Diagnostics' Logix Smart® tests.