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Co-Diagnostics Advances Latin American Commercialization Strategy for Co-Dx™ PCR Pro® with Mexico Distributor Agreement

Key Takeaway: Co-Diagnostics has entered an exclusive distribution agreement with a partner in Mexico to advance the commercialization of its Co-Dx PCR Pro platform. This agreement aims to expand the company's presence in Latin America and support the introduction of various molecular diagnostics products. The partnership has previously generated significant revenue and played a crucial role during the COVID-19 pandemic.

Market Sentiment Analysis

POSITIVE FACTORS

  • Exclusive distribution agreement enhances market presence in Mexico.
  • Potential for a broader menu of molecular diagnostics products.
  • Strong revenue generation from existing partnerships.

CONCERNS & RISKS

  • Commercialization is subject to regulatory review and authorization.
  • Dependence on distributors for successful market introduction.
  • Potential risks related to changing market demand and public health conditions.

Full Press Release Details

Longstanding distribution partner to support future deployment of Co-Dx™ PCR Pro®and expanding menu of molecular diagnostics products across a key Latin American market
SALT LAKE CITY,June 11, 2026/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 entered into an exclusive distribution agreement with its longstanding partner in Mexico for the Co-Dx™ PCR point-of-care platform*, including the PCR Pro®instrument and associated test kits, advancing the Company's strategy to expand its commercialization network and footprint in Latin America ahead of the platform's market launch, which remains subject to applicable regulatory review and authorization.
"We are pleased to continue building on our longstanding relationship in Mexico with a distributor that played an important role in the successful deployment of our molecular diagnostics products during the COVID-19 pandemic," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "As we prepare for commercialization of the Co-Dx PCR point-of-care platform, we believe this agreement positions us well to support the introduction of a broader menu of point-of-care molecular diagnostics products across Mexico, the second largest market in Latin America by population.
"Over the past several years, we have expanded our capabilities beyond COVID to include multiple infectious disease applications, including tuberculosis, HPV, mpox, H5N1, and arecently-announcedEbola assay development initiative, and we believe the flexibility and rapid response capability of our high-quality PCR technology will become increasingly important in global diagnostics markets."
The Company has generated over $18 million in revenue through sales of its Logix Smart®PCR tests and clinical lab testing equipment since 2020 with this distribution partner. The previously existing partnership was also instrumental in driving adoption of the Company's Logix Smart COVID-19 PCR test, which comprised more than 50% of all COVID-19 tests used across Mexico through 2021, according to publicly available data of COVID tests performed during that period.
The agreement establishes the distributor as having exclusive distribution rights for the Co-Dx PCR platform in Mexico, and extends the existing agreement for an additional five years.
*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 (subject to regulatory review and not currently for sale) 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 can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will," "seeks," "anticipates," and similar expressions, or the negative of these terms. Forward-looking statements in this press release include, but are not limited to, statements regarding: (i) Future deployment of the Company's expanding menu of molecular diagnostics products across key Latin American markets; (ii)The Company's plans and expectations regarding expansion of its commercialization network and footprint in Latin America and preparation for potential future commercialization of the Co-Dx PCR platform, subject to applicable regulatory review and authorization; and (iii) that the flexibility and rapid response capability of the Company's high-quality PCR technology will become increasingly important in global diagnostics markets. Such statements are subject to a number of risks and uncertainties, including, without limitation: risks that market demand or public health conditions may change; risks related to the Company's ability to successfully introduce a broader menu of point-of-care molecular diagnostics products across Mexico and potentially other parts of Latin America; risks related to the Company's dependence on distributors and other third parties, including risks that distribution partners may not successfully market, promote, or sell the Company's products;risks associated with international operations, including changing regulatory requirements, economic conditions, reimbursement environments, import/export restrictions, and foreign currency fluctuations; risks related to regulatory review by the FDA or other regulatory authorities that would be required to achieve a successful commercial launch; risks related to the performance, reliability, and market acceptance of the Co-Dx PCR platform and other Co-Dx technology; risks associated with dependence on third parties, suppliers, collaborators, and distribution partners; risks related to competition, technological change, and intellectual property protection;and other risks described from time to time in the Company's filings with the Securities and Exchange Commission ("SEC"). Actual results may differ materially from those expressed or implied in these forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements. A further description of risks and uncertainties can be found in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2026, and in its other filings with the SEC. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
SOURCE Co-Diagnostics

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Frequently Asked Questions

What is the Co-Dx PCR Pro platform?

The Co-Dx PCR Pro platform is a point-of-care molecular diagnostics system developed by Co-Diagnostics.

Who is Co-Diagnostics' distribution partner in Mexico?

Co-Diagnostics has a longstanding distribution partner in Mexico that will support the Co-Dx PCR platform.

What diseases does Co-Diagnostics test for?

Co-Diagnostics tests for various infectious diseases, including tuberculosis, HPV, and Ebola.

What regulatory approval is needed for the Co-Dx PCR platform?

The Co-Dx PCR platform requires review and authorization from the FDA and other regulatory bodies.

How much revenue has Co-Diagnostics generated since 2020?

Co-Diagnostics has generated over $18 million in revenue through its distribution partner since 2020.

Last updated: Jun 11, 2026