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Co-Diagnostics Launches Integrated Cloud and Mobile Infrastructure in India

Key Takeaway: Co-Diagnostics, Inc. has launched an integrated cloud infrastructure in India to support ongoing clinical studies for its tuberculosis test. This infrastructure allows for secure data management and mobile-based test analysis, enhancing decentralized testing capabilities. The initiative is partly funded by the Gates Foundation and aims to replicate the model in other markets. However, the Co-Dx PCR platform is still subject to FDA review and not available for sale.

Market Sentiment Analysis

POSITIVE FACTORS

  • Launch of integrated cloud infrastructure in India enhances clinical studies.
  • Supports secure data management and compliance with local regulations.
  • Mobile-based test analysis allows for decentralized testing capabilities.
  • Funding from the Gates Foundation aids in deployment efforts.

CONCERNS & RISKS

  • The Co-Dx PCR platform is not yet cleared or authorized by the FDA.
  • Risks associated with market demand and public health conditions may change.
  • Challenges in successfully completing clinical studies for TB tests in India.
  • Dependence on third parties for marketing and distribution may impact success.

Full Press Release Details

Localized cloud environment is designed to support ongoing clinical studies and establish the digital foundation for future data commercialization strategies
SALT LAKE CITY, Sept. 3, 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 the launch of its integrated cloud infrastructure in India. The deployment is intended to support the Company's ongoing clinical studies for its point-of-care Mycobacterium tuberculosis (MTB) test while establishing the digital foundation for future deployment of the Co-Dx ® PCR platform* throughout the country.
The localized cloud infrastructure in India supports secure data management and is designed to support compliance with applicable data privacy and cybersecurity requirements in India. The deployment also supports mobile-based test analysis using security controls that protect the data, allowing results to be generated directly through the platform's mobile application in decentralized settings where internet connections are not available. Test data are then synchronized to the cloud when connectivity improves. The Company intends to replicate this architecture in additional markets, including the Kingdom of Saudi Arabia and South Africa.
"Launching this infrastructure in India represents an important milestone in the evolution of our platform," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "Early on in the platform's development, we realized that simply increasing access to testing wasn't enough, so we built an integrated ecosystem that combines our PCR technology, mobile application and a secure cloud infrastructure to support high-quality molecular diagnostics in decentralized settings. The platform utilizes security controls designed to protect patient information while also utilizing aggregated, anonymized data to create a long-term strategic data asset. As we continue expanding internationally, this architecture provides a scalable foundation for clinical deployment, secure data management and future public health applications."
Data generated through the platform can be securely aggregated to support public health surveillance and future analytical applications. Over time, the Company's Co-Dx Primer Ai™ platform is expected to leverage these datasets to train machine learning AI models designed to enhance disease monitoring and improve outbreak prediction, while the Company also explores commercialization strategies for the anonymized data in support of public health and other uses.
The India deployment, supported in part by funding from the Gates Foundation, includes samples being processed on the PCR Pro ® instrument with analysis conducted directly on a mobile device, and results securely synchronized to the localized cloud environment.
*The Co-Dx PCR platform (including the PCR Home ®, PCR Pro ®, mobile app, and all associated tests) has not been cleared or authorized by the FDA, 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 the Company's ability to leverage its integrated cloud infrastructure and Co-Dx Primer Ai platform to support ongoing clinical studies, public health surveillance, and future analytical capabilities; the Company's plans to expand and replicate its integrated cloud infrastructure and related digital platform capabilities in additional international markets, including the Kingdom of Saudi Arabia and South Africa; the anticipated benefits of the Company's localized cloud architecture; the Company's ability to aggregate, anonymize, use and potentially commercialize data generated through the platform; and the Company's expectations regarding future commercialization of the Co-Dx PCR platform. 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 or its joint venture's ability to successfully complete clinical studies for a TB test in India; risks related to the Company's or its joint venture's ability to commercialize the platform in strategically important markets, including risks that distribution partners may not successfully market, promote, or sell the Company's products; risks associated with the successful deployment, operation, security, and scalability of the Company's cloud infrastructure and digital platform; risks relating to the Company's ability to lawfully aggregate, anonymize, use and commercialize data generated through the platform; 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 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 technologies; 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.

Frequently Asked Questions

What is the purpose of Co-Diagnostics' cloud infrastructure in India?

The cloud infrastructure supports ongoing clinical studies for tuberculosis testing and secure data management.

How does the mobile application enhance testing capabilities?

The mobile app allows for decentralized test analysis, generating results even without internet access.

What funding supports the deployment in India?

The deployment is partially funded by the Gates Foundation.

Is the Co-Dx PCR platform authorized for sale?

No, the Co-Dx PCR platform is not yet cleared or authorized by the FDA.

What are the future plans for the cloud infrastructure?

Co-Diagnostics plans to replicate the cloud infrastructure in markets like Saudi Arabia and South Africa.

Last updated: Sep 3, 2026