Co-Diagnostics Launches Integrated Cloud and Mobile Infrastructure in India

Co-Diagnostics is building a localized cloud and mobile data backbone in India to feed future public health, AI and commercialization efforts.

Rhea-AI Summary

Co-Diagnostics (CODX) launched an integrated, localized cloud and mobile infrastructure in India on September 3, 2026 to support clinical studies of its point-of-care Mycobacterium tuberculosis (MTB) test and future deployment of the Co-Dx PCR platform*

The India-based cloud is designed for secure data management and compliance with local privacy and cybersecurity requirements. It enables mobile test analysis in decentralized, low-connectivity settings, syncing results when connections are restored. The company plans to replicate this architecture in Saudi Arabia and South Africa and to use aggregated, anonymized data for public health surveillance, AI-driven outbreak prediction and future data commercialization strategies, supported partly by Gates Foundation funding.

Positive

• Launch of localized cloud in India to support MTB clinical studies and future Co-Dx PCR platform deployment
• Mobile-based test analysis enabled in decentralized settings with offline operation and secure synchronization to the cloud
• Architecture planned for replication in additional markets, including the Kingdom of Saudi Arabia and South Africa
• Aggregated, anonymized data intended to support public health surveillance and future AI models for disease monitoring
• Gates Foundation funding supports the India deployment using the PCR Pro instrument and mobile-based analysis

Negative

• Co-Dx PCR platform not yet cleared or authorized by the FDA or other regulators and is not available for sale

News Explained

The India infrastructure has launched, but the underlying Co-Dx PCR platform remains subject to FDA and other regulatory review and is not yet cleared, authorized, or available for sale.

Market Context

The August 6 FDA submission was followed by a -5.96% 24-hour move, adding a relevant precedent for t...

Analysis

The August 6 FDA submission was followed by a -5.96% 24-hour move, adding a relevant precedent for this platform update. The effective S-3 resale registration remains a dilution-related risk to monitor.

Key Figures

Announcement date: Sept. 3, 2026

1 metrics

Announcement date Sept. 3, 2026 India infrastructure launch

Historical Context

5 past events · Latest: Sep 01 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Sep 01	International installation	Positive	-4.0%	First international Vector Smart installation at an overseas U.S. Air Force base
Aug 18	Regulatory submission update	Positive	-6.0%	Roundtable participation and FDA 510(k) submission for respiratory multiplex test
Aug 13	Second-quarter earnings	Negative	-6.0%	Minimal revenue, net loss and lower cash despite reduced operating expenses
Aug 06	FDA submission	Positive	-6.0%	510(k) and CLIA waiver submissions supported by clinical and analytical studies
Jul 30	Earnings date announcement	Neutral	+3.3%	Company scheduled second-quarter results release and webcast for August 13

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive expansion and regulatory announcements were followed by negative 24-hour reactions, while the earnings-related event also declined.

Key Terms

mycobacterium tuberculosis, point-of-care, pcr

3 terms

mycobacterium tuberculosis medical

"ongoing clinical studies for its point-of-care Mycobacterium tuberculosis (MTB) test"

Mycobacterium tuberculosis is the bacterium that causes tuberculosis (TB), a contagious lung infection that can become chronic and hard to treat. Think of it as a stubborn weed that can survive in the body and, in some cases, resist standard treatments; this matters to investors because the threat of drug-resistant strains, new diagnostics, vaccines, or treatments can drive demand, regulatory scrutiny, public health spending, and the commercial prospects of healthcare companies.

point-of-care medical

"ongoing clinical studies for its point-of-care Mycobacterium tuberculosis (MTB) test"

"Point-of-care" refers to the location where immediate decision-making or actions happen, often involving the direct delivery of services or results. In healthcare, it describes tests or treatments performed directly at the patient's side, rather than in a distant laboratory. For investors, understanding "point-of-care" highlights the convenience, speed, and potential growth opportunities of services or products that bring solutions directly to the user or patient.

pcr technical

"future deployment of the Co-Dx® PCR platform throughout the country"

PCR (polymerase chain reaction) is a laboratory method that makes many copies of a tiny piece of genetic material (DNA or RNA) so scientists can detect and study it reliably — think of photocopying a faint, tiny note until the words are easy to read. For investors, PCR matters because it underpins diagnostic tests, drug development, and biotech tools whose sales, regulatory approvals, and real-world use can materially affect company revenues and market perceptions during health events or product launches.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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.

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SOURCE Co-Diagnostics

FAQ

What did Co-Diagnostics (CODX) announce about its cloud infrastructure in India?

Co-Diagnostics announced the launch of an integrated, localized cloud and mobile infrastructure in India to support ongoing clinical studies of its point-of-care MTB test and to create the digital foundation for future deployment of the Co-Dx PCR platform throughout the country.

How will the new India cloud platform support Co-Diagnostics' tuberculosis test (CODX)?

The India cloud platform supports Co-Diagnostics’ ongoing clinical studies for its Mycobacterium tuberculosis (MTB) point-of-care test by managing test data securely, enabling mobile-based analysis in decentralized settings and synchronizing results to a localized cloud that is designed to meet Indian data privacy and cybersecurity requirements.

How does the Co-Dx infrastructure handle mobile and offline test analysis in India for CODX?

The Co-Dx infrastructure allows test analysis directly on a mobile device in decentralized locations where internet access is unavailable. Security controls protect the data, and results are stored locally and then synchronized to the localized cloud environment once connectivity improves, supporting secure, flexible field use.

Which future markets will use Co-Diagnostics' new cloud and mobile architecture (CODX)?

Co-Diagnostics intends to replicate the India cloud and mobile architecture in additional markets, specifically including the Kingdom of Saudi Arabia and South Africa. The company presents this design as a scalable foundation for international clinical deployment and secure data management across multiple geographies.

How will Co-Diagnostics (CODX) use data and AI from its India deployment?

Data generated through the platform can be securely aggregated and anonymized to support public health surveillance and analytical applications. Over time, the Co-Dx Primer Ai platform is expected to use these datasets to train AI models aimed at enhancing disease monitoring and improving outbreak prediction, with potential data commercialization.

Is the Co-Dx PCR platform from Co-Diagnostics (CODX) FDA cleared or available for sale?

The Co-Dx PCR platform, including PCR Home, PCR Pro, the mobile app and associated tests, has not been cleared or authorized by the FDA, remains subject to review by the FDA and/or other regulatory bodies, and is not yet available for sale.

Who is helping fund Co-Diagnostics' India cloud and mobile deployment (CODX)?

The India deployment is supported in part by funding from the Gates Foundation. Samples are processed on the PCR Pro instrument, analysis is performed directly on a mobile device, and results are then securely synchronized to the localized Indian cloud environment as part of this funded effort.