Co-Diagnostics to Participate in Global Health Events During UN General Assembly Week

Co-Diagnostics links UN General Assembly health engagement with ongoing TB studies in India and a recent U.S. FDA submission.

Rhea-AI Summary

Co-Diagnostics (CODX) will participate in two global health events during UN General Assembly week in New York.

The company will attend a UNOPS-hosted partnerships reception on September 23, 2026, and join the September 25 side event “TB Today. Disease X Tomorrow. Let’s Prepare for the Next Respiratory Pandemic,” focused on tuberculosis and future respiratory threats. Co-Dx is advancing its molecular diagnostics platform, with clinical performance studies of the Co-Dx™ PCR MTB tuberculosis test underway in India via joint venture CoSara. In the United States, Co-Dx submitted a 510(k) and concurrent CLIA Waiver application in August 2026 for its Co-Dx™ PCR Flu A/B & RSV test on the Co-Dx PCR Pro® instrument. The platform has not yet been cleared or authorized and is not available for sale.

Positive

• 510(k) and CLIA waiver applications submitted in August 2026 for Co-Dx PCR Flu A/B & RSV test on PCR Pro
• Clinical performance studies underway in India for the Co-Dx™ PCR MTB tuberculosis test via CoSara joint venture

Negative

• Co-Dx PCR platform not yet cleared or authorized by FDA, subject to review, and not available for sale

Key Terms

510(k) premarket notification, clia waiver by application, pcr

3 terms

510(k) premarket notification regulatory

"submitted a 510(k) premarket notification"

A 510(k) premarket notification is a regulatory submission to the U.S. Food and Drug Administration that shows a new medical device is as safe and effective as an existing, legally marketed device. Think of it like demonstrating your new model performs like a trusted older model so it can be sold; for investors, 510(k) clearance is a key hurdle that affects how quickly a device can reach market, development cost, and the level of regulatory risk in a medical-device investment.

clia waiver by application regulatory

"together with a concurrent CLIA Waiver by Application"

A CLIA waiver by application is the regulatory process where a test maker submits data to U.S. health regulators to show their diagnostic test is simple to use and poses minimal risk of incorrect results, so it can be performed outside specialized clinical labs (for example in doctors’ offices, pharmacies, or at home). For investors, waiver approval is like a retail permit: it broadens where a test can be sold and used, affecting potential market size, distribution channels, and revenue prospects.

pcr technical

"Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test"

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.

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Events Bring Together Global Health Leaders to Examine Tuberculosis and Preparedness for the Next Respiratory Pandemic

SALT LAKE CITY, Sept. 23, 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 Seth Egan, Chief Commercialization Officer, will represent the Company at two global health events during the 81st Session of the United Nations General Assembly in New York City:

• UNOPS Hosted Partnerships Reception – September 23, 2026: The Company will attend a reception, convened by UN Under-Secretary-General and UNOPS Executive Director Jorge Moreira da Silva, that brings together UNOPS leadership with executives and board members from across its hosted partnerships, including the Stop TB Partnership.
  
  
• "TB Today. Disease X Tomorrow. Let's Prepare for the Next Respiratory Pandemic" – September 25, 2026: Co-Dx will participate in this side event of the UN High-Level Meeting on Pandemic Prevention, Preparedness and Response ("PPPR"), convened by Indonesia's Ministry of Health, Japan's Ministry of Health, Labour and Welfare, and the Stop TB Partnership. The discussion will examine how lessons from the global tuberculosis response can help strengthen preparedness for future respiratory pandemics.

Co-Dx's participation comes as the Company continues to advance its molecular diagnostics platform across tuberculosis and other respiratory infections. In India, clinical performance studies of the Co-Dx™ PCR MTB test are currently underway through the Company's joint venture, CoSara Diagnostics Pvt. Ltd. ("CoSara"). In the United States, Co-Dx submitted a 510(k) premarket notification, together with a concurrent CLIA Waiver by Application, to the U.S. Food and Drug Administration ("FDA") in August 2026 for its Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument*.

Earlier this year, the World Health Organization issued its first recommendations supporting near-point-of-care molecular diagnostics and tongue-swab sampling to expand access to tuberculosis testing, approaches that align with the decentralized testing model the Co-Dx PCR platform was developed to support.

*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 participate meaningfully in international public health forums, including the UNOPS Hosted Partnerships Reception and the UNHLM on PPPR side event; the Company's or its joint venture's ability to successfully advance and complete clinical performance studies of the Co-Dx™ PCR MTB test and obtain regulatory clearance in India or elsewhere; the Company's ability to obtain FDA clearance of, or a CLIA waiver for, the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test; the Company's ability to develop the Co-Dx PCR platform to support decentralized testing; 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 advance and complete clinical performance studies of the Co-Dx™ PCR MTB test, including whether such studies will support regulatory submissions or commercialization; risks that the FDA may not grant clearance or a CLIA waiver for the Co-Dx™ PCR Flu A/B & RSV test, or may require additional data or a longer review period than anticipated; risks related to the Company's ability to successfully develop and validate the Co-Dx PCR platform for decentralized testing applications; 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 that either event or similar engagements may not result in any commercial, regulatory or other benefit to the Company; 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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Which UN General Assembly week events will Co-Diagnostics take part in and when?

Co-Diagnostics will attend the UNOPS Hosted Partnerships Reception on September 23, 2026, convened by UN Under-Secretary-General and UNOPS Executive Director Jorge Moreira da Silva. It will also participate on September 25, 2026, in the side event “TB Today. Disease X Tomorrow. Let’s Prepare for the Next Respiratory Pandemic,” held alongside the UN High-Level Meeting on Pandemic Prevention, Preparedness and Response.

What product development activities is Co-Diagnostics pursuing in tuberculosis and respiratory infections?

Co-Diagnostics is advancing its molecular diagnostics platform in tuberculosis and other respiratory infections. Clinical performance studies of the Co-Dx™ PCR MTB test for tuberculosis are ongoing in India through its joint venture CoSara Diagnostics Pvt. Ltd. In the United States, the company has submitted a 510(k) premarket notification and concurrent CLIA Waiver by Application for the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument.

How do recent World Health Organization recommendations relate to Co-Diagnostics’ platform?

Earlier in 2026, the World Health Organization issued its first recommendations supporting near-point-of-care molecular diagnostics and tongue-swab sampling to expand access to tuberculosis testing. Co-Diagnostics states that these approaches align with the decentralized testing model that the Co-Dx PCR platform was developed to support.

What is the current regulatory and commercial status of the Co-Dx PCR platform?

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