Co-Diagnostics Participates in Medical Devices and Innovations Roundtable Media Event

Rhea-AI Summary

Co-Diagnostics (Nasdaq: CODX)/b) reported that Chief Commercialization Officer Seth Egan participated in the Salt Lake Business Journal's 2026 Medical Devices and Innovation Roundtable on August 13 in Salt Lake City, Utah. The 90-minute session, moderated by law firm Maschoff Brennen, gathered industry stakeholders to discuss innovation, AI’s impact on medical devices, data interoperability and commercialization strategies.Co-Diagnostics also highlighted its recent 510(k) premarket notification submission to the FDA for the Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro platform. The point-of-care Co-Dx PCR platform, conceived during the pandemic, remains under FDA and other regulatory review and is not yet cleared or available for sale.

Market Context

An effective S-3 resale registration dated May 28, 2026 adds financing context to this roundtable ap...

Analysis

An effective S-3 resale registration dated May 28, 2026 adds financing context to this roundtable appearance: selling stockholders may resell registered securities, while the company receives no resale proceeds. FDA review remains a stated constraint.

Key Figures

Event Date: August 13, 2026 Event Duration: 90 minutes Premarket Notification: 510(k)

3 metrics

Event Date August 13, 2026 Medical Devices and Innovation Roundtable

Event Duration 90 minutes Medical Devices and Innovation Roundtable

Premarket Notification 510(k) Co-Dx PCR Flu A/B & RSV test submission to the FDA

Historical Context

5 past events · Latest: Aug 13 (Negative)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Aug 13	2Q26 earnings report	Negative	-6.0%	Revenue was $0.17 million; net loss was $6.3 million and cash was $3.6 million.
Aug 06	510(k) submission	Positive	-6.0%	FDA submission was supported by clinical and analytical studies; the platform remained unavailable for sale.
Jul 30	Earnings date notice	Neutral	+3.3%	The company scheduled second-quarter results and a webcast for August 13.
Jul 28	Ebola test partnership	Positive	-30.9%	CoSara supplied 200 Ebola test kits for analytical studies.
Jul 22	TB clinical partnership	Positive	-3.4%	CoSara initiated clinical studies in India for tuberculosis testing.

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

Pattern Detected

Recent positive or development-related announcements were frequently followed by negative price reactions.

Key Terms

molecular diagnostics, 510(k) premarket notification, point-of-care, data interoperability

4 terms

molecular diagnostics medical

"Co-Diagnostics, Inc. ... a molecular diagnostics company with a unique, patented platform"

Molecular diagnostics are laboratory tests that look for specific molecules — such as genes, pieces of DNA or RNA, or proteins — to detect disease, predict risk, or guide treatment choices. For investors, these tests matter because they can change how illnesses are diagnosed and treated, create recurring revenue through specialized tests and companion products, and face clear regulatory and reimbursement pathways that drive commercial value; think of them as reading a biological barcode to inform medical decisions.

510(k) premarket notification regulatory

"Co-Dx recently announced a 510(k) premarket notification submission to the FDA"

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.

point-of-care medical

"The Company conceived of the Co-Dx PCR point-of-care platform"

"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.

data interoperability technical

"how data interoperability is shaping product development"

Data interoperability is the ability of different computer systems, software and devices to share, read and use the same information without extra work or errors. For investors, it matters because interoperable data reduces costs, speeds up product development and regulatory submissions, and lowers the risk of mistakes—much like having a universal plug that lets any charger power any device rather than needing adapters for each one.

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

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Company Chief Commercialization Officer represented Co-Dx in an event featuring other industry stakeholders held on August 13 in Salt Lake City, UT

SALT LAKE CITY, Aug. 18, 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 Company Chief Commercialization Officer Seth Egan recently participated in the Salt Lake Business Journal's 2026 Medical Devices and Innovation Roundtable event, held on Thursday, August 13 and moderated by the intellectual property law firm Maschoff Brennen in Salt Lake City, Utah.

The 90-minute event included discussion of topics such as the significance of recent innovations and challenges surrounding the medical device industry in Utah, the current and future impact of artificial intelligence on the industry, how data interoperability is shaping product development and forecasts for adoption, and what factors are currently shaping companies' strategies in bringing technologies from concept to commercialization.

Co-Dx recently announced a 510(k) premarket notification submission to the FDA for the Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro^® instrument. The Company conceived of the Co-Dx PCR point-of-care platform* during the height of the pandemic. Following several years of investment, development and optimization and subject to FDA clearance, the Company is undertaking commercial-readiness activities for a potential U.S. launch of the platform while also pursuing other regulatory authorizations internationally and working to expand access to PCR diagnostics on a global scale.

*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 safe harbor provisions 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 510(k) notification, the timing and outcome of FDA review, the potential clearance, regulatory authorization and commercialization of the Co-Dx PCR Flu A/B & RSV test, the Co-Dx PCR Pro® instrument and the broader Co-Dx PCR platform, and the Company's ability to commercialize the platform in decentralized point-of-care settings. Such statements are subject to a number of risks and uncertainties, including, without limitation: risks that the FDA may decline to accept the submission, request additional information, testing or modifications, delay its review, or determine not to grant clearance; risks that any clearance may be subject to limitations, conditions or labeling that restrict the contemplated use of the test or platform; risks relating to the accuracy, reliability, reproducibility and performance of the test and platform; risks associated with manufacturing scale-up, supply chains, quality systems and reliance on third parties; risks related to the performance, reliability, and market acceptance of the Co-Dx PCR platform and other Co-Dx technology; risks related to competition, technological change, and intellectual property protection; risks associated with obtaining, maintaining and complying with regulatory authorizations in jurisdictions outside the United States; 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 was Co-Diagnostics (NASDAQ: CODX) involvement in the 2026 Medical Devices and Innovation Roundtable?

Co-Diagnostics participated through its Chief Commercialization Officer, Seth Egan, at the Salt Lake Business Journal’s 2026 Medical Devices and Innovation Roundtable on August 13. According to Co-Diagnostics, the 90-minute event in Salt Lake City gathered industry stakeholders to discuss innovation, AI, data interoperability, and commercialization strategies.

What topics did Co-Diagnostics (CODX) help address at the Salt Lake City medical devices roundtable?

The roundtable covered recent medical device innovations, Utah-specific industry challenges, and AI’s current and future impact. According to Co-Diagnostics, panelists also discussed how data interoperability influences product development and adoption forecasts, and what factors are shaping strategies to move technologies from concept to commercialization.

What 510(k) submission did Co-Diagnostics (CODX) announce for its Co-Dx PCR Flu A/B & RSV test?

Co-Diagnostics announced a 510(k) premarket notification submission to the FDA for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test, run on the Co-Dx PCR Pro instrument. According to Co-Diagnostics, this submission is a regulatory step and the test remains subject to FDA review.

Has the Co-Dx PCR platform from Co-Diagnostics (CODX) been cleared by the FDA?

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

What commercialization plans does Co-Diagnostics (CODX) have for its Co-Dx PCR platform in the U.S.?

Co-Diagnostics is undertaking commercial-readiness activities for a potential U.S. launch of the Co-Dx PCR platform, subject to FDA clearance. According to Co-Diagnostics, the company is also pursuing additional regulatory authorizations internationally and aims to expand access to PCR diagnostics globally.

When did Co-Diagnostics (CODX) conceive its Co-Dx PCR point-of-care platform and why is that relevant?

Co-Diagnostics conceived the Co-Dx PCR point-of-care platform during the height of the pandemic. According to Co-Diagnostics, the platform has undergone several years of investment, development, and optimization, positioning it for potential commercialization once required regulatory clearances are obtained.