Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test

Rhea-AI Summary

Co-Diagnostics (Nasdaq: CODX) announced submission of a Dual FDA 510(k) premarket notification, together with a concurrent CLIA Waiver by Application, for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test to be used on the Co-Dx PCR Pro instrument in decentralized point-of-care settings.

According to Co-Diagnostics, the filing is supported by completed clinical and analytical performance studies, including a clinical trial of more than 1,400 symptomatic patients across nine U.S. sites and an analytical program of 27 studies with over 10,000 PCR test runs, including a multicenter reproducibility study. The company states that, if the CLIA waiver is granted, the test could be used in waived point-of-care environments, supporting expanded access to PCR testing. Co-Diagnostics highlights that its Co-Dx PCR platform is designed to pair lower-cost instrumentation and consumables with cloud-based data aggregation to help track localized outbreaks, but notes the platform remains under FDA and other regulatory review and is not yet available for sale.

Positive

• Dual 510(k) and CLIA Waiver submitted to FDA for Flu A/B & RSV test
• >1,400 symptomatic patients enrolled across nine U.S. clinical sites
• 27 analytical studies and over 10,000 PCR test runs completed
• Platform integrates lower-cost PCR hardware with cloud-based data aggregation for outbreaks

Negative

• Co-Dx PCR platform remains subject to FDA and other regulatory review
• Platform and associated tests are not yet available for sale

Market Context

A prior tuberculosis partnership announcement was followed by -3.39%, placing this submission within...

Analysis

A prior tuberculosis partnership announcement was followed by -3.39%, placing this submission within a record of weak post-news reactions. The active S-3 resale registration and low short positioning provide additional context to monitor.

Key Figures

Premarket notification: 510(k) Clinical enrollment: more than 1,400 patients Clinical sites: 9 U.S. clinical sites +2 more

5 metrics

Premarket notification 510(k) FDA submission for the upper respiratory multiplex test

Clinical enrollment more than 1,400 patients Symptomatic patients in the clinical study

Clinical sites 9 U.S. clinical sites Geographically distinct sites supporting the submission

Analytical studies 27 studies Analytical program supporting the test

PCR test runs over 10,000 upper respiratory PCR test runs Analytical program

Historical Context

5 past events · Latest: Jul 28 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jul 28	Partnership development	Positive	-30.9%	CoSara supplied Ebola test kits and completed an Ebola assay proof-of-concept study.
Jul 22	Clinical study initiation	Positive	-3.4%	CoSara initiated Indian clinical studies for a tuberculosis test on its PCR platform.
Jul 16	Leadership appointment	Positive	-0.2%	Wes Lindsey joined as chief scientific officer with FDA submission experience.
Jul 08	Workshop participation	Positive	-2.6%	Co-Diagnostics participated in a global near-point-of-care TB diagnostics workshop.
Jul 01	Study completion	Positive	-0.7%	Clinical and analytical studies were completed ahead of the planned FDA submission.

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

Pattern Detected

CODX's five recent news events were followed by negative 24-hour price reactions, including announcements describing partnerships, studies, and regulatory preparation.

Key Terms

510(k) premarket notification, clia waiver by application, multiplex test, real-time pcr

4 terms

510(k) premarket notification regulatory

"submitted a Dual 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

"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.

multiplex test medical

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

A multiplex test is a laboratory diagnostic that checks one patient sample for several different targets at the same time — for example multiple viruses, bacteria, or biological markers — like a Swiss Army knife that does several jobs at once. For investors, multiplex tests matter because they can lower costs, speed up diagnosis, increase lab throughput, and open larger sales or reimbursement opportunities, while also bringing regulatory and manufacturing complexity that can affect commercial success.

real-time pcr technical

"The Co-Dx PCR platform combines real-time PCR quality"

Real-time PCR is a laboratory method that copies and measures specific genetic material (DNA or RNA) as the reaction happens, giving immediate numerical results rather than only an end-point yes/no. For investors, it matters because it underpins fast, sensitive medical tests and research tools; performance, regulatory acceptance, and manufacturing capacity for real-time PCR systems can directly affect demand, revenue potential, and competitive position in the diagnostics and biotech markets.

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

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Submission includes a concurrent CLIA Waiver by Application for use of the test on the Co-Dx PCR Pro^® instrument in decentralized point-of-care settings

SALT LAKE CITY, Aug. 6, 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 submitted a Dual 510(k) premarket notification, with a concurrent CLIA Waiver by Application, to the U.S. Food and Drug Administration ("FDA") for the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro^® instrument*. The submission follows the Company's previously announced completion of the clinical and analytical performance studies supporting the test.

"The submission of this 510(k) premarket notification and CLIA Waiver by Application represents one of the most significant milestones in Co-Diagnostics' history and reflects years of investment in developing the Co-Dx PCR platform," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "With this submission, we are entering the next phase of our regulatory pathway as we move towards our goal of bringing decentralized PCR diagnostics closer to the patient through a platform designed to improve accessibility, affordability and ease of use, with a cloud-based infrastructure built to power situational awareness as infections spread through communities."

The submission is supported by the clinical and analytical performance studies previously reported by the Company, including a clinical study enrolling more than 1,400 symptomatic patients across nine geographically distinct U.S. clinical sites, and an analytical program spanning 27 studies and over 10,000 upper respiratory PCR test runs. The analytical work included a multicenter reproducibility study, which evaluated performance across multiple operators, sites and instruments. Together, these studies support the Company's concurrent CLIA Waiver by Application, which, if granted, would enable use of the test in decentralized waived point-of-care settings and contribute to expanded access to molecular PCR testing outside traditional laboratory environments.

The Co-Dx PCR platform combines real-time PCR quality with a lower-cost instrument and consumable model, and integrates an innovative cloud-based infrastructure with data aggregation with the goal of helping to track localized outbreaks as they occur. These features differentiate the platform from existing decentralized and point-of-care molecular systems and support the Company's expansion into near-patient and decentralized testing environments.

*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 the Company's 510(k) notification and concurrent CLIA Waiver by Application, the timing and outcome of FDA review, the Company's ability to obtain regulatory clearance or a CLIA waiver for the Co-Dx™ PCR Flu A/B & RSV test, the expected performance and commercialization of the test and the Co-Dx PCR Pro^® instrument, the Company's plans to expand the Co-Dx PCR platform with additional assays and applications, 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: including 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 or a CLIA waiver; risks that any clearance or waiver 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; 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 on August 6, 2026 about its Flu A/B & RSV test?

Co-Diagnostics announced submission of a Dual 510(k) premarket notification and concurrent CLIA Waiver by Application to the FDA for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test, intended for use on the Co-Dx PCR Pro instrument in decentralized point-of-care settings.

What is a Dual 510(k) and CLIA waiver submission for Co-Diagnostics (CODX)?

A Dual 510(k) and CLIA waiver submission seeks FDA clearance for the test and simultaneous CLIA waiver status. According to Co-Diagnostics, this combined filing could, if granted, allow the Flu A/B & RSV test to be used in decentralized, waived point-of-care environments outside traditional laboratories.

What clinical data supports Co-Diagnostics’ Co-Dx PCR Flu A/B & RSV test submission?

According to Co-Diagnostics, the submission is supported by a clinical study enrolling more than 1,400 symptomatic patients at nine geographically distinct U.S. clinical sites, plus 27 analytical studies and over 10,000 upper respiratory PCR test runs, including a multicenter reproducibility evaluation across operators, sites, and instruments.

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

No. Co-Diagnostics states that the Co-Dx PCR platform, including PCR Pro, PCR Home, mobile app and associated tests, is subject to review by the FDA and other regulators and is not yet available for sale, so investors should not assume current commercialization or revenue from this platform.

How could a CLIA waiver affect Co-Diagnostics’ Flu A/B & RSV point-of-care test?

If the CLIA Waiver by Application is granted, Co-Diagnostics explains the Flu A/B & RSV test could be used in decentralized, waived point-of-care settings, potentially expanding access to molecular PCR testing beyond traditional laboratories while leveraging the platform’s lower-cost model and cloud-based data aggregation features.

What makes Co-Diagnostics’ Co-Dx PCR platform different from other point-of-care molecular systems?

According to Co-Diagnostics, the Co-Dx PCR platform combines real-time PCR quality with a lower-cost instrument and consumable model and an innovative cloud-based infrastructure for data aggregation, aiming to help track localized outbreaks and support expansion into near-patient and decentralized testing environments.