Co-Diagnostics Develops Ebola Assay Strategy Following Recent Global Outbreak Alert

Co-Diagnostics (Nasdaq: CODX) announced completion of its assay development strategy for Bundibugyo virus (BDBV), linked to the current Ebola outbreak in the Democratic Republic of the Congo and Uganda.

Rhea-AI Summary

Co-Diagnostics (Nasdaq: CODX) announced completion of its assay development strategy for Bundibugyo virus (BDBV), linked to the current Ebola outbreak in the Democratic Republic of the Congo and Uganda.

The company plans to use its Co-Dx PCR point-of-care platform, which remains under regulatory review and not yet for sale.

Argus May 19 session

+43.80% close to close 151.4x rel. volume Open Argus

Details

News Market Reaction – CODX

On May 19, the day this news came out, CODX closed 43.80% above the previous close. That session’s volume was 151.4x the stock’s average daily volume.

Data tracked by StockTitan Argus for the May 19 session.

Key Figures

Q1 2026 revenue: $145,954 Q1 2026 net loss: $9.14 million Q1 operating expenses: $9.16 million +5 more

Q1 2026 revenue

$145,954

Total revenue reported in 2026-05-14 10-Q

Q1 2026 net loss

$9.14 million

Net loss in 2026-05-14 10-Q

Q1 operating expenses

$9.16 million

Operating expenses in 2026-05-14 10-Q

Cash and equivalents

$8.23 million

Balance at March 31, 2026 per 10-Q

Operating cash used

$7.85 million

Cash used in operations in Q1 2026

ATM proceeds

$4.33 million

Raised via at-the-market stock program in Q1 2026

Shelf capacity

$150,000,000

Maximum aggregate offering under S-3 shelf filed 2026-05-12

Ebola outbreak cases

8 lab-confirmed, 246 suspected, 80 suspected deaths (DRC); 2 lab-confirmed, 1 death (Uganda)

WHO data as of May 17 in article

Historical Context

5 past events · Latest: May 14

5 events

1. May 14

   Q1 2026 earnings

   24h Move

   -21.2%

   Weak revenue and sizable net loss with ongoing cash concerns.

2. May 08

   JV facility lease

   24h Move

   +31.1%

   Saudi CoMira manufacturing lease advancing regional PCR production.

3. Apr 30

   Earnings date set

   24h Move

   +1.3%

   Announcement of Q1 2026 release date and investor webcast details.

4. Apr 16

   TB summit presentation

   24h Move

   +2.8%

   Invitation to present Co-Dx MTB test at Stop TB Partnership Summit.

5. Apr 14

   Conference showcase

   24h Move

   -4.8%

   Showcasing Co-Dx PCR platform and CE-IVD tests at ESCMID 2026.

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

Key Terms

pcr, point-of-care, decentralized diagnostics, public health emergency of international concern, +3 more

7 terms

pcr medical

"such as those provided by the Co-Dx PCR point-of-care platform"

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.

point-of-care medical

"such as those provided by 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.

decentralized diagnostics medical

"underscore the growing importance of decentralized diagnostics and real-time situational awareness"

Decentralized diagnostics are medical tests and tools designed to be performed outside traditional hospital or central lab settings—at a clinic, pharmacy, workplace, or at home—using portable devices, rapid assays, or remote monitoring. For investors this matters because shifting testing closer to the patient can lower costs, speed results, expand the customer base, create recurring sales and data revenue streams, and change regulatory and reimbursement dynamics much like how mobile banking reshaped finance.

public health emergency of international concern regulatory

"WHO declared an outbreak of Ebola disease caused by BDBV as a public health emergency of international concern"

A public health emergency of international concern is an official alarm declared by the World Health Organization when a disease outbreak poses a serious risk across countries and needs coordinated global action. Think of it like a neighborhood-wide fire alarm that prompts governments to share information, recommend travel or trade measures, and mobilize medical resources—actions that can quickly affect supply chains, consumer demand, regulation and market volatility, so investors watch these declarations closely.

contact tracing medical

"These measures include increased traveler monitoring, contact tracing coordination, and enhanced hospital preparedness"

Contact tracing is the process public health authorities use to identify people who have been near someone with an infectious disease, notify them, and recommend testing, isolation, or treatment. Investors care because effective tracing can limit outbreaks, reduce business disruptions, avoid regulatory closures, and speed economic recovery—think of it as quickly finding and removing sparks so a small fire doesn’t spread through a building.

cloud-connected architecture technical

"including the ability to support decentralized testing and cloud-connected architecture"

A cloud-connected architecture is a design where devices, applications, or systems rely on remote servers and internet services to store data, run software, or coordinate tasks instead of doing everything locally. For investors, it matters because this setup can lower upfront costs, enable faster updates and scaling, create ongoing service revenue, but also introduces dependencies on network reliability, data security, and third-party providers—similar to a house that trades its own generator for a central utility.

fda regulatory

"subject to review by the FDA and/or other regulatory bodies and is not yet available for sale"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

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

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Recent pathogens illustrate need for improved situational awareness capabilities, such as those provided by the Co-Dx PCR point-of-care platform

Follows outbreak of Ebola and WHO emergency declaration, and enhanced CDC traveler screening measures

SALT LAKE CITY, May 19, 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 completed the assay development strategy for the Bundibugyo virus ("BDBV") currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo and Uganda.

"We are pleased to report that we have completed the assay development strategy for BDBV, and should a situation arise requiring the assay, we expect we would be well positioned to execute the strategy and rapidly make the test available," said Dwight Egan, Co-Diagnostics Chief Executive Officer. "In addition to the role that rapid, gold-standard PCR diagnostics can play in identifying infected patients and helping limit the spread of deadly diseases like Ebola, we believe recent events also underscore the growing importance of decentralized diagnostics and real-time situational awareness in helping public health authorities track and contain outbreaks."

On May 17, WHO declared an outbreak of Ebola disease caused by BDBV as a public health emergency of international concern ("PHEIC"). As of May 17, eight laboratory-confirmed cases, 246 suspected cases, and 80 suspected deaths have been reported in the Democratic Republic of the Congo, along with two laboratory-confirmed cases and one reported death in Uganda.

The announcement also follows recent guidance from the U.S. Centers for Disease Control and Prevention ("CDC") regarding enhanced screening and monitoring measures for travelers arriving from regions impacted by Ebola outbreaks. According to the CDC, these measures include increased traveler monitoring, contact tracing coordination, and enhanced hospital preparedness efforts, underscoring the importance of rapid testing and real-time outbreak visibility in responding to emerging infectious disease threats.

Mr. Egan added, "The COVID-19 pandemic reinforced the importance of preparedness and rapid response capabilities for emerging infectious disease threats, and we believe it is important to be positioned to respond quickly as we have in the past when situations like these have emerged. We designed the Co-Dx PCR platform* with these types of needs in mind, including the ability to support decentralized testing and cloud-connected architecture. Real-time visibility into outbreak activity can play an important role in helping public health authorities identify, monitor, and respond to emerging infectious disease threats. We look forward to collaboration with governmental and non-governmental agencies and organizations on the future development of this test, as needed."

*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: (i) the Company's ability to execute its assay development strategy for Bundibugyo virus ("BDBV"); (ii) the potential future development, validation, regulatory review, commercialization, manufacture, and distribution of a BDBV test; (iii) the Company's ability to rapidly respond to emerging infectious disease threats; (iv) the potential utility, effectiveness, and adoption of the Co-Dx PCR platform for decentralized diagnostics and outbreak monitoring; (v) the potential role of real-time situational awareness and cloud-connected diagnostic systems in public health response efforts; and (vi) potential collaborations with governmental and non-governmental organizations relating to infectious disease preparedness and response. 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 ability to successfully develop, validate, obtain regulatory authorization or approval for, manufacture, and commercialize any BDBV assay or related products; risks related to regulatory review by the FDA or other regulatory authorities; risks related to the performance, reliability, and market acceptance of the Co-Dx PCR platform; 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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-develops-ebola-assay-strategy-following-recent-global-outbreak-alert-302775926.html

SOURCE Co-Diagnostics

FAQ

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

What did Co-Diagnostics (NASDAQ: CODX) announce on May 19, 2026 about its Ebola assay strategy?

Co-Diagnostics announced it completed an assay development strategy for Bundibugyo virus (BDBV) amid the current Ebola outbreak. According to Co-Diagnostics, this positions the company to rapidly make a test available if needed, using its Co-Dx PCR point-of-care platform.

How is the Co-Dx PCR platform intended to support Ebola (BDBV) outbreak response for CODX?

The Co-Dx PCR platform is intended to provide rapid, gold-standard PCR testing at the point of care. According to Co-Diagnostics, it is designed for decentralized testing, cloud-connected architecture, and real-time situational awareness to help public health authorities track and contain infectious disease outbreaks.

Is Co-Diagnostics' Co-Dx PCR platform for Ebola testing currently available for sale?

The Co-Dx PCR platform, including Ebola-related tests, is not yet available for sale. According to Co-Diagnostics, the platform and associated tests remain subject to review by the FDA and other regulators before any potential commercialization can occur.

How does the WHO Ebola outbreak declaration relate to Co-Diagnostics (CODX) assay plans?

The WHO declared an Ebola outbreak caused by Bundibugyo virus a public health emergency of international concern. According to Co-Diagnostics, this declaration underscores the need for rapid PCR testing and informed its completion of an assay development strategy for potential BDBV testing.

What CDC traveler screening measures are tied to Co-Diagnostics' Ebola assay strategy?

The CDC issued guidance for enhanced screening and monitoring of travelers from Ebola-affected regions. According to Co-Diagnostics, these measures, which include increased monitoring and hospital preparedness, highlight the importance of rapid PCR testing and real-time outbreak visibility that its Co-Dx PCR platform aims to support.

Why does Co-Diagnostics link COVID-19 lessons to its Ebola (BDBV) assay development?

Co-Diagnostics says COVID-19 highlighted the importance of preparedness and rapid response for emerging infectious diseases. According to the company, this experience influenced designing the Co-Dx PCR platform to enable decentralized testing, cloud connectivity, and quick response when new outbreaks like Ebola emerge.