Co-Diagnostics Highlights PCR Platform Capabilities for Potential Plague Detection

Co-Diagnostics (Nasdaq: CODX) highlighted its PCR platform’s potential application to plague diagnostics if a public health need arises.

Rhea-AI Summary

Co-Diagnostics (Nasdaq: CODX) highlighted its PCR platform’s potential application to plague diagnostics if a public health need arises. No plague-specific test development has begun, and the company is not announcing a new development program.

The company believes its sputum sample-preparation experience from tuberculosis testing could support a response. Instruments and tuberculosis test kits have been deployed to select laboratories in India, where joint venture CoSara’s clinical studies are underway. A separate collaboration with ReadyGo is evaluating sample preparation for Ebola detection; feasibility work remains at an early stage. The Co-Dx PCR platform has not been cleared or authorized by the FDA and is not yet available for sale.

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Key Terms

pneumonic plague, pcr, oligonucleotide synthesis

3 terms

pneumonic plague medical

"Pneumonic plague, the most severe form of infection with the bacterium"

A severe form of plague caused by the bacterium Yersinia pestis when it infects the lungs, producing pneumonia that can be spread directly from person to person through infectious respiratory droplets. It differs from bubonic plague (which primarily affects lymph nodes) and septicemic plague (bloodstream infection); pneumonic plague progresses rapidly, can cause respiratory failure, and requires prompt medical diagnosis and antibiotic treatment to prevent transmission and death.

pcr technical

"sputum samples for bacterial PCR testing"

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.

oligonucleotide synthesis technical

"oligonucleotide synthesis capabilities through CoSara in India"

A laboratory process that chemically builds short strands of nucleic acids (DNA or RNA) by adding one nucleotide at a time in a controlled sequence. Most commercial oligonucleotide synthesis uses solid‑phase, stepwise chemistry (commonly the phosphoramidite method) where each added base is temporarily protected, coupled, and deprotected, then the finished short strand is cleaved from the solid support and purified; the method also allows introduction of chemical modifications at specific positions. Practical limits include a typical reliable length of a few dozen bases, increasing error rates for longer chains, and differences in scale and purity between small‑scale research manufacture and large‑scale therapeutic production.

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Existing Sputum Sample-Preparation Technology Provides Potential Foundation for Plague Diagnostics

Draws on Rapid-Response Experience with COVID-19, Mpox and Ebola Supported by Expanded Manufacturing Infrastructure

SALT LAKE CITY, Oct. 15, 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 highlighted capabilities of its Co-Dx PCR Pro®* point-of-care platform that could be applied to plague diagnostics, should a public health need arise. The Company is monitoring developments following the October 2 death of a laboratory worker at a plague research institute in Irkutsk, Russia.

The worker died after being hospitalized with severe pneumonia, prompting reports of a possible pneumonic plague infection. In an October 10 update, the World Health Organization (WHO) reported that Russian authorities had not identified plague or other high-threat pathogens and found no evidence of ongoing transmission. Though the cause of death remains undetermined. Pneumonic plague, the most severe form of infection with the bacterium Yersinia pestis and the only form capable of person-to-person transmission, can progress rapidly, making early identification critical.

"Emerging infectious disease threats are a constant reminder of why we built Co-Diagnostics and why we've continued to invest in the capabilities needed to respond quickly when new challenges arise," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "Our response to COVID-19 demonstrated our ability to rapidly develop and commercialize molecular diagnostics, and we've built on that foundation through our work with mpox, Ebola and other infectious diseases. Today, our integrated platform combines our patented Co-Primers® technology, sample-preparation capabilities and in-house oligonucleotide manufacturing in the United States and India, giving us greater control over the development and production of new tests."

"Sputum is a key specimen type for pneumonic plague, and our point-of-care tuberculosis program has given us experience preparing sputum samples for bacterial PCR testing. We designed the Co-Dx PCR platform to bring molecular testing closer to patients, particularly in settings where access to centralized laboratories may be limited. While we have not initiated development of a plague-specific assay, we believe our technology and experience provide a foundation to respond should the need arise."

To support its point-of-care tuberculosis program, Co-Dx has developed a proprietary, single-button instrument that prepares sputum samples for its Co-Dx PCR MTB test, addressing a longstanding challenge in decentralized bacterial PCR testing. PCR Pro instruments, MTB test kits and sample-preparation instruments have been deployed to select laboratories in India, where clinical studies by CoSara Diagnostics Pvt. Ltd. ("CoSara"), the Company's joint venture, are underway. This work could provide a foundation for evaluating sputum-based detection of other bacterial pathogens.

In September 2026, Co-Dx announced a collaboration with ReadyGo Diagnostics Ltd. ("ReadyGo") to evaluate the integration of ReadyGo's GoCollect® sample-preparation technology with the Co-Dx PCR platform for decentralized Ebola detection. The collaboration builds on a July 2026 proof-of-concept study involving an extraction-free Co-Primers® Ebola assay using diluted plasma, the first plasma-based assay designed for the PCR Pro. Feasibility evaluation of the GoCollect technology remains at an early stage.

Co-Dx has continued to invest in its assay development and manufacturing infrastructure, including in-house production of its patented Co-Primers® technology in Salt Lake City, Utah, and oligonucleotide synthesis capabilities through CoSara in India. These resources support the Company's ongoing efforts to develop and manufacture molecular diagnostic solutions for emerging infectious disease threats.

Co-Diagnostics has not initiated design or development work on a plague-specific diagnostic test and is not announcing a new development program at this time. The Company will continue to monitor developments closely and believes its existing technology and experience position it to respond promptly should circumstances warrant.

*The Co-Dx PCR platform (including PCR Home®, PCR Pro®, mobile app, and 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 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 to identify genetic markers for applications beyond 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. These statements include, but are not limited to, statements regarding the potential suitability of the Co-Dx PCR Pro platform for point-of-care plague detection; the Company's ability to develop, validate and obtain regulatory authorization for a plague test, should it elect to do so; the ability of the Company's sputum sample-preparation technology to support specimen types and pathogens beyond tuberculosis; the anticipated results of the Company's evaluation of ReadyGo's GoCollect technology, including whether plasma can be established as a compatible sample type for the Co-Dx PCR platform; and the Company's ability to respond to emerging infectious disease threats.

Such statements are subject to risks and uncertainties, including risks that the public health situation described in this press release may not result in demand for plague diagnostics; risks that a plague test may not be technically feasible on the Co-Dx PCR platform, including risks related to assay development, sample-processing compatibility, analytical and clinical validation, and access to the specimens and biosafety facilities required for development; risks that sample-preparation methods developed for tuberculosis may not perform as anticipated with other pathogens or specimen types; risks related to regulatory review; risks that the Company's prior performance in responding to COVID-19, mpox, Ebola or other infectious disease threats may not be indicative of future results; availability of development resources; public health priorities; and other risks described in the Company's filings with the Securities and Exchange Commission. There can be no assurance that any plague diagnostic test will be developed, validated, authorized or commercialized, or that evaluation of the ReadyGo technology will establish plasma sample compatibility with the Co-Dx PCR platform.

Actual results may differ materially from those expressed or implied in these statements. Readers are cautioned not to place undue reliance on forward-looking statements. The Company undertakes no obligation to update these statements except as required by law.

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SOURCE Co-Diagnostics