Co-Diagnostics, Inc. Performs Analysis of Chikungunya Co-Primers® to Confirm Reactivity Against Known Virus Strains

SALT LAKE CITY, Sept. 11, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (NASDAQ:CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that it has performed an in silico analysis of the primers sets used in its Co-Primers®-based PCR tests for the detection of chikungunya virus (or "CHIKV"), showing a high homology against over 1,200 CHIKV sequences and confirming reactivity of the CHIKV primers against known recent strains of the virus.

As of July, there have been nearly 250,000 cases and 90 deaths from CHIKV worldwide, primarily concentrated in South America, but also found in countries across Africa, Asia and Europe. An estimated 5.6 billion people currently live in at-risk areas across 119 countries as warming trends contribute to expanded regions for the mosquitoes that can carry CHIKV.

Chikungunya imposes a significant economic burden, especially in low- and middle-income countries. Long-term consequences for the patient are also common, particularly joint pain that can be debilitating, with 40% of people contracting chronic chikungunya arthritis, leading to the pain lasting months or even years according to the Mayo Clinic. Less common complications include auto-immune disorders and chronic fatigue.

The Co-Diagnostics Logix Smart® ZDC Test* received CE-marking regulatory clearance in 2019 to be sold as an in vitro diagnostic ("IVD") for the viruses that cause Zika, dengue and chikungunya. The test functions via the Company's patented Co-Primers technology and a single-step reverse transcriptase real-time PCR process to detect and differentiate between the viral RNA of Zika, dengue (all 4 serotypes), and chikungunya in blood drawn from patients. It is available for markets that accept CE-marking as valid regulatory clearance, pending local product registration requirements.

Differentiating CHIKV cases from other infections with similar symptoms, such as dengue, helps physicians avoid administering certain pain and fever medications that can increase risk of bleeding and be life-threatening in patients with severe dengue infections. As an arbovirus spread by mosquitoes, accurate diagnosis is also vital to indicate to an infected patient that they should take additional precautions to limit contact with mosquitoes, to prevent further spread of the virus.

Co-Dx also offers its Co-Primers-based environmental use only Vector Smart® VZDC Test to mosquito abatement districts ("MADs"), as part of its suite of vector control tests used by around 30 MADs across approximately 20 U.S. states to identify pathogens such as Zika, dengue, chikungunya, West Nile virus, St. Louis encephalitis, and Eastern and Western equine encephalitis in mosquito pools. The Vector Smart VZDC Test CHIKV primer sets are the same as those used in the Logix Smart ZDC test.

Co-Diagnostics Indian joint venture CoSara Diagnostics Pvt Ltd received clearance in October 2021 by Indian authorities to manufacture and sell its SaraGene™ Dengue and Chikungunya Multiplex RT-PCR test as an IVD, which is also built on the Company's Co-Primers platform technology.

*This product is for export only and is not for sale in the United States.

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 to detect and/or analyze 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 and to identify genetic markers for use in applications other than infectious disease.

Forward-Looking Statements:

This press release contains forward-looking statements. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release include statements regarding our belief that Co-Primers tests for chikungunya can detect known recent strains of the virus as cases spike. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 27, 2025, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.

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SOURCE Co-Diagnostics