Co-Diagnostics, Inc. Completes Updated Clade Ib Analysis of 2-Gene Mpox RUO Test

Rhea-AI Summary

Co-Diagnostics, Inc. (CODX) has completed an updated in silico analysis of its Co-Dx™ Logix Smart® Mpox (2-Gene) RUO test. The analysis shows that the test should maintain full reactivity against mpox strains circulating over the past year, including the more transmissible and severe clade Ib. This comes as the Africa CDC declared mpox a Public Health Emergency of Continental Security on August 13, 2024, followed by the WHO declaring it a public health emergency of international concern. As of August 27, 2024, Africa reported over 22,800 mpox cases and 622 deaths. The Company's 2-gene mpox test was previously shown to perform better at detecting mpox from saliva samples compared to other assays in a study published in December 2023.

Positive

• The Co-Dx™ Logix Smart® Mpox (2-Gene) RUO test is expected to retain full reactivity against current mpox strains, including the more severe clade Ib
• A study published in December 2023 showed that the Co-Dx test performed better at detecting mpox from saliva samples compared to other assays
• The company has received requests from distributors and customers in several countries for test kits for performance validation purposes

Negative

• None.

Insights

Medical Research Analyst

Co-Diagnostics' updated analysis of their Mpox RUO test is a proactive step in addressing the evolving Mpox outbreak. The in silico analysis suggests the test's continued effectiveness against new strains, including the more transmissible and severe clade Ib. This is important given the recent Public Health Emergency declarations by Africa CDC and WHO.

The test's apparent superiority in detecting Mpox from saliva samples, as published in a peer-reviewed journal, is a significant advantage. However, it's important to note that these are still Research Use Only (RUO) tests, not yet approved for diagnostic procedures. The company's preparedness for potential demand is commendable, but regulatory hurdles remain before widespread clinical use.

Market Research Analyst

Co-Diagnostics' proactive approach to the Mpox outbreak positions them well in the rapidly evolving infectious disease diagnostics market. The company's ability to quickly adapt their test to new strains demonstrates technological agility, a valuable trait in this sector. However, the RUO status of their tests limits immediate commercial potential.

The mention of distributor and customer requests indicates potential market demand, particularly in Africa where cases are surging. The company's vision of improving global accessibility to diagnostics aligns with current public health needs. Yet, investors should note that the path to commercialization, including regulatory approvals, can be lengthy and uncertain. The company's future success may hinge on their ability to transition from RUO to approved diagnostic tools efficiently.

SALT LAKE CITY, Sept. 5, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that the Company has performed an in silico analysis of the Co-Dx™ Logix Smart® Mpox (2-Gene) RUO test to evaluate the possible impact of clade Ib mpox on the test. The results of the analysis show that the test should retain full reactivity against mpox strains circulating over the last year, including clade 1b.

On August 13, 2024, the Africa Centres for Disease Control and Prevention (Africa CDC) declared mpox (formerly monkeypox) a Public Health Emergency of Continental Security (PHECS), which was followed the next day by the World Health Organization Director-General declaring the illness a public health emergency of international concern (PHEIC). On August 27, 2024, the Africa CDC reported that mpox infections in Africa had reached more than 22,800 cases, resulting in 622 deaths. Clade Ib mpox appears to be more transmissible between humans and more severe than clade Ia or clade II, the version responsible for the 2022 mpox outbreak.

In response to the outbreak in 2022, Co-Dx designed and verified two Research Use Only (RUO) tests for mpox* virus on the Company's patented Co-Primers® platform. The version of the test evaluated in the recent in silico analysis (a type of experiment performed by computer to compare the test's primer sequences against known strains of mpox) was the 2-gene version of the Company's mpox test. This test was also included in a study published in the Oxford Academic journal Open Forum Infectious Diseases in December, 2023, which showed that the Co-Dx test performed better at detection of mpox from saliva samples than the other assays surveyed.

"Co-Dx's mission has always been to remain on the forefront of cutting-edge PCR testing solutions, as illustrated by our efforts from the very beginning of the COVID-19 pandemic and our upcoming Co-Dx PCR at-home and point-of-care platform**, which also features technology to help track infectious disease outbreaks," remarked Dwight Egan, Company CEO.

"The Company has received requests from distributors and customers in several countries around the world for test kits to be used for performance validation purposes in their labs, and we remain committed to our vision of improving the global accessibility of high-quality infectious disease diagnostics."

*The Co-Dx Logix Smart Mpox and Co-Dx Logix Smart Mpox (2-Gene) tests are for Research Use Only. Not for use in diagnostic procedures.

**The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests and software) is subject to review by the FDA and/or other regulatory bodies and is not available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA and are not 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 and to locate 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. Forward-looking statements include statements made with respect to our Co-Dx PCR platform. 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 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 14, 2024, 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

FAQ

What did Co-Diagnostics' recent analysis of their Mpox test reveal?

Co-Diagnostics' in silico analysis of the Co-Dx™ Logix Smart® Mpox (2-Gene) RUO test showed that it should retain full reactivity against mpox strains circulating over the last year, including the more transmissible and severe clade Ib.

How many mpox cases were reported in Africa as of August 27, 2024?

According to the Africa CDC, as of August 27, 2024, there were more than 22,800 mpox cases reported in Africa, resulting in 622 deaths.

When did the WHO declare mpox a public health emergency of international concern?

The World Health Organization Director-General declared mpox a public health emergency of international concern (PHEIC) on August 14, 2024.

How did Co-Diagnostics' Mpox test perform in a recent study?

A study published in the Oxford Academic journal Open Forum Infectious Diseases in December 2023 showed that Co-Diagnostics' mpox test performed better at detecting mpox from saliva samples compared to other assays surveyed.