Co-Diagnostics Stock Price, News & Analysis

Co-Diagnostics, Inc. (NASDAQ: CODX) is a Utah-based molecular diagnostics company that develops, manufactures and markets diagnostics technologies built around nucleic acid detection and analysis. According to the company’s public disclosures, its technologies are utilized in tests designed to detect and/or analyze DNA and RNA, and it has created a unique, patented platform for the development of molecular diagnostic tests.

The company’s technology foundation includes proprietary methods and intellectual property that support the design of molecular assays. Earlier descriptions note that Co-Diagnostics has acquired certain patented diagnostic testing technology, embodied in patent applications and trade secrets, aimed at making DNA testing for diseases faster, higher in performance, and more cost efficient than traditional approaches. The company has described the use of biophysical models and statistical bioinformatics to develop novel molecular technologies and has successfully developed and commercialized assays in the infectious disease area to demonstrate its capabilities.

Core technologies and molecular diagnostics focus

Co-Diagnostics reports that its technologies are used in tests based on the detection and/or analysis of nucleic acid molecules. The company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform, which it identifies as subject to review by the U.S. Food and Drug Administration (FDA) and other regulatory bodies and not currently available for sale. In addition, the company states that it uses its technology to identify genetic markers for applications other than infectious disease.

A key element of Co-Diagnostics’ platform is its Co-Primers® chemistry, referenced in company communications describing PCR tests for infectious agents such as influenza viruses and chikungunya virus. The company has reported in silico analyses of Co-Primers-based tests, including the Logix Smart® ABC test for influenza A, influenza B and COVID-19, to evaluate homology against thousands of viral sequences and to confirm reactivity of primer sets against emerging strains. These disclosures highlight the company’s focus on molecular assay design and performance characterization.

Point-of-care Co-Dx PCR platform

Co-Diagnostics has described an upcoming Co-Dx PCR platform intended for at-home and point-of-care use, which includes the Co-Dx PCR Home™ and Co-Dx PCR Pro™ instruments, a mobile app, and associated tests and software. Public statements emphasize that this platform is designed to deliver PCR testing in decentralized settings and that it remains subject to regulatory review and is not available for sale.

The company has discussed multiple test applications under development or evaluation on the Co-Dx PCR platform, including:

• Co-Dx PCR Flu A/B, COVID-19, RSV upper respiratory multiplex test kit, designed for simultaneous detection and differentiation of influenza A, influenza B, COVID-19 and RSV on the Co-Dx PCR Pro instrument, using reverse-transcriptase PCR for decentralized upper respiratory infection testing.
• Co-Dx PCR Mycobacterium Tuberculosis (MTB) Test Kit on the Co-Dx PCR Pro instrument, for which the company has referenced preclinical and planned clinical performance testing.
• Co-Dx PCR HPV multiplex test designed to identify the presence of eight human papillomavirus genotypes, including genotypes classified as high-risk for cancer, with preclinical studies focused on validating and optimizing Co-Primers chemistry and differential detection of high-risk genotypes.

Co-Diagnostics has also announced the development of a proprietary sample preparation instrument intended to streamline and simplify workflow for point-of-care testing on the Co-Dx PCR platform, particularly for the MTB test.

Intellectual property and patents

The company’s disclosures emphasize a focus on intellectual property protection. Earlier descriptions reference three patent applications and related trade secrets underlying its diagnostic technology. More recent news reports that the Australian Patent Office granted Australian Patent No. AU2022270084A1, which the company states strengthens its intellectual property portfolio around the Co-Dx PCR platform.

According to the company, this Australian patent provides broad protection in Australia for proprietary systems and methods used for nucleic acid detection and analysis, including claims covering the design and operation of the Co-Dx PCR Pro instrument and test cups. The company characterizes this patent as the first granted for its new point-of-care testing platform and as an important component of its efforts to secure global protection for its technology.

Joint ventures and international collaborations

Co-Diagnostics has disclosed several international collaborations and joint ventures that extend the reach of its molecular diagnostics technology:

• CoSara Diagnostics Pvt. Ltd. (CoSara): An Indian joint venture between Co-Diagnostics and Ambalal Sarabhai Enterprises Limited (ASE Group). Company news describes CoSara’s participation in regional conferences in India to introduce SARAGENE® diagnostic products and the upcoming Co-Dx PCR platform, as well as its role in supporting clinical performance studies for the Co-Dx PCR MTB test and in manufacturing the PCR Pro instrument and MTB test cups.
• CoMira Diagnostics: A joint venture with Arabian Eagle Manufacturing in the Kingdom of Saudi Arabia (KSA) and 18 MENA nations, described in company communications as focused on researching, developing, manufacturing, assembling, distributing and commercializing Co-Dx technologies and intellectual property in those markets.

Co-Diagnostics has also reported that it is exploring the possibility of a strategic transaction, which may include a merger with a special purpose acquisition company (SPAC), for CoSara Diagnostics, and has engaged a financial advisor to pursue such a transaction. The company has stated that it views this as a potential path to help CoSara advance its mission of increasing the availability of molecular diagnostic products at accessible prices.

AI initiatives and digital integration

In its public updates, Co-Diagnostics has announced the formation of an artificial intelligence (AI) business unit to integrate existing and planned AI applications into a platform referred to as Co-Dx Primer Ai™. The company has also described plans to present on the Co-Dx PCR platform and AI integration at industry conferences, including a presentation titled “Exploring the Promise of Portable, Cloud-Connected PCR Diagnostics.”

According to these disclosures, the company’s work in this area includes an intuitive smartphone interface for its Co-Dx PCR platform and the use of AI to minimize user error and improve outcomes in real-time point-of-care testing. These statements indicate that digital connectivity and AI-enabled support tools are intended to be part of the broader platform design, subject to regulatory review.

Regulatory status and product availability

Across multiple press releases, Co-Diagnostics consistently notes that the Co-Dx PCR platform (including the Co-Dx PCR Home, Co-Dx PCR Pro, mobile app, and associated tests and software) is subject to review by the FDA and/or other regulatory bodies and is not available for sale. Certain tests, such as the Logix Smart ABC test for influenza A, influenza B and SARS-CoV-2, are described as not approved or cleared by the FDA and intended for export only, not for sale in the United States. The company has also referenced CE-marking for the Logix Smart ABC test for simultaneous detection and differentiation of influenza A, influenza B and SARS-CoV-2.

Co-Diagnostics has reported that it has initiated clinical evaluations for its upper respiratory multiplex point-of-care test on the Co-Dx PCR platform to support a planned submission to the FDA for 510(k) clearance, and that results may also support submissions to other regulatory bodies. For tests intended for markets such as India, the company has described preclinical and planned clinical performance testing in alignment with local regulatory requirements.

Capital markets activity and listing status

Co-Diagnostics’ common stock trades on the Nasdaq Capital Market under the symbol CODX. Public filings show that the company has undertaken registered direct offerings of common stock and pre-funded warrants pursuant to an effective shelf registration statement, with proceeds intended for working capital and general corporate purposes. These offerings have involved institutional investors and a placement agent, with customary terms, participation rights and offering expenses disclosed in Form 8-K filings.

The company has also disclosed that it received a notification from the Nasdaq Stock Market granting an additional 180-day grace period, until January 5, 2026, to regain compliance with the $1.00 minimum bid price requirement. Co-Diagnostics has stated that it provided written notice of its intention to cure the deficiency, including by effecting a reverse stock split if necessary. Subsequently, the company announced that its stockholders approved, and the company implemented, a reverse stock split at a ratio of 1-for-30, with the stated objective of enabling the company to regain compliance with Nasdaq’s minimum bid price requirement. The company has reported that its common stock continues to trade on the Nasdaq Capital Market under the CODX symbol on a split-adjusted basis.

Financial reporting and SEC compliance

Co-Diagnostics files periodic and current reports with the U.S. Securities and Exchange Commission (SEC), including Forms 10-K, 10-Q and 8-K. In its quarterly financial reports and related press releases, the company provides information on revenue, operating expenses, operating loss, net loss, cash and cash equivalents, and other financial metrics, as well as non-GAAP measures such as adjusted EBITDA. The company explains that adjusted EBITDA is used by management as a supplemental tool for evaluating operating performance and for internal budgeting and planning, and that it should not be considered a substitute for GAAP results.

The company’s SEC filings also describe securities purchase agreements, placement agency agreements, and other material definitive agreements related to capital raising activities, including terms such as offering price, number of shares issued, participation rights, and use of proceeds. These disclosures provide investors with details about the company’s financing structure and capital resources.

Engagement with global health and diagnostics community

Co-Diagnostics and its joint ventures participate in scientific, clinical and industry events related to diagnostics and public health. Company announcements describe involvement in conferences and workshops focused on tuberculosis diagnostics, virology, point-of-care testing, and laboratory practice, including events organized by regional professional associations and international organizations. Through these activities, the company presents its molecular diagnostic technologies, discusses adoption and implementation considerations, and engages with stakeholders in markets such as India, the South-East Asian Region and the Middle East and North Africa.

Position within the medical diagnostics industry

Within the broader surgical and medical instrument manufacturing and diagnostics sector, Co-Diagnostics positions itself as a molecular diagnostics company centered on nucleic acid testing technologies, proprietary assay design chemistry, and a developing point-of-care PCR platform. Its disclosures emphasize intellectual property, assay development for infectious diseases, joint ventures in key international markets, and integration of AI and digital tools into its diagnostic offerings, while underscoring that many of its platform components remain subject to regulatory review and are not yet available for sale.