Co-Diagnostics Inc Stock Price, News & Analysis

Co-Diagnostics (Nasdaq: CODX) performed an in silico analysis of the Co-Primers used in its Logix Smart ABC test and reported high homology against 3,900 influenza sequences, finding comparable reactivity to influenza A H3N2 subclade K (J.2.4.1).

The company noted the Logix Smart ABC test targets the MP gene while subclade K mutations occur in the HA region, and concluded no concern for reduced test sensitivity. The Logix Smart ABC test holds CE marking (November 2020) and is export-only. In November 2025 Co-Dx began clinical performance testing for a POC multiplex test intended to support a 510(k) submission to the FDA.

Co-Diagnostics (Nasdaq: CODX) announced it will present at Point-of-Care Testing 2025 in Boston on Dec. 9, 2025. The presentation, titled "Exploring the Promise of Portable, Cloud-Connected PCR Diagnostics," will describe the company's move to portable PCR devices, the upcoming Co-Dx PCR platform (including Co-Dx PCR Home and Co-Dx PCR Pro), an intuitive smartphone interface, and the integration of AI to reduce user error and improve real-time point-of-care outcomes.

The speaker session is scheduled for 11:30 AM EST at the Boston Marriott Cambridge. The summary notes the Co-Dx PCR platform and associated tests/software remain subject to FDA and other regulatory review and are not available for sale.

Co-Diagnostics (Nasdaq: CODX) announced that its JV CoSara will host a booth at VIROCON 2025 (Dec 8-10, 2025) in Pune, India and is supporting Phase II preclinical studies for Co-Dx PCR MTB (tuberculosis) and Co-Dx PCR HPV multiplex tests on the Co-Dx PCR point-of-care platform.

Key study counts: MTB Phase I used 354 clinical specimens; MTB Phase II evaluated 211 sputum specimens for concordance; HPV Phase I evaluated 286 specimens; HPV Phase II has analyzed 53 specimens to date. The company says preclinical data support advancing to clinical performance testing required by Indian regulators. The Co-Dx PCR platform remains under FDA/other regulatory review and is not yet for sale.

Co-Diagnostics (Nasdaq: CODX) addressed tuberculosis testing adoption at The Union World Conference on Lung Health on Nov 20, 2025 in Copenhagen.

The company highlighted its upcoming Co-Dx PCR Mycobacterium Tuberculosis (MTB) Test Kit and a proprietary sample-preparation instrument for point-of-care testing on the Co-Dx PCR Pro platform. Co-Dx said it is planning clinical performance testing to begin soon and anticipates potential introduction to India and South Africa, noting a target of decentralized PCR access to nearly 30,000 primary health centers in India. Management also said it is exploring a possible strategic transaction, which may include a merger with a SPAC, for its Indian joint venture CoSara Diagnostics Pvt. Ltd. The Co-Dx PCR platform is under regulatory review and not available for sale.

Co-Diagnostics (Nasdaq: CODX) has begun clinical evaluations for its Co-Dx PCR Flu A/B, COVID-19, RSV Test Kit on the compact Co-Dx PCR Pro instrument to support a U.S. FDA 510(k) submission. The company said results may also support submissions to other regulators, including the Saudi Food and Drug Authority, and plans an India introduction via joint venture CoSara Diagnostics.

The multiplex RT-PCR test simultaneously detects influenza A, influenza B, COVID-19, and RSV at point-of-care; the Co-Dx PCR platform remains under regulatory review and is not available for sale.

Co-Diagnostics (NASDAQ: CODX) reported third quarter 2025 results for the period ended September 30, 2025. Key metrics: revenue $0.1M versus $0.6M in Q3 2024, operating expense ~$7.1M (down 32.6% YoY), operating loss $7.0M, net loss $5.9M or $0.16 per diluted share, and adjusted EBITDA loss $6.3M. Cash and marketable securities totaled $11.4M at quarter end. Material corporate actions: closed a Registered Direct Offering for approximately $3.8M in-quarter and a subsequent RDO of approximately $7.0M, and signed a definitive JV agreement to commercialize Co-Dx technologies in KSA and 18 MENA nations (CoMira Diagnostics). The company also launched an AI business unit, developed a PoC sample-prep instrument for MTB testing, and plans NIH-supported clinical evaluations for an upper-respiratory multiplex test.

Co-Diagnostics (Nasdaq: CODX) was recognized by Utah Governor Spencer Cox and BioUtah following its announced formation of CoMira Diagnostics, a joint venture in the Kingdom of Saudi Arabia on Nov 12, 2025. The company is described as a Utah-born diagnostics firm with a patented platform for molecular diagnostic tests.

The acknowledgment highlights Co-Diagnostics' announced expansion across the Middle East and North Africa and its signing of a definitive JV agreement in the Kingdom of Saudi Arabia, which BioUtah said confirms the company’s growing global presence.

Co-Diagnostics (NASDAQ: CODX) announced on November 5, 2025 that it has engaged Maxim Group as exclusive financial advisor to explore strategic alternatives for its Indian joint venture, CoSara Diagnostics Pvt. Ltd.

Options being pursued include a merger with a SPAC or similar U.S.-listed entity on a national securities exchange. CoSara, established in 2017, is a joint venture between Co-Diagnostics and Synbiotics, part of Asence and Ambalal Sarabhai Enterprises (Bombay Stock Exchange-listed). CoSara intends to manufacture and sell molecular diagnostics products with an initial focus on India and certain international markets.

Co-Diagnostics (Nasdaq: CODX) announced the formation of a new artificial intelligence business unit, led by Chief Technology & AI Officer Christopher Thurston, to consolidate the company’s AI initiatives into the Co-Dx Primer Ai platform.

The company said the unit aims to accelerate development of proprietary AI-powered PCR diagnostics, support Co-Primers design and workflow orchestration, enable automated test interpretation, and integrate analytics via a HIPAA-compliant Co-Dx cloud. The release notes the Co-Dx PCR platform remains subject to FDA and other regulatory review and is not available for sale.