Co-Diagnostics Inc Stock Price, News & Analysis

Co-Diagnostics (OTC: CODX) joint venture CoSara received a CDSCO Form MD-5 license on Feb 5, 2026, authorizing manufacture of the CoSara PCR Pro real-time PCR point-of-care instrument at its Ranoli, India facility for sale or distribution.

This instrument license is described as the final CDSCO instrument approval required before commercialization; the CoSara-branded PCR Pro will be manufactured and distributed in India and run with CoSara PCR test kits, which require separate regulatory clearance prior to use as IVDs.

Co-Diagnostics (OTC: CODX) said its joint venture CoSara has received ISO 13485:2016 certification for its Vadodara, India manufacturing facility on Feb 4, 2026. The certification validates the joint venture's quality management system and supports regulatory submissions for an upcoming PCR platform and associated tests.

Company staff visited India to finalize MTB and HPV test software, inspect clinical study sites, and support manufacturing lines; the PCR platform remains subject to FDA and other regulatory review and is not yet for sale.

Co-Diagnostics (Nasdaq: CODX) said its Indian joint venture CoSara Diagnostics expanded distributor engagement by exhibiting at two regional conferences (GAPM in Gujarat on Jan 10-11 and ACLAP in Maharashtra) and has an existing network of over 40 distributors across India.

CoSara is preparing to assist in clinical performance studies for the Co-Dx PCR Mycobacterium Tuberculosis (MTB) Test on the Co-Dx PCR platform and will participate in manufacturing the PCR Pro instrument and MTB test cups to align with India’s "Make in India" initiative. The Co-Dx PCR platform remains subject to review by the FDA and other regulators and is not yet available for sale.

Co-Diagnostics (Nasdaq: CODX) filed a Certificate of Amendment to effect a 1-for-30 reverse stock split, effective at 12:01 a.m. ET on January 2, 2026. The company's common stock will continue trading on Nasdaq under the symbol CODX and will trade on a split-adjusted basis when markets open on January 2, 2026. The reverse split was approved by stockholders at a special meeting on December 5, 2025 within an authorized range of 1-for-2 to 1-for-30.

The reverse split is intended to enable the company to regain compliance with Nasdaq's $1.00 minimum bid price requirement. At the effective time, every 30 issued and outstanding shares will combine into one share; par value per share remains unchanged. The action will adjust shares available under equity incentive plans, change option and warrant share counts and increase exercise prices, and result in a new CUSIP of 189763 204. Fractional shares will be rounded up to the next whole share.

Co-Diagnostics (Nasdaq: CODX) announced that the Australian Patent Office granted Australian Patent No. AU2022270084A1, strengthening IP around its Co-Dx PCR platform.

The patent, filed in May 2022 and granted in June 2025, covers the design and operation of the Co-Dx PCR Pro instrument and test cups and protects the company’s Co-Primers® approach for nucleic acid detection. The grant provides regional protection in Australia as the company advances a Co-Dx PCR Flu A/B, COVID, RSV multiplex test currently in clinical performance testing. The platform remains under FDA/other regulatory review and is not yet for sale.

Co-Diagnostics (Nasdaq: CODX) said its joint venture CoSara Diagnostics was invited to the 2nd Advanced TB Diagnostics Course in Chennai, India, held Dec 15–19, 2025 at ICMR–NIRT.

The multi-day workshop, hosted with McGill International TB Centre and global partners, brings national TB programs, diagnostics developers, industry and experts from WHO, Gates Foundation, FIND and academic institutions to review the diagnostics value chain, new technologies, cost-effectiveness modeling, policy development and strategies to close the TB case-finding gap across the South‑East Asian Region.

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.