Co-Diagnostics Stock Surges 81% After Class Action Dismissal and PCR Pipeline Milestones

Introduction

Co-Diagnostics, Inc. (NASDAQ: CODX) is a Salt Lake City-based molecular diagnostics company founded in 2013. The firm develops, manufactures, and markets real-time polymerase chain reaction (PCR) technologies that detect nucleic acid molecules (DNA/RNA). Its proprietary Co-Primers® chemistry underpins both at-home and point-of-care platforms, enabling rapid amplification and detection of viruses and other genetic markers in under 30 minutes with devices suitable for various settings.

Corporate Structure

As of mid-2025, Co-Diagnostics employs between 51 and 200 staff across research, manufacturing, regulatory, and commercial functions. Dwight Egan serves as Chief Executive Officer, overseeing the strategic development of the Co-Dx PCR Home™ and PCR Pro™ platforms, while Brian Brown, as Chief Financial Officer, manages financial planning and investor relations. The company is headquartered in Salt Lake City, Utah, and is publicly traded on the Nasdaq Stock Market under ticker CODX.

PCR Technology by Growtika

Recent Developments and News

• Class Action Dismissal (March 6, 2025): In Gelt Trading, Ltd. v. Co-Diagnostics, Inc., the U.S. District Court for the District of Utah granted summary judgment in favor of Co-Diagnostics, dismissing a Section 10(b) securities class action related to the May 1, 2020, release on Logix Smart® COVID-19 test performance.
• First Quarter 2025 Results (May 8, 2025): The company reported progress on its test pipeline and reiterated its focus on clinical evaluations and regulatory submissions for tuberculosis, respiratory multiplex, HPV multiplex, and COVID-19 assays on the upcoming Co-Dx PCR Pro™ instrument. A conference call was held to discuss these developments.
• SEC Filings (August 14, 2025): Co-Diagnostics filed its Form 10-Q covering quarterly performance metrics and two Form 8-Ks detailing updates on operations under Items 2.02, 7.01, and 9.01, as well as a separate Item 8.01 disclosure.
• Industry Recognition (June 2025): At the Utah Business 2025 Awards Summit, Co-Diagnostics was recognized in the Healthcare & Life Sciences category for its Co-Dx PCR platform. CEO Egan accepted the award, emphasizing the company’s mission to improve access to PCR point-of-care testing.

Financial and Strategic Analysis

On September 16, 2025, CODX was trading at $0.6399 per share, reflecting an 81.07% increase over its prior closing price, with trading volume at 45,449,073 shares. This price movement followed the March 6 dismissal of the class action, which released the company from associated litigation concerns. In Q1 2025, management underscored ongoing research and development investments, targeting four core assays—tuberculosis, respiratory multiplex, HPV multiplex, and COVID-19—designed for the PCR Pro™ platform. The company’s adjusted EBITDA, which excludes non-cash stock-based compensation and certain one-time items, is intended to provide investors with insights into its operational performance.

Strategically, Co-Diagnostics is focusing on:

• Regulatory Milestones: Submissions to the U.S. Food and Drug Administration and international bodies for clinical evaluations of its new assays.
• Commercial Rollout: Finalizing the manufacturing scale-up for the Co-Dx PCR Home™ and PCR Pro™ instruments.
• Partnerships: Collaborating with CoSara Diagnostics Pvt. Ltd. on oncology diagnostics and engaging with public health entities in vector control testing.

Market Position and Industry Context

Co-Diagnostics operates in the global molecular diagnostics market, estimated at over $12 billion in 2025. Its platform competes with established players, such as Roche’s TaqMan® assays, by emphasizing portability, speed, and affordability. To date, Co-Diagnostics has sold more than 34 million real-time PCR tests worldwide. The company’s focus on point-of-care and at-home testing aligns with increasing demand for decentralized diagnostics in infectious disease management, tuberculosis control, and vector-borne virus surveillance, particularly in areas with limited laboratory infrastructure.

tl;dr

On March 6, 2025, Co-Diagnostics secured the dismissal of a securities class action, addressing a significant legal issue. The May 8, 2025, Q1 report detailed progress toward four core assays and ongoing regulatory submissions for its Co-Dx PCR Pro™ platform. As of September 16, 2025, CODX shares were at $0.6399—a rise of 81.07%—attributed to pipeline advancements and improved market sentiment. Upcoming catalysts include clinical evaluation results, regulatory approvals, and initial commercial deployments of the PCR Home™ and PCR Pro™ systems.