Co-Diagnostics (NASDAQ:CODX) said its joint venture has submitted a point-of-care tuberculosis test for regulatory review in India after completing a clinical performance study, while a separate U.S. application for its flu and respiratory syncytial virus test remains under review.
Chief Executive Officer Dwight Egan said on the company’s third-quarter earnings webcast that CoSara Diagnostics submitted the final clinical study report for the CoSara PCR MTB test to India’s Central Drugs Standard Control Organisation, or CDSCO. The submission is one of two regulatory applications the company has under review.
Co-Diagnostics also reported lower operating expenses for the quarter and reduced operating cash use for the first nine months of 2026. Management discussed the results in prepared remarks only; the webcast did not include a question-and-answer session.
TB study completed in India
The tuberculosis study evaluated the CoSara PCR MTB test on the CoSara PCR Pro instrument across selected laboratories in India. In samples paired with MGIT liquid culture, which Egan described as the reference standard for TB detection, the test showed average sensitivity of approximately 97.3% and average specificity of approximately 96% across three lots.
Egan said India accounts for approximately one-quarter of the world’s tuberculosis cases, citing the World Health Organization’s Global Tuberculosis Report 2025. He also cited WHO estimates that 10.7 million people globally fell ill with TB and 1.23 million died from it in 2024.
In the U.S., Co-Diagnostics submitted a dual 510(k) and CLIA Waiver by Application to the Food and Drug Administration in August for its Flu A/B & RSV test on the Co-Dx PCR platform. The application remains under review, Egan said. The company said the platform requires regulatory approval and marketing authorization for diagnostic use and is not currently for sale.
Blood-testing collaboration and connected platform
Co-Diagnostics announced a collaboration in September with U.K.-based ReadyGo Diagnostics to evaluate blood-based molecular testing at the point of need, initially focusing on decentralized Ebola detection and outbreak response. Egan said the Co-Dx PCR platform has been designed around swab-based samples, and the work will evaluate whether blood can be added as a compatible sample type.
The collaboration follows a July proof-of-concept study in which an extraction-free Co-Primers Ebola assay using diluted plasma ran on the PCR Pro. Co-Diagnostics has received ReadyGo materials and devices under a material transfer agreement, and feasibility work is underway. Egan cautioned that the collaboration is non-exclusive and early-stage and that compatibility between the technologies has not been established.
The company also launched integrated cloud and mobile infrastructure in India in September to support its TB clinical work. Egan said results can be analyzed on a mobile device without an internet connection and synchronized to the cloud when connectivity is available. The deployment is supported in part by Gates Foundation funding.
Vector Smart deployment and financial results
Co-Diagnostics completed its first international deployment of the Vector Smart platform through an order from an overseas U.S. Air Force base in September. Egan said the platform has served approximately 40 domestic customers across 21 states.
During the quarter, the company completed two laboratory installations in Florida and began installation and customer training in Indiana. After quarter-end, the Ute Indian Tribe Mosquito Abatement Department in northeastern Utah ordered a full Vector Smart laboratory installation, Egan said.
Third-quarter operating expenses fell to $6.2 million from $7.1 million a year earlier, a decrease of 12%. Net cash used in operating activities was $20.7 million for the first nine months of 2026, compared with $22.9 million in the same period of 2025.
About Co-Diagnostics (NASDAQ:CODX)
Co-Diagnostics, Inc. is a molecular diagnostics company that develops and commercializes diagnostic tests and laboratory technologies. Based in Salt Lake City, Utah, the company focuses on assays that detect genetic material from infectious diseases and other medical conditions. The company’s core technology is its CoPrimer platform, which is designed to support the development of molecular tests using specialized primer technology. Products associated with the platform include the Logix Smart line of real-time polymerase chain reaction (PCR) assays, covering applications such as respiratory and other infectious diseases.
