Co-Diagnostics, Inc. reports developments in molecular diagnostics, including its patented platform for designing molecular diagnostic tests and its Co-Dx PCR platform. Company news commonly covers clinical and regulatory disclosures, commercialization activity through CoSara and CoMira joint ventures, intellectual property and technology updates, and operating and financial results.
Recurring updates also include material agreements, governance matters, capital-structure actions, and securities-listing developments. The company’s public disclosures connect its diagnostic-test pipeline, platform development, and commercialization strategy with financing, shareholder approvals, and other corporate actions.
Co-Diagnostics (Nasdaq: CODX) will release its third-quarter 2026 financial results after market close on November 10, moving up its reporting date. The release was previously scheduled for November 12, 2026. A conference call and webcast will follow on November 10 at 4:30 p.m. ET, with a recording later available on the company's website.
Co-Diagnostics (Nasdaq: CODX) will participate in three global tuberculosis events in November 2026 as its Indian joint venture advances toward launch.
The events are the Stop TB Partnership Board Meeting and related events on November 3–6 in Bali, Indonesia; the New Tools Summit on November 16 in Rio de Janeiro, Brazil; and the Union World Conference on Lung Health on November 17–20 in Rio de Janeiro.
CoSara, the company's Indian joint venture, is moving toward commercial launch of its PCR Mycobacterium tuberculosis test. The CoSara PCR Pro instrument and associated tests remain subject to applicable regulatory review and authorization. They have not been cleared or approved by the US FDA and are not available for sale in the United States.
Co-Diagnostics (CODX) will release its third quarter 2026 financial results after the market close on November 12, 2026. A conference call and webcast will follow at 4:30 p.m. ET, featuring CEO Dwight Egan and Executive Vice President of Finance and Accounting Daniel Bohrer. A recording will later be available on the company's website.
Co-Diagnostics (CODX) announced publication of a peer-reviewed HPV screening study using the SARAGENE test manufactured by its Indian joint venture, CoSara Diagnostics.
Investigators screened 625 women aged 30 to 60 in Central Gujarat, India; 20 tested positive for high-risk HPV. Among those women, 18 had negative cytology results and two had low-grade abnormalities. Follow-up biopsies identified high-grade cervical lesions in nine women and invasive cervical cancer in three. Published in Infectious Agents and Cancer, the findings are preliminary because of the study design and limited HPV-positive sample; larger studies are needed for confirmation.
SARAGENE is authorized for testing in India and unavailable for sale in the United States. Co-Diagnostics is developing a separate HPV test for its Co-Dx PCR Pro platform; neither that platform nor its HPV test was evaluated in this study.
Co-Diagnostics (CODX) announced that its Indian joint venture, CoSara Diagnostics, completed a tuberculosis test clinical study and submitted it for regulatory clearance. The study assessed 676 clinical samples, including 233 paired with MGIT testing that formed the comparative performance results. Across three batches, average sensitivity was 97.3%, measuring detection of TB-positive samples, and average specificity was 96.0%, measuring identification of negative samples.
The application is under review by India's Central Drugs Standard Control Organization, which may impose additional requirements. Co-Diagnostics and CoSara expect approval in Q4 2026, positioning CoSara to begin Indian commercial sales before year-end. Mobile and cloud infrastructure has been deployed in India to support the anticipated launch. Sales remain dependent on regulatory clearance.
Co-Diagnostics (CODX) announced that its Saudi joint venture, CoMira Diagnostics, has been invited to participate in the NUWATIN forum in November 2026. Saudi Arabia's Ministry of Industry and Mineral Resources extended the invitation to CoMira, the joint venture with Arabian Eagle Manufacturing.
CoMira has executed a lease for a planned manufacturing facility in Sudair Industrial City. It plans to establish molecular diagnostics manufacturing in Saudi Arabia, including localization of Co-Diagnostics' PCR technologies. CoMira intends to use the forum to engage government and industry stakeholders on technology transfer and local manufacturing. Co-Diagnostics believes domestic production may offer advantages in government procurement that prioritizes locally manufactured healthcare products. The Co-Dx PCR platform remains subject to regulatory review and is not yet available for sale.
Co-Diagnostics (Nasdaq: CODX) highlighted its PCR platform’s potential application to plague diagnostics if a public health need arises. No plague-specific test development has begun, and the company is not announcing a new development program.
The company believes its sputum sample-preparation experience from tuberculosis testing could support a response. Instruments and tuberculosis test kits have been deployed to select laboratories in India, where joint venture CoSara’s clinical studies are underway. A separate collaboration with ReadyGo is evaluating sample preparation for Ebola detection; feasibility work remains at an early stage. The Co-Dx PCR platform has not been cleared or authorized by the FDA and is not yet available for sale.
Co-Diagnostics (CODX) received an order from the Ute Indian Tribe Mosquito Abatement Department for a complete Vector Smart laboratory installation.
The order marks the company's first complete Vector Smart laboratory installation for a Native American tribe. The planned installation will enable the department to test mosquito pools in house using PCR, a method for detecting genetic material. The Tribe is located on the Uintah and Ouray Reservation in northeastern Utah. Local molecular testing will provide surveillance data to support mosquito-control decisions.
Co-Diagnostics (CODX) highlighted its Vector Smart mosquito surveillance business following a federal initiative addressing mosquito- and tick-borne diseases. Executive Order 14433, signed September 29, 2026, directs the U.S. Department of Health and Human Services to pursue rapid-diagnostic prize competitions or research and development programs within 90 days.
Vector Smart has served 40 customers across 21 U.S. states since launch. In September 2026, the company completed its first international deployment through an order from an overseas U.S. Air Force base, also its first Air Force order. Recent milestones include an additional independent state public health laboratory evaluation of its VZDC assay. The company plans stakeholder engagement at an October 9 roundtable and four regional vector-control conferences.
Co-Diagnostics (CODX) will showcase its Co-Dx PCR platform and MTB test at WHX Labs Johannesburg on October 6–8, 2026.
The company is optimizing the sensitivity of an Ebola assay in development for use on the platform in decentralized testing settings and is pursuing grants and other funding to advance that work. The MTB test was developed for molecular tuberculosis testing in decentralized settings. The platform and associated tests have not been cleared or authorized by the FDA, remain subject to regulatory review and are not yet available for sale.