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Co-Diagnostics, Inc. Common Stock

Co-Diagnostics, Inc. is a molecular diagnostics company that develops, manufactures, and sells reagents for diagnostic tests based on the detection and analysis of nucleic acid molecules. It offers the Co-Dx PCR platform for polymerase chain reaction testing in point-of-care and at-home settings. The company provides PCR diagnostic tests for COVID-19, influenza, tuberculosis, hepatitis B and C, malaria, dengue, human papillomavirus, chikungunya, and Zika virus. It also offers three multiplexed tests for identifying diseases carried by mosquitoes, molecular tools for infectious disease detection, tests for genetic traits in plant and animal genomes, and a portable diagnostic device for point-of-care and at-home PCR testing. Co-Diagnostics was incorporated in 2013 and is based in Salt Lake City, Utah.

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Biotech & Genomic Medicine

Co-Diagnostics and ReadyGo to Evaluate Blood-Based Molecular Testing, Starting with Ebola

Co-Diagnostics, Inc. and ReadyGo Diagnostics Ltd. announced a collaboration to evaluate the potential use of ReadyGo's sample-preparation technology with the Co-Dx PCR platform for blood-based molecular testing at the point of need, with an initial focus on decentralized Ebola virus detection and outbreak response. The companies are evaluating two potentially complementary technologies: the Co-Dx PCR platform, a point-of-need PCR technology, and GoCollect by ReadyGo, a field sample-preparation system that prepares blood samples for molecular testing at the point of need. The collaboration builds on Co-Dx's earlier proof-of-concept work testing an Ebola assay using plasma as a sample type, and establishing blood as a compatible sample type would extend the Co-Dx PCR platform beyond the swab-based testing it supports today into bloodborne pathogens such as HIV and hepatitis B and C. The companies have begun feasibility work and Co-Dx has taken delivery of ReadyGo materials and devices to support that evaluation, though there can be no assurance that the evaluation will be successful or result in a commercially available product. In the ongoing outbreak in the Democratic Republic of the Congo, the World Health Organization has reported 6,757 confirmed cases and 3,267 deaths as of Sept 7, 2026, for a case fatality rate of approximately 48%, with 61 health zones affected across six provinces, and the WHO has described this as the second-largest Ebola outbreak on record. Co-Dx will host a live press conference and webcast on Wednesday, September 16, 2026, at 10:30 a.m. ET to discuss the collaboration.
PR Newswire·2dRead more →
CODX

Co-Diagnostics submits dual FDA application as cash falls to $3.6M

Co-Diagnostics has officially submitted a dual 510(k) and CLIA waiver application to the FDA for its flu A, B and RSV assay on the Co-Dx PCR platform. The company reported second quarter 2026 revenue of $166,000 and a net loss of $6.3 million, or $1.46 per share, while cash and cash equivalents fell to $3.6 million. Management also announced the hiring of Dr. Wes Lindsey as Chief Scientific Officer and said it is targeting additional regulatory milestones later this year, including planned submissions to India's CDSCO and the World Health Organization's Expert Review Panel for Diagnostics for its tuberculosis test. CFO Brian Brown said the company expects to continue evaluating sources of capital, which may include equity or debt financings, strategic transactions and partnerships.
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