Co-Diagnostics Completes Clinical Performance Studies for PCR Test
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jul 01 2026
0mins
Source: Newsfilter
- Clinical Study Completion: Co-Diagnostics has completed clinical and analytical performance studies for the Co-Dx™ PCR Flu A/B and RSV upper respiratory multiplex test across 9 clinical sites, enrolling over 1,400 patients, marking a significant milestone towards the FDA submission for 510(k) and CLIA Waiver.
- Analytical Validation Data: The studies included 27 individual analytical studies and over 10,000 PCR test cup runs, providing robust evidence to support the upcoming FDA submission targeted for Q3 2026, showcasing the company's potential in the decentralized testing market.
- Reproducibility Study: An external multicenter reproducibility study demonstrated consistent performance across different operators, sites, and instruments, meeting CLIA Waiver requirements and enhancing the product's competitive edge in the market.
- Strategic Vision: CEO Dwight Egan emphasized that the platform aims to deliver accurate near-patient PCR diagnostics, and the company's ongoing efforts and forthcoming submission will lay the groundwork for future commercialization, promoting the adoption of decentralized healthcare.
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About CODX
Co-Diagnostics, Inc. is a molecular diagnostics company, which develops, manufactures and markets diagnostics technologies. The Company’s technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR platform and to locate genetic markers for use in applications other than infectious disease. Its diagnostics systems enable dependable, low-cost, molecular testing for organisms and genetic diseases by automating or simplifying historically complex procedures in both the development and administration of tests. It is developing a portable diagnostic device and test system designed for point-of-care and at-home use. The system consists of its PCR instrument that it refers to as the Co-Dx PCR Pro instrument, its proprietary diagnostic test cup system and a mobile application to be installed on the user’s mobile device.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Co-Diagnostics Joins Global TB Diagnostics Workshop
- Global Collaboration Opportunity: Co-Diagnostics has been invited to participate in the Global Implementation Workshop in Bangkok, Thailand, which brings together national TB programs, researchers, and technical agencies from 21 countries to share early implementation experiences with near-point-of-care (NPOC) platforms, thereby advancing global TB diagnostic policies and operational plans.
- Technology Showcase: At the workshop, Co-Diagnostics will demonstrate its Co-Dx™ PCR platform and Co-Dx PCR MTB test to representatives from over 50 organizations, providing hands-on experience and facilitating discussions with the Co-Dx team, further promoting the global application of its technology.
- WHO Guideline Support: Recent guidance from the World Health Organization underscores the importance of expanding near-point-of-care molecular diagnostics for tuberculosis, and the design of the Co-Dx PCR platform aligns with these updated global diagnostic recommendations, integrating sample preparation, amplification, and detection in decentralized testing environments.
- Market Potential: Although the Co-Dx PCR platform is not yet available for sale, its potential applications and market demand in global TB diagnostics, especially for patients unable to provide sputum samples, indicate significant commercial opportunities and strategic importance.
See More
Co-Diagnostics Joins Global TB Diagnostics Workshop
- Global Collaboration Opportunity: Co-Diagnostics has been invited to participate in the Global Implementation Workshop in Bangkok, Thailand, which brings together national TB programs, researchers, and donors from 21 countries to share early implementation experiences with near-point-of-care TB diagnostics, thereby advancing the adoption of new WHO guidelines.
- Technology Showcase: The workshop will provide hands-on experience with the Co-Dx™ PCR platform and Co-Dx PCR MTB test for representatives from over 50 organizations, facilitating in-depth discussions with the Co-Dx team and enhancing the company's influence in the global TB diagnostics arena.
- Policy Translation Support: The workshop aims to translate the new WHO guidelines on near-point-of-care diagnostics into national policies and operational plans, assisting countries in preparing NPOC components for their Global Fund GC8 funding requests, thus improving global TB testing capabilities.
- Integration Advantage: The Co-Dx PCR platform is designed to integrate sample preparation, amplification, and detection into a single workflow suitable for decentralized testing environments, aligning with the latest recommendations for global TB diagnostics, showcasing the company's innovative potential in molecular diagnostics.
See More
Co-Diagnostics Completes Clinical Performance Studies for PCR Test
- Clinical Study Completion: Co-Diagnostics has completed clinical and analytical performance studies for the Co-Dx™ PCR Flu A/B and RSV upper respiratory multiplex test across 9 clinical sites, enrolling over 1,400 patients, marking a significant milestone towards the FDA submission for 510(k) and CLIA Waiver.
- Analytical Validation Data: The studies included 27 individual analytical studies and over 10,000 PCR test cup runs, providing robust evidence to support the upcoming FDA submission targeted for Q3 2026, showcasing the company's potential in the decentralized testing market.
- Reproducibility Study: An external multicenter reproducibility study demonstrated consistent performance across different operators, sites, and instruments, meeting CLIA Waiver requirements and enhancing the product's competitive edge in the market.
- Strategic Vision: CEO Dwight Egan emphasized that the platform aims to deliver accurate near-patient PCR diagnostics, and the company's ongoing efforts and forthcoming submission will lay the groundwork for future commercialization, promoting the adoption of decentralized healthcare.
See More
Co-Diagnostics Expands Mosquito Abatement Customer Base
- Customer Base Growth: Co-Diagnostics has expanded its mosquito abatement district customer base to 21 states, with four new full laboratory installations added in June, reflecting the strength of its technology and the urgent need for vector-borne disease surveillance.
- Technological Advantage: The company's Vector Smart® product line includes multiplex PCR tests for various diseases such as West Nile virus and Zika, designed to enhance situational awareness in communities and improve abatement efficiency.
- Market Demand: According to the World Health Organization, vector-borne diseases cause over 700,000 deaths annually, and Co-Diagnostics' technology enables decentralized PCR testing within communities, facilitating better coordination among public health agencies.
- Commitment to Innovation: The company is committed to remaining at the forefront of decentralized PCR technology to support global vector control and infectious disease testing, ensuring timely collection and sharing of surveillance data to protect community health.
See More
Co-Diagnostics Advances Technology Transfer with CoMira Partnership
- Technology Transfer Initiative: Co-Diagnostics' delegation from CoMira Diagnostics visited the Salt Lake City headquarters, marking a new phase in the planned technology transfer that is expected to enhance diagnostic test production capabilities in Saudi Arabia and 18 other Middle Eastern and North African countries.
- Automated Production Line Unveiling: During the visit, Co-Diagnostics unveiled its future automated PCR test kit manufacturing line, a critical facility that will support rapid scaling of diagnostic test production to meet local healthcare needs and improve operational efficiency.
- Significance of International Collaboration: CEO Dwight Egan emphasized that the partnership with CoMira reflects the belief that closing the diagnostics gap requires a blend of cutting-edge technology and local expertise, aiming to enhance diagnostic accessibility across the region.
- AI-Integrated Platform: The Co-Dx PCR platform integrates artificial intelligence and cloud-connected outbreak surveillance capabilities, which are expected to be part of the CoMira partnership, reflecting the company's strategic intent to deploy automated, AI-driven diagnostic infrastructure in key international markets.
See More
Co-Diagnostics Advances Technology Transfer with CoMira Partnership
- Technology Transfer Initiative: Co-Diagnostics is set to transfer its molecular diagnostics platform and manufacturing capabilities to CoMira Diagnostics in Saudi Arabia, which is expected to significantly enhance diagnostic test production capacity in the region to meet healthcare needs.
- Automated Production Line Unveiling: The unveiling of the future automated PCR test kit manufacturing line at the Salt Lake City headquarters will support rapid scaling of diagnostic test production, anticipated to provide efficient testing solutions for Saudi Arabia and 18 other Middle Eastern and North African countries.
- Significance of International Collaboration: CEO Dwight Egan emphasized that international partnerships are crucial for closing the diagnostics gap, showcasing the company's strategy of combining cutting-edge technology with local expertise to enhance diagnostic accessibility in the region.
- AI-Integrated Platform: The Co-Dx PCR platform integrates artificial intelligence and cloud-connected outbreak surveillance capabilities designed for real-time monitoring of infectious disease trends, expected to be a component of the CoMira partnership, reflecting the company's broader strategy of deploying automated, AI-enabled diagnostics infrastructure in key international markets.
See More
Co-Diagnostics Joins Global TB Diagnostics Workshop
- Global Collaboration Opportunity: Co-Diagnostics has been invited to participate in the Global Implementation Workshop in Bangkok, Thailand, which brings together national TB programs, researchers, and technical agencies from 21 countries to share early implementation experiences with near-point-of-care (NPOC) platforms, thereby advancing global TB diagnostic policies and operational plans.
- Technology Showcase: At the workshop, Co-Diagnostics will demonstrate its Co-Dx™ PCR platform and Co-Dx PCR MTB test to representatives from over 50 organizations, providing hands-on experience and facilitating discussions with the Co-Dx team, further promoting the global application of its technology.
- WHO Guideline Support: Recent guidance from the World Health Organization underscores the importance of expanding near-point-of-care molecular diagnostics for tuberculosis, and the design of the Co-Dx PCR platform aligns with these updated global diagnostic recommendations, integrating sample preparation, amplification, and detection in decentralized testing environments.
- Market Potential: Although the Co-Dx PCR platform is not yet available for sale, its potential applications and market demand in global TB diagnostics, especially for patients unable to provide sputum samples, indicate significant commercial opportunities and strategic importance.
See More
Co-Diagnostics Joins Global TB Diagnostics Workshop
- Global Collaboration Opportunity: Co-Diagnostics has been invited to participate in the Global Implementation Workshop in Bangkok, Thailand, which brings together national TB programs, researchers, and donors from 21 countries to share early implementation experiences with near-point-of-care TB diagnostics, thereby advancing the adoption of new WHO guidelines.
- Technology Showcase: The workshop will provide hands-on experience with the Co-Dx™ PCR platform and Co-Dx PCR MTB test for representatives from over 50 organizations, facilitating in-depth discussions with the Co-Dx team and enhancing the company's influence in the global TB diagnostics arena.
- Policy Translation Support: The workshop aims to translate the new WHO guidelines on near-point-of-care diagnostics into national policies and operational plans, assisting countries in preparing NPOC components for their Global Fund GC8 funding requests, thus improving global TB testing capabilities.
- Integration Advantage: The Co-Dx PCR platform is designed to integrate sample preparation, amplification, and detection into a single workflow suitable for decentralized testing environments, aligning with the latest recommendations for global TB diagnostics, showcasing the company's innovative potential in molecular diagnostics.
See More
Co-Diagnostics Completes Clinical Performance Studies for PCR Test
- Clinical Study Completion: Co-Diagnostics has completed clinical and analytical performance studies for the Co-Dx™ PCR Flu A/B and RSV upper respiratory multiplex test across 9 clinical sites, enrolling over 1,400 patients, marking a significant milestone towards the FDA submission for 510(k) and CLIA Waiver.
- Analytical Validation Data: The studies included 27 individual analytical studies and over 10,000 PCR test cup runs, providing robust evidence to support the upcoming FDA submission targeted for Q3 2026, showcasing the company's potential in the decentralized testing market.
- Reproducibility Study: An external multicenter reproducibility study demonstrated consistent performance across different operators, sites, and instruments, meeting CLIA Waiver requirements and enhancing the product's competitive edge in the market.
- Strategic Vision: CEO Dwight Egan emphasized that the platform aims to deliver accurate near-patient PCR diagnostics, and the company's ongoing efforts and forthcoming submission will lay the groundwork for future commercialization, promoting the adoption of decentralized healthcare.
See More
Co-Diagnostics Expands Mosquito Abatement Customer Base
- Customer Base Growth: Co-Diagnostics has expanded its mosquito abatement district customer base to 21 states, with four new full laboratory installations added in June, reflecting the strength of its technology and the urgent need for vector-borne disease surveillance.
- Technological Advantage: The company's Vector Smart® product line includes multiplex PCR tests for various diseases such as West Nile virus and Zika, designed to enhance situational awareness in communities and improve abatement efficiency.
- Market Demand: According to the World Health Organization, vector-borne diseases cause over 700,000 deaths annually, and Co-Diagnostics' technology enables decentralized PCR testing within communities, facilitating better coordination among public health agencies.
- Commitment to Innovation: The company is committed to remaining at the forefront of decentralized PCR technology to support global vector control and infectious disease testing, ensuring timely collection and sharing of surveillance data to protect community health.
See More
Co-Diagnostics Advances Technology Transfer with CoMira Partnership
- Technology Transfer Initiative: Co-Diagnostics' delegation from CoMira Diagnostics visited the Salt Lake City headquarters, marking a new phase in the planned technology transfer that is expected to enhance diagnostic test production capabilities in Saudi Arabia and 18 other Middle Eastern and North African countries.
- Automated Production Line Unveiling: During the visit, Co-Diagnostics unveiled its future automated PCR test kit manufacturing line, a critical facility that will support rapid scaling of diagnostic test production to meet local healthcare needs and improve operational efficiency.
- Significance of International Collaboration: CEO Dwight Egan emphasized that the partnership with CoMira reflects the belief that closing the diagnostics gap requires a blend of cutting-edge technology and local expertise, aiming to enhance diagnostic accessibility across the region.
- AI-Integrated Platform: The Co-Dx PCR platform integrates artificial intelligence and cloud-connected outbreak surveillance capabilities, which are expected to be part of the CoMira partnership, reflecting the company's strategic intent to deploy automated, AI-driven diagnostic infrastructure in key international markets.
See More
Co-Diagnostics Advances Technology Transfer with CoMira Partnership
- Technology Transfer Initiative: Co-Diagnostics is set to transfer its molecular diagnostics platform and manufacturing capabilities to CoMira Diagnostics in Saudi Arabia, which is expected to significantly enhance diagnostic test production capacity in the region to meet healthcare needs.
- Automated Production Line Unveiling: The unveiling of the future automated PCR test kit manufacturing line at the Salt Lake City headquarters will support rapid scaling of diagnostic test production, anticipated to provide efficient testing solutions for Saudi Arabia and 18 other Middle Eastern and North African countries.
- Significance of International Collaboration: CEO Dwight Egan emphasized that international partnerships are crucial for closing the diagnostics gap, showcasing the company's strategy of combining cutting-edge technology with local expertise to enhance diagnostic accessibility in the region.
- AI-Integrated Platform: The Co-Dx PCR platform integrates artificial intelligence and cloud-connected outbreak surveillance capabilities designed for real-time monitoring of infectious disease trends, expected to be a component of the CoMira partnership, reflecting the company's broader strategy of deploying automated, AI-enabled diagnostics infrastructure in key international markets.
See More
