CODX
****Sponsored by TD Media, LLC
Co-Diagnostics Expands Vector Smart® Customer Reach with First International Installation in USAF Base
Co-Diagnostics Launches Integrated Cloud and Mobile Infrastructure in India
CODX has a Tight Float Under 6.5 Million
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Hello Everyone,
Co-Diagnostics, Inc. (NASDAQ: CODX) just backed up its story with hard milestones, and the picture looks even stronger now than it did a few weeks ago. The company officially submitted its Dual 510(k) premarket notification and concurrent CLIA Waiver by Application to the FDA for the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the PCR Pro® instrument, moving what was a targeted filing into an actual regulatory milestone that CEO Dwight Egan called one of the most significant in the company's history. The submission leaned on a clinical study spanning more than 1,400 symptomatic patients across nine geographically distinct U.S. sites, plus an analytical program covering 27 studies and over 10,000 test runs, including a multicenter reproducibility study that evaluated performance across multiple operators, sites and instruments to make sure the results hold up outside a controlled lab environment. If the CLIA Waiver is granted, the test could move straight into decentralized, point-of-care settings, which is exactly the kind of near-patient access the platform was built around from day one, and it would mark CODX's first cleared test on the PCR Pro instrument in the U.S. market.
On the international side, CODX flipped the switch on an integrated cloud and mobile infrastructure in India, giving its MTB clinical studies a secure, localized data backbone while laying the digital groundwork for the broader Co-Dx PCR platform to roll out across the country. The system lets results run directly on a mobile device in areas without internet access, then sync to the cloud once connectivity returns, a design built specifically for the decentralized, often disconnected settings where tuberculosis testing is needed most. The company plans to replicate that same architecture in Saudi Arabia and South Africa, effectively turning a single market deployment into a repeatable international playbook. There's a data play layered underneath it too: aggregated, anonymized results are expected to feed the company's Co-Dx Primer Ai™ platform to train machine learning models aimed at improving disease monitoring and outbreak prediction, with CODX also exploring ways to commercialize that data long-term as a standalone strategic asset. Notably, the India buildout is being supported in part by funding from the Gates Foundation, a meaningful vote of confidence in the platform's public health potential from one of the most influential funders in global health.
Manufacturing and commercial infrastructure are scaling right alongside the science. Through its CoMira Diagnostics venture, CODX secured Saudi approval for an industrial manufacturing site and signed a lease in Sudair Industrial City, setting up localized production to serve the broader Middle East and North Africa region, with an automated manufacturing line already unveiled to CoMira representatives in Utah as the company builds toward scalable output. The company also joined a European trade mission alongside the Utah Governor's Office and World Trade Center Utah, showcased its PCR platform and CE-IVD offerings at ESCMID Global 2026 to court prospective customers and distributors, presented its tuberculosis platform at the Stop TB Partnership Summit in Washington, D.C. to engage global health organizations and government agencies, and signed a distribution agreement covering Mexico to extend its reach into Latin America. Taken together, that's a company laying commercial pipe on three continents at once rather than betting everything on a single geography.
The pipeline keeps widening too. Through CoSara, CODX initiated development of a Bundibugyo virus PCR assay and advanced its pan-Ebola assay strategy, supplying Bundibugyo test kits for analytical studies in India, while separately completing a proof-of-concept study on extraction-free, plasma-based testing. That's a meaningful technical step, since it could open the platform up to blood-based diagnostics beyond its respiratory roots and give CODX a credible foothold in outbreak response for hemorrhagic fever threats, a category few small-cap diagnostics companies are positioned to address at all.
Vector Smart®, meanwhile, is turning into a growth story of its own. The division just completed two full laboratory installations in Florida and has installation and customer training underway in Indiana, timed to a sharp rise in dengue activity in the state, where health officials have logged 73 locally acquired cases across five counties and identified 14 dengue-positive mosquito pools this season. That expands a domestic network now serving 40 customers across 21 states, including seven mosquito abatement districts in Florida alone, and the platform notched its first international deployment with shipments of lab equipment, consumables and abatement materials to an overseas U.S. Air Force base, covering assays for West Nile virus, eastern and western equine encephalitis, St. Louis encephalitis, Zika, dengue and chikungunya. Management has been clear that Vector Smart was built as a scalable, multi-test surveillance platform rather than a one-off product, meaning each new lab that comes online can layer on additional pathogens as surveillance priorities shift, which supports recurring assay demand rather than a single one-time sale. An additional state public health laboratory also completed an independent evaluation of the Vector Smart VZDC assay, adding another layer of third-party validation as the network keeps expanding into new states, agencies and now international military installations.
Behind all of it, CODX brought on Wes Lindsey, Ph.D., MBA as Chief Scientific Officer to lead its scientific and regulatory strategy going forward, including future FDA submissions and continued pipeline expansion, and shored up its balance sheet with a $3.0 million at-the-market private placement to keep executing across all of these fronts at once. Between an FDA submission that's now officially in the queue, an India infrastructure rollout backed by the Gates Foundation, Middle East manufacturing coming online, a widening infectious-disease pipeline that now reaches into hemorrhagic fever territory, and a Vector Smart network expanding both domestically and internationally, CODX is stacking real, verifiable catalysts on top of that tight float under 6.5 Million. For a company this size to be checking this many boxes at once, regulatory, international, commercial and scientific, all in the span of a few weeks, is the kind of setup that tends to draw attention fast, and that's exactly why CODX belongs front and center on the radar right now.
NEWS
Co-Diagnostics Completes New Vector Smart® Laboratory Installations Amid Rising Dengue Activity in Florida
5 days ago•
Co-Diagnostics Launches Integrated Cloud and Mobile Infrastructure in India
Sep 3, 2026•
Co-Diagnostics Expands Vector Smart® Customer Reach with First International Installation in USAF Base
Sep 1, 2026•
Co-Diagnostics Participates in Medical Devices and Innovations Roundtable Media Event
Aug 18, 2026•
Co-Diagnostics Reports Second Quarter 2026 Financial Results
Aug 13, 2026•
Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test
Aug 6, 2026•
Co-Diagnostics Announces Second Quarter 2026 Earnings Release Date and Webcast
Jul 30, 2026•
Co-Diagnostics Joint Venture CoSara Provides Ebola Test Kits for Analytical Studies
Jul 28, 2026•
Co-Diagnostics Joint Venture CoSara Initiates Clinical Studies in India for Tuberculosis Test on PCR Platform
Jul 22, 2026•
Co-Diagnostics Appoints Wes Lindsey, PhD, MBA as Chief Scientific Officer
Jul 16, 2026•
MANAGEMENT
Dwight H. Egan, Chief Executive Officer
Mr. Dwight Egan has been an officer and director since April 2013. Mr. Egan has been engaged in the private investment business from February 1999 to the present. He was a senior executive at Data Broadcasting Corporation, a leading provider of wireless, real-time financial market data, news, and sophisticated fixed-income portfolio analytics to 27,000 individual and professional investors from 1995 to 1999. He co-founded and served as CEO and Chairman of the Board of Broadcast International, Inc. from 1984 to 1995 when Data Broadcasting Corporation acquired Broadcast International and created CBS MarketWatch, a leading financial news site, and participated in its initial public offering. Mr. Egan’s prior experience in directing a public company and working with capital markets gives him valuable experience in advising the board on matters of finance and operations.
Richard Abbott, President
Richard Abbott has over 25 years in senior leadership positions in in vitro diagnostics that include developing systems for infectious disease diagnosis, food pathogen monitoring, biological weapons threat detection for military and first responders, and genetics research for pharmaceutical companies and universities. As Vice President of Engineering at BioFire Diagnostics, Richard built and led highly effective cross-functional teams that developed and sold billions of dollars in revenue. Mr. Abbott holds a Master of Science degree in mechanical engineering from Brigham Young University and an M.B.A. from the Wharton Business School.
David Nielsen, Chief Operations Officer
David Nielsen joined Co-Dx in January 2022 with the acquisition of Advanced Conceptions, Inc. He has more than 25 years of R&D technical and leadership experience primarily at BioFire and BioFire Defense (formerly Idaho Technology), which was purchased by bioMérieux in 2014. As one of the original Idaho Technology employees, Mr. Nielsen worked in various roles in engineering, management, and business development. Mr. Nielsen holds a BS degree in Mechanical Engineering from Brigham Young University and both a MS in Mechanical Engineering and MBA from the University of Utah
Christopher Thurston, Chief Technology Officer
Christopher Thurston came to Co-Dx™ as the co-founder of Idaho Molecular and co-inventor of the Co-Dx PCR Pro™. He is passionate about improving human quality of life and has been instrumental in democratizing PCR diagnostics. His tenure as the principal developer and architect behind BioMerieux’s SyndromicTrends.com underscores his commitment and expertise in developing big-data solutions that advance public health. With a distinguished career that includes serving as a senior architect at Ernst and Young, senior architect at BioFire Defense, as well as executive positions at several startups, he has consistently demonstrated exceptional strategic leadership and a knack for technological innovation across a variety of sectors.
Additionally, Christopher served his country in the Army as part of the Operations in the Middle East. His military background, as well as his time living in France, has influenced his approach to the tech and biotech industries, imbuing him with a unique perspective that human health is a global problem that requires global solutions.
Seth Egan, Chief Commercialization Officer
Seth is a co-founder of Co-Diagnostics, Inc. and has led the company’s sales, marketing, and product commercialization efforts since its inception. With over 12 years of experience in the diagnostics field, Seth has played a key role in executive management of the company, including: company operations, financings, product introductions and managing (with Mohal Sarabhai) the Co-Dx/CoSara JV relationship between Co-Dx and India’s Symbiotics, LTD.
Seth participated in organizing the company’s IPO and subsequent financings. Under his guidance and in collaboration with a dedicated sales team, Co-Dx has distributed more than 35M tests to more than 50 countries, generating over $200M in revenue since 2020. Seth supervises all sales and marketing events for the company worldwide. He is eager to see the new Co-Dx PCR Pro platform make a significant impact by providing PCR tests worldwide, to both developed and emerging nations. Seth has a Bachelor of Science degree from Utah Valley University, where he majored in Business Communications.
Sincerely,
