Welcome to our dedicated page for Co-Diagnostics news (Ticker: CODX), a resource for investors and traders seeking the latest updates and insights on Co-Diagnostics stock.
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) announced submission of a Dual FDA 510(k) premarket notification, together with a concurrent CLIA Waiver by Application, for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test to be used on the Co-Dx PCR Pro instrument in decentralized point-of-care settings.
According to Co-Diagnostics, the filing is supported by completed clinical and analytical performance studies, including a clinical trial of more than 1,400 symptomatic patients across nine U.S. sites and an analytical program of 27 studies with over 10,000 PCR test runs, including a multicenter reproducibility study. The company states that, if the CLIA waiver is granted, the test could be used in waived point-of-care environments, supporting expanded access to PCR testing. Co-Diagnostics highlights that its Co-Dx PCR platform is designed to pair lower-cost instrumentation and consumables with cloud-based data aggregation to help track localized outbreaks, but notes the platform remains under FDA and other regulatory review and is not yet available for sale.
Co-Diagnostics (Nasdaq: CODX) announced it will release its second quarter 2026 financial results on Thursday, August 13, 2026, after market close. Management will discuss the results on a conference call and webcast the same day at 4:30 p.m. ET.
The event will feature CEO Dwight Egan, CFO Brian Brown, and Head of Investor Relations Andrew Benson. Investors can access the live webcast via the Events & Webcasts page at ir.co-dx.com or join by phone using the provided toll-free and toll numbers. A replay will later be available on the company’s website.
Co-Diagnostics (Nasdaq: CODX) reported two Ebola-related developments. Joint venture CoSara Diagnostics has supplied 200 SARAGENE Bundibugyo Virus Test kits to a third-party lab for analytical studies after a request from India’s Centre for Cellular and Molecular Platforms (C-CAMP), which supports India’s diagnostics preparedness.
The analytical work is expected to evaluate the assay’s limit of detection, repeatability, and reproducibility. Separately, Co-Diagnostics completed a proof-of-concept study of an extraction-free Co-Primers Ebola test on the Co-Dx PCR Pro point-of-care instrument using diluted plasma, described as the platform’s first blood-borne assay. CoSara is also developing a second-generation pan-Ebola assay for broader species detection. According to the company, the Co-Dx PCR platform and associated tests remain subject to regulatory review and are not yet available for sale.
Co-Diagnostics (Nasdaq: CODX) announced that its Indian joint venture, CoSara Diagnostics, has initiated clinical studies in India for a tuberculosis (TB/MTB) test on the CoSara PCR Pro point-of-care instrument. According to Co-Diagnostics, PCR Pro instruments, MTB test kits and proprietary sample preparation devices have been shipped and are now deployed in select laboratories across India for TB testing evaluation.
The decentralized platform uses the company’s patented Co-Primers technology to deliver real-time PCR results in about 30 minutes via a mobile app. Co-Dx PCR platform products, including PCR test kits and a sample lysis instrument, are expected to be manufactured and distributed in India under the CoSara brand. India represents a significant share of global TB burden, making it a strategically important market for expanding access to high-quality PCR testing. The Co-Dx PCR platform, including PCR Home, PCR Pro and associated tests, remains subject to regulatory review and is not yet available for sale.
Co-Diagnostics (Nasdaq: CODX) appointed Wes Lindsey, PhD, MBA as Chief Scientific Officer, bringing over 20 years of molecular diagnostics experience. According to Co-Diagnostics, he has led assay development teams responsible for more than a dozen FDA 510(k) submissions and CE-marked IVD assays, supporting regulatory and commercialization plans for the Co-Dx PCR platform, which remains under FDA and other regulatory review and is not yet available for sale.
Co-Diagnostics (Nasdaq: CODX) was invited by the Stop TB Partnership and the Global Fund to participate as a manufacturer partner in the UNOPS Global Implementation Workshop on Near Point of Care TB Diagnostics in Bangkok, Thailand, from July 8-10, 2026.
The event gathers TB programs, labs, researchers, donors, and agencies from 21 countries to share early experience with WHO-recommended NPOC diagnostics and translate new guidelines, including tongue swabs and sputum pooling, into policy and funding plans. Co-Diagnostics will provide hands-on access to its Co-Dx PCR platform* and Co-Dx PCR MTB test, designed for decentralized TB testing, though the platform remains subject to regulatory review and is not yet available for sale.
Co-Diagnostics (Nasdaq: CODX) completed clinical and analytical performance studies for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro instrument. Over 1,400 patients were enrolled at 9 U.S. sites, with 27 analytical studies and more than 10,000 PCR test cup runs. Data are intended to support a Dual FDA 510(k) and CLIA Waiver by Application submission for point-of-care use, targeted for Q3 2026. The platform remains subject to regulatory review and is not yet available for sale.
Co-Diagnostics (Nasdaq: CODX) reported that its Vector Smart mosquito abatement district customer base now spans 21 states, with four new full laboratory installs in June 2026. The expansion aligns with a Co-Dx webinar for prospective MAD customers during National Mosquito Control Awareness Week.
Vector Smart multiplex PCR tests target West Nile, multiple encephalitis viruses, Zika, dengue and chikungunya, supporting decentralized, in-house PCR testing and faster vector-borne disease surveillance for communities.
Co-Diagnostics (Nasdaq: CODX) hosted a delegation from joint venture partner CoMira Diagnostics from the Kingdom of Saudi Arabia for a week-long visit and June 17, 2026 event unveiling a future automated PCR test kit manufacturing line.
The planned technology transfer aims to bring Co-Dx's AI-enabled molecular diagnostics platform and scalable manufacturing capabilities to KSA and 18 other Middle Eastern and Northern African countries.
Co-Diagnostics (Nasdaq: CODX) signed an exclusive distribution agreement with its longstanding Mexico partner for the Co-Dx™ PCR point-of-care platform, including PCR Pro® and related test kits. The deal extends the relationship five years and supports Latin American commercialization ahead of required regulatory authorizations.
The partner has generated over $18 million in revenue for Co-Diagnostics since 2020 through Logix Smart® PCR tests and lab equipment sales. Logix Smart COVID-19 PCR tests accounted for over 50% of Mexico’s COVID-19 tests through 2021, based on public data.