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. (NASDAQ: CODX) is a pioneering molecular diagnostics company based in Sandy, Utah. The company is renowned for its unique, patented technology that significantly enhances the speed, performance, and cost-efficiency of DNA testing for a variety of diseases compared to traditional methods. Co-Diagnostics focuses on the development, manufacturing, and commercialization of its proprietary technologies through sales, development, and licensing agreements.
Co-Diagnostics’ core technology is protected by multiple patents and trade secrets, enabling revolutionary approaches in molecular diagnostics. These innovations have been utilized to develop a range of assays in the infectious disease sector, demonstrating the technology's exceptional capabilities. The company's patented inventions stem from advanced mathematical models designed by Dr. Brent C. Satterfield.
The firm’s product portfolio includes diagnostic tests for diseases such as tuberculosis, Zika, hepatitis B and C, malaria, dengue, and HIV. These tests utilize the detection and analysis of nucleic acid molecules (DNA or RNA) to provide accurate and efficient diagnostics. Co-Diagnostics also leverages its proprietary technology to create tests for its Co-Dx PCR platform, which includes at-home and point-of-care solutions.
One of the notable collaborations of Co-Diagnostics is its joint venture with CoSara Diagnostics Pvt Ltd in India. This partnership has led to regulatory clearance from India’s Central Drugs Standard Control Organization (CDSCO) for multiple diagnostic tests, including the SARAPLEX™ Influenza Multiplex (IFM) Test Kit, which differentiates between Influenza A and B strains.
Recently, Co-Diagnostics announced significant milestones, such as the opening of new manufacturing facilities in Salt Lake City, Utah, and Ranoli, India. These facilities will enhance the production of the company’s novel Co-Dx PCR Pro™ instrument and test cups, as well as the Co-Primers™ chemistry that is vital for its PCR diagnostic tests. The Salt Lake City facility, inaugurated with support from local dignitaries and business leaders, marks a critical step in expanding the company's production capabilities.
The company’s forward-looking strategies include submitting an Emergency Use Authorization (EUA) to the FDA for the Co-Dx PCR Pro™ instrument, mobile app, and COVID-19 test. This submission is part of Co-Diagnostics’ effort to decentralize PCR diagnostics and extend its reach to at-home and point-of-care settings. The company is also developing tests for tuberculosis, multiplex respiratory infections, and HPV, among others.
Co-Diagnostics’ financial performance and strategic initiatives are regularly discussed through conference calls and webcasts, involving key executives such as CEO Dwight Egan and CFO Brian Brown. The company remains committed to innovation and growth, aiming to provide accessible and high-quality diagnostic solutions worldwide.
Co-Diagnostics, Inc. (CODX) has completed an updated in silico analysis of its Co-Dx™ Logix Smart® Mpox (2-Gene) RUO test. The analysis shows that the test should maintain full reactivity against mpox strains circulating over the past year, including the more transmissible and severe clade Ib. This comes as the Africa CDC declared mpox a Public Health Emergency of Continental Security on August 13, 2024, followed by the WHO declaring it a public health emergency of international concern. As of August 27, 2024, Africa reported over 22,800 mpox cases and 622 deaths. The Company's 2-gene mpox test was previously shown to perform better at detecting mpox from saliva samples compared to other assays in a study published in December 2023.
Co-Diagnostics, Inc. (CODX) announced its participation in the 16th Annual Next Generation Dx Summit in Washington, D.C. from August 19-21, 2024. The company will sponsor, present, and host a booth at this event, which focuses on diagnostic advancement and technology innovation.
CEO Dwight Egan will present on the company's upcoming PCR platform, currently under FDA review, in a luncheon presentation titled "Co-Dx PCR Platform: The Future of Accessible Diagnostics" on August 19 at 12:15 PM ET.
Attendees can visit Booth #26 to learn about the Co-Dx PCR testing platform and the Co-Dx Logix Smart® suite of clinical laboratory solutions, including Research Use Only (RUO) tests for mpox virus. The company's mpox test was featured in a study published in the Oxford Academic journal Open Forum Infectious Diseases in December 2023.
Co-Diagnostics, Inc. (NASDAQ: CODX) reported its Q2 2024 financial results, showing improvements despite ongoing losses. Revenue increased to $2.7 million from $0.2 million in the prior year, primarily due to milestone achievements in grant agreements. The company reduced its operating loss to $7.7 million from $12.0 million in 2023, with a net loss of $7.6 million ($0.25 per share) compared to $8.9 million ($0.31 per share) last year.
Key highlights include submitting a 510(k) application to the FDA for the Co-Dx™ PCR Pro™ Platform, inaugurating a new manufacturing facility, and expanding vector control technology to Nevada. The company maintains a strong cash position of $44.9 million as of June 30, 2024.
Co-Diagnostics, Inc. (Nasdaq: CODX) announced its participation in the Association for Diagnostics & Laboratory Medicine (ADLM) annual meeting in Chicago from July 28-August 1, 2024. The company will host a booth and deliver a presentation on July 30 at 2:00 PM, focusing on their new Co-Dx™ PCR platform for at-home and point-of-care diagnostics. This platform aims to address the global diagnostics gap, with potential applications including tuberculosis (TB) testing.
Co-Dx recently submitted an FDA 510(k) application for a COVID-19 test using this platform. The company will showcase the Co-Dx PCR Pro™ instrument at Booth 2879 and present a scientific poster on July 31. CEO Dwight Egan and Executive VP Joseph Featherstone will discuss Co-Dx's role in the initiative to end TB by 2030. The new platform and associated tests are currently under FDA review and not yet available for sale.
Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company, has announced the release date for its second quarter 2024 financial results. The company will disclose its earnings on Thursday, August 8, 2024, after the market closes. Following the release, Co-Diagnostics will host a conference call and webcast at 4:30 p.m. ET to discuss the results with analysts and institutional investors.
The call will feature key management figures, including CEO Dwight Egan, CFO Brian Brown, and Head of Investor Relations Andrew Benson. Interested parties can access the webcast through the company's investor relations website or join the conference call using the provided domestic and international phone numbers. For those unable to attend live, a recording will be made available on the company's website later.
Co-Diagnostics (CODX), a molecular diagnostics company, announced the extension of its vector control customer base to 25 customers across 15 U.S. states. The expansion follows the upcoming installation of its vector control technology in Nevada. Co-Dx's Vector Smart® PCR tests are utilized in environmental surveillance of mosquito pools for diseases like West Nile virus, Zika, dengue, and chikungunya. The technology allows mosquito abatement districts to receive same-day results, facilitating quicker and more efficient disease prevention. CEO Dwight Egan highlighted the importance of this growth in combating the spread of mosquito-borne illnesses amid increasing threats from climate change.
Co-Diagnostics, a molecular diagnostics firm, will participate in the FIME 2024 trade show in Miami Beach, Florida from June 19-21. The company, known for its unique, patented platform for developing molecular diagnostic tests, will be hosted at the Utah booth. FIME is a premier medical trade expo attracting over 15,000 professionals and exhibitors from 116 countries. Co-Diagnostics will showcase its new Co-Dx PCR platform, which is under review by the FDA for Over-the-Counter (OTC) clearance. Attendees can visit Booth S61 to learn more about Co-Dx products, including the Co-Dx PCR Pro instrument and associated tests, which are currently under FDA review but not yet available for sale.
Co-Diagnostics (Nasdaq: CODX), a molecular diagnostics company, has submitted its first FDA 510(k) application for the Co-Dx PCR Pro instrument and OTC Co-Dx PCR COVID-19 Test. The application was submitted via the FDA's eSTAR system and acknowledged as received. The Co-Dx PCR platform aims to decentralize gold-standard PCR diagnostics, traditionally found in high-complexity labs, to home and point-of-care settings using a smartphone interface and Co-Primers technology. The company is also preparing to seek point-of-care clearance for the COVID-19 test and has diagnostics for tuberculosis, human papillomavirus, strep A, and a respiratory multiplex in development. CEO Dwight Egan stated this milestone would validate their platform's quality and expedite the completion of tests for other indications and regions.
Co-Diagnostics, Inc. reported its First Quarter 2024 Financial Results, showcasing a revenue of $0.5 million, down from $0.6 million in the prior year. Operating expenses increased by 4.4% due to research and development costs. The company reported an operating loss of $10.3 million and a net loss of $9.3 million. Adjusted EBITDA loss was $8.4 million. Co-Diagnostics highlighted key business highlights, including new executive appointments and facility expansions in Salt Lake and India. The company is focused on FDA submissions for new products and continued test development for various conditions.
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