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 (CODX) has announced the withdrawal of its current 510(k) FDA application for the Co-Dx™ PCR COVID-19 Test on the PCR Pro™, with plans to submit an enhanced version. The withdrawal follows FDA feedback regarding shelf-life stability concerns of a test component.
The company reports positive engagement with the FDA and satisfactory test performance in clinical evaluations. The decision to submit an enhanced version allows Co-Dx to address stability issues and incorporate recent platform developments, potentially improving operational and manufacturing efficiencies.
Moving forward, Co-Dx plans to submit the enhanced COVID-19 test for 510(k) OTC clearance after collecting new clinical evaluation data. The company's pipeline includes future tests for tuberculosis, upper-respiratory multiplex, and HPV. The Co-Dx PCR platform remains under regulatory review and is not yet available for sale.
Co-Diagnostics (CODX) announced its participation at BioUtah's Life Sciences Day on the Hill at the Utah State Capitol Rotunda on January 30, 2025. The event, presented by the Utah Life Sciences Innovation Caucus, the Utah Governor's Office of Economic Opportunity, and BioUtah, features over 25 Utah life sciences companies.
At the event, Co-Dx will showcase its upcoming Co-Dx PCR testing platform for at-home and point-of-care detection of infectious diseases, including COVID-19, influenza, RSV, HPV, and tuberculosis. The platform features cloud-based analysis capabilities for tracking disease outbreaks and is operated through a smartphone interface.
The company notes that the Co-Dx PCR platform, including the Co-Dx PCR Home™, Co-Dx PCR Pro™, mobile app, and associated tests and software, is currently under FDA review and not yet available for sale.
Co-Diagnostics (CODX) announced its participation in Nasdaq's Live from MarketSite broadcast at the Silicon Slopes Summit 2025 on January 14, 2025. CEO Dwight Egan will discuss the upcoming Co-Dx PCR platform and its test pipeline for various diseases, including COVID-19, tuberculosis, HPV, and an upper respiratory multiplex panel.
The company's Co-Dx™ Logix Smart® ABC Test currently detects all known H5N1 strains and is available as a Research Use Only (RUO) assay in the US and as an in vitro diagnostic in CE-marking regions. The company has also completed design work for an H5N1-specific target and is prepared to launch an updated 3-gene version of their mpox test.
Amid a post-holiday COVID-19 surge, the company continues to develop solutions for infectious diseases, including HMPV, H5N1, and mpox. The broadcast will be available on Nasdaq's Live from MarketSite webpage and the company's social media platforms.
Co-Diagnostics (NASDAQ: CODX) announced the inauguration of CoSara Diagnostics' new oligonucleotide synthesis facility on December 11, 2024, in Ranoli, India. The facility will manufacture Co-Primers® chemistry for PCR diagnostic tests and test cups for Co-Dx's PCR testing platform, supporting the 'Make in India' initiative.
The facility aims to enhance manufacturing efficiency and facilitate access to India's healthcare market. CoSara, a joint venture between Ambalal Sarabhai Enterprises and Co-Diagnostics, plans future expansion for manufacturing the Co-Dx PCR Pro instrument and test cups for diseases like TB and HPV. The WHO reported 10.8 million TB cases in 2023, with 1.25 million deaths, making it likely the world's leading cause of death from a single infectious agent.
Co-Diagnostics (NASDAQ: CODX) reported Q3 2024 financial results with revenue of $0.6 million, down from $2.5 million in the prior year. The company posted a net loss of $9.7 million ($0.32 per share) compared to $6.0 million ($0.20 per share) in 2023. Operating expenses decreased 5% to $10.6 million. The company maintains a strong cash position of $37.7 million. Business highlights include expansion of vector control business to 15 states and preparation for inauguration of oligonucleotide manufacturing facility in India. The company continues FDA dialogue for 510(k) application review and advances its test pipeline development.
Co-Diagnostics (CODX) announced its participation in MEDICA 2024, the world's largest medical B2B trade fair, scheduled for November 11-14 in Düsseldorf, Germany. The event attracts 83,000 visitors and over 5,300 exhibitors from nearly 70 countries.
The company will showcase its PCR diagnostic products and Co-Primers® technology at Booth #3 D15-1. Additionally, they will deliver a presentation titled 'Advancing POC/OTC Diagnostics: Innovations in Test Development for the Co-Dx PCR Platform' on November 13 at 12:05 PM CET in Hall 8A Booth G40. The presentation will focus on their upcoming Co-Dx PCR platform, which is currently under FDA review.
Co-Diagnostics (NASDAQ: CODX) announced it will release its third quarter 2024 financial results on Thursday, November 7, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET the same day, featuring CEO Dwight Egan, CFO Brian Brown, and Head of Investor Relations Andrew Benson. The event will be accessible via webcast on the company's investor relations website and through conference call lines. A recording will be available later on the company's website for those unable to attend live.
Co-Diagnostics, Inc. (Nasdaq-CM: CODX) announced its participation in Africa Health/Medlab Africa in Cape Town, South Africa from October 22-24, 2024. The conference is described as the largest gathering of healthcare companies in the sub-Saharan region. Co-Dx views this trade show as an opportunity to gain insight into markets expected to play a significant role in the company's future.
The company highlighted the importance of the African market, citing a WHO report estimating 2.5 million tuberculosis cases in the African Region in 2021. Co-Dx is developing several infectious disease tests, including one for TB, on its upcoming Co-Dx™ PCR at-home and point-of-care platform. The company also mentioned its Logix Smart® Mpox (2-Gene) RUO test, which is expected to retain full reactivity against known mpox strains.
Interested parties can visit Co-Dx at Booth H1/B1 during the conference.
Co-Diagnostics, Inc. (Nasdaq-CM: CODX) has announced its participation in the Utah Health Care Association/Utah Center for Assisted Living (UHCA/UCAL) Convention & Expo on October 2-3, 2024. The event will take place at the Mountain America Expo Center in Sandy, Utah.
The company will host Booth 300, showcasing its upcoming Co-Dx PCR platform, including a menu of at-home and point-of-care tests in development. The convention caters to executive leadership, administrators, corporate personnel, owners, and Directors of Nursing for skilled nursing, assisted living, and intermediate care facilities.
Interested parties are invited to visit Co-Diagnostics' booth to learn more about their diagnostic products and their applications in the healthcare sector. It's important to note that the Co-Dx PCR platform, including associated tests and software, is currently under review by the FDA and other regulatory bodies and is not yet available for sale.
Co-Diagnostics, Inc. (Nasdaq-CM: CODX) announced its participation in the World Trade Center (WTC) Utah trade mission to South Korea and Japan from September 24-October 5, 2024. The company will join Utah Governor Cox and the Governor's Office of Economic Opportunity delegation for life sciences and innovation. This mission aims to expand Co-Dx's international relationships as it prepares to introduce a new PCR diagnostic platform for at-home and point-of-care use.
Co-Diagnostics has a history of international ventures, including a joint venture in India established in 2017 and a network of distributors, partners, and customers in over 50 countries. The company's CEO, Dwight Egan, emphasized the importance of building global relationships to improve access to care and increase the availability of high-quality PCR diagnostics worldwide.
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