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 (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.
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.
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